RRC APPLICATION FORM

RESEARCH PROTOCOL NUMBER: PR-10001
FOR OFFICE USE ONLY
RRC Approval: Yes / ERC Approval: Yes / AEEC Approval: Yes / External IRB Approval: Yes / Name of IRB: No No No Date:      Date:      Date:      No Date:     

Protocol Title: Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in

Bangladesh
Short title (in 50 characters including space): Peer conselling infant feeding education program Theme: (Check all that apply) Nutrition Emerging and Re-emerging Infectious Diseases Population Dynamics Reproductive Health Vaccine Evaluation HIV/AIDS Environmental Health Key words: Peer counselling, Infant, Intervention, breastfeeding, complementary feeding, stunting Relevance of the Protocol: Health Services Child Health Clinical Case Management Social and Behavioral Sciences Gender Human Rights Others (please specify___________________)

Poor nutritional status of children is a major public health problem throughout the developing world and is the underlying cause for 55% of child deaths and 11% of the total global disease burden. Inappropriate complementary feeding is an important predictor of poor growth and morbidity in infants and young children. The proposed research will evaluate an intervention to promote and sustain optimal feeding in children aged 0-24 months. This research builds on the prior experience of members of the research team with the use of peer counselling to improve feeding practices in infants aged 0-6 months. Risk factors of suboptimal breastfeeding and complementary feeding in Bangladesh will be taken into account when designing the peer counselling materials for improving infant and young child feeding. This study will help fill this evidence gap about effective interventions to improve infant and young child feeding and prevent childhood malnutrition in Bangladesh.
Centre’s Priority (as per Strategic Plan, to be imported from the attached Separate Word Sheet):

1.5. Strengthen child health and development interventions through research on effective child caring, stimulation and health-seeking practices in the homes. 3.3 Improving child feeding including increasing rates of exclusive breastfeeding and appropriate and adequate complementary feeding.
Programmes: Child Health Programme Nutrition Programme Programme on Infectious Diseases & Vaccine Science Poverty and Health Programme Health and Family Planning Systems Programme Principal Investigator (Should be a Centre’s staff) Dr. A.K.M. IQBAL KABIR Address (including e-mail address): Population Programme Reproductive Health Programme HIV/AIDS Programme Gender, Hunman Rights and Health Programme Others (please specify___________________)

DIVISION:
CSD HSID LSD PHSD

Scientist, ICDDR,B, Mohakhali, Dhaka-1212, Emailikabir@icddrb.org, 8860523-32(2312)

Principal Investigator(s): External Dr. Michael J Dibley, Associate Professor in International Public Health at the School of Public Health, the George Institute for International Health, University of Sydney. Email: mdibley@health.usyd.edu.au Co-Principal Investigator(s): Internal Dr. S. K. Roy, Senior, Scientist, ICDDR,B, Mohakhali, Dhaka-1212, Email-skroy@icddrb.org, 886052332(2313)
Co-Investigator(s): Internal: Dr. Anadil Alam, Research Investigator, HSID, ICDDR,B; e-mail: anadil@icddrb.org Co-Investigator(s): External: Seema Mihrshahi| Postdoctoral Research Fellow | Institute of Health and Biomedical Innovation Queensland University of Technology | 60 Musk Ave, Kelvin Grove, QLD, 4059, Australia t: +617 3138 6171| f: +617 3138 6030 | e: seema.mihrshahi@qut.edu.au | w: www.ihbi.qut.edu.au Co-Investigator(s): External (Please provide full official address including e-mail address and Gender)

Kingsley E. Agho, Research Fellow in biostatistics at the School of Medicine, University of Western Sydney, Australia. Email: K.Agho@uws.edu.au
Student Investigator(s): Internal (Centre’s staff):

     
Student Investigator(s): External: (Please provide full address of educational institution and Gender)

     
Collaborating Institute(s): Please Provide full address Institution # 1 Country Contact person Department (including Division, Centre, Unit) Institution (with official address) Directorate (in case of GoB i.e. DGHS) Ministry (in case of GoB) Australia Michael J. Dibley Associate Professor in International Public Health The University of Sydney, Room no-307 A, Edward Ford Building (A 27) NSW 2006, Australia            

Institution # 2

Institution # 3 Country Contact person Department (including Division, Centre, Unit) Institution (with official address) Directorate (in case of GoB i.e. DGHS) Ministry (in case of GoB)                                    

Note: If more than 3 collaborating institutions are involved in the research protocol, additional block(s) can be inserted to mention its/there particular(s).

Population: Inclusion of special groups (Check all that apply): Sex Male Female Age 0 – 4 years 5 – 10 years 11 – 17 years 18 – 64 years 65 + NOTE Pregnant Women Fetuses Prisoners Destitutes Service Providers Cognitively Impaired CSW Others (specify      ) Animal

It is the policy of the Centre to include men, women, and children in all research projects involving human subjects unless a clear and compelling rationale and justification (e.g. gender specific or inappropriate with respect to the purpose of the research) is there. Justification should be provided in the `Sample Size’ section of the protocol in case inclusiveness of study participants is not proposed in the study. Project/study Site (Check all the apply): Dhaka Hospital Matlab Hospital Matlab DSS Area Matlab non-DSS Area Mirzapur Dhaka Community Chakaria Abhoynagar Mirsarai Patyia Other areas in Bangladesh       Outside Bangladesh Name of Country:       Multi Centre Trial (Name other countries involved):      

preferably at the https://register. Targeted Population (Check all that apply): No ethnic selection (Bangladeshi) Bangalee Tribal group Consent Process (Check all that apply): Written Oral None Bengali Language English Language Expatriates Immigrants Refugee . If YES.Type of Study (Check all that apply): Case Control Study Community-based Trial/Intervention Program Project (Umbrella) Secondary Data Analysis Clinical Trial (Hospital/Clinic) Family Follow-up Study NOTE: Does the study meet the definition of clinical studies/trials Journal Editors (ICMJE)? Yes No Cross Sectional Survey Longitudinal Study (cohort or follow-up) Record Review Prophylactic Trial Surveillance/Monitoring Others:       given by the International Committee of Medical Please note that the ICMJE defined clinical trial as “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome”. after approval of the ERC. the PI should complete and send the relevant form to provide required information about the research protocol to the Committee Coordination Secretariat for registration of the study into websites.clinicaltrials. It may please be noted that the PI would require to provide subsequent updates of the research protocol for updating protocol information in the website.gov/.

alcohol use or illegal conduct such as drug use? Could the information recorded about the individual if it became known outside of the research: . name of institution(s) and country(ies): ___________________________________________________________ g) Will the surplus/unused specimen be returned to the Centre? Yes No NA h) Who will be the custodian of the specimen at the Centre and when shipped outside of the country(ies)?: _________________________________________________________ i) Who will be the owner(s) of the samples? : __________________________________________________________ Yes No NA j) Has a MoU been made for the protocol covering the specimen collection. Men. use and ownership? k) If yes. for unrelated use without further taking consent? d) What types of tests will be carried out with the preserved samples? __________________________________________ ____________________________________________________________________________________________ e) Will the samples be shipped to other country(ies)? Yes No NA f) If yes.Proposed Sample Size: Sub-group (Name of subgroup (e. Yes No NA Yes No Name Number             c) Will consent be obtained from study participants for the specimen be stored for future. Determination of Risk: Does the Research Involve (Check all that apply): Human exposure to radioactive agents? Fetal tissue or abortus? Human exposure to infectious agents? Investigational new device? Investigational new drug Existing data available via public archives/sources (specify:      ) Pathological or diagnostic clinical specimen only Existing data available from Co-investigator Observation of public behaviour New treatment regime No No Is the information recorded in such a manner that study participants can be identified from information provided directly or through identifiers linked to the study participants? Does the research deal with sensitive aspects of the study participants’ behaviour. storage. sexual behaviour. please attach a copy. Women) and Number Name (1) Intervention Group ( Women. boys & girls) (2) Control Group (Women. how long the specimens be preserved? _____ years.g. boys & girls) Number 975 975 (3)       (4)       Total sample size: 1950 a) Will the specimen be stored for future use? b) If yes.

complete and accurate to the best of my knowledge. Dates of Proposed Period of Support (Day. the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as a part of routine physical examination. Year .6 38 0 912. I agree to accept the responsibility for the scientific conduct of the project and to provide the required progress reports including updating protocol information in the SUCHONA (Form # 2) if a grant is awarded as a result of this application. psychological examinations or tests.Do you consider this research (Check one): Greater than minimal risk No more than minimal risk Only part of the diagnostic test Minimal Risk is the risk when the probability and magnitude of the anticipated harm or discomfort in participating in the proposed research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical. Month.g.g. Direct Cost                               0 Indirect Cost                               0 Cost Required for the Budget Period ($) Total Cost (AUD ) 256.DD/MM/YY) Beginning Date : 01/01/2010 End Date : 31/12/2013 Years Year-1 Year-2 Year-3 Year-4 Year-5 Total Certification by the Principal Investigator I certify that the statements herein are true.2 00 167. I am aware that any false. sponsor Name: (1) (2) NHMRC       Yes/No/NA (if the proposal is already funded.3 25 261. name of funding agency: (1)       (2)       Do any of the participating investigators and/or member(s) of their immediate families have an equity relationship (e.3 25 227. civil. a written statement of disclosure to be submitted to the Centre’s Executive Director. Yes/ No Is the proposal funded? If yes. mark NA) Is the proposal being submitted for funding? If yes. stockholder) with the sponsor of the project or manufacturer and/or owner of the test product or device to be studied or serve as a consultant to any of the above? IF YES.4 88 ___________ Signature of PI __30-12-09__________ Date . fictitious. or fraudulent statements or claims may subject me to criminal. or administrative penalties. e.

The protocol has been revised according to the reviewers’ comments and is approved.K.Approval of the Project by the Division Director of the Applicant The above-mentioned project has been discussed and reviewed at the Division level as well by the external reviewers. Iqbal Kabir (Acting ) Name of the Division Director Signature 30-12-09 Date of Approval . A. Dr.M.

.....................................................................................................................................................38 Biography of the Investigators..........46 Other Support...................................................................................49 Purpose of the research..........................................................14 Research Design and Methods.........................................................21 Facilities Available...................................................................................................................................71 M‡elYvi D‡Ïk¨:Ñ.............................................. defending the proposal at institutional review committees...........................................................B that protects the interest of research participants will have an access to your information...........................................................................................................................................................................................................................35 Biography of the Investigators .......................................................... Cambridge University and Institute for Child Health.......................70 What is expected from the participants of the research study?.................................... monitoring of quality and progress...............................................................................................................................................................................29 Approval...................................................... 1982...............................13 Background of the Project including Preliminary Observations ....70 Risk and benefits.......................................................................................................................................................................... If you wish we will inform you any results of your own..............................71 Privacy............................................................39 Biography of the Investigators.............................................................................................................................................................................................71 We will keep all of your information strictly confidential.......................................................................................................................................... Dunn Nutrition Unit......................................................................................................34 Dissemination and Use of Findings..........................................................................1 Project Summary.....................46 PI: Will spent 25% of time and be responsible for overall design.......................................................................................................................................................................................................................................................... and in data analyses and report writing....................................................................................................................................................................................13 Specific Aims:.............................................................................................................................................................. checking at least 5% data in the field...........................31 Ethical Assurance for Protection of Human Rights.......................................................................................43 Biography of the Investigators .....41 Biography of the Investigators .........................................................................................................................18 Sample Size Calculation and Outcome (Primary and Secondary) Variable(s).. coordination with relevant persons and departments..........................................................................................................48 Check-List.........45 Budget Justifications.....................................................................................................................................Table of Contents RRC APPLICATION FORM....................................70 Why are we inviting you to participate in the study? ........34 Use of Animals.............71 Future use of information............................................................................................................22 Data Safety Monitoring Plan (DSMP)................................................................................36 Postgraduate Training in Nutrition in Health and Disease...................34 Literature Cited............................................................................................................................................................................31 Pilot study......... training of staff.................................. University of London.........................73 Dbœqbkxj †`‡ki g‡a¨ evsjv‡`‡ki wkï‡`i g‡a¨ Acywói e¨cKZvi nvi cÖej| cix¶vq ‡`Lv wM‡q‡Q ‡h h_vh_ AvBIqvBwZGd Øviv 1/5 wkï g„Zz¨ nvi K‡g‡Q Ges Acywó `~ixKi‡b ¸iyZ¡c~iY fywgKv iv‡L| 54% wkï g„Zz¨ Ges 11% wewfbœ ai‡bi Amy‡Li cÖavb Kvib GB Acywó| 18 gv‡mi wkï Lv`¨vfvm DbœZ Kivi Rb¨ eZ©gv‡b †Kvb ai‡bi civgk© Kvh©µg we‡kl K‡i mZx_© civgk© Pvjy †bB| civgk© Kvh©µ‡gi mydj Ges civgk© `v‡bi Dchy³ mgq Avgv‡`i †`‡ki Acywó `~ixKi‡b ¸iyZ¡c~iY fywgKv ivL‡e| Dbœqbkxj †`‡ki RbmsL¨v cwiKíbvKvix‡`i Rb¨ GwU GKwU AZ¨š— AvKl©bxq cwiKíbv n‡Z cv‡i| Avkv Kiv hvq GB M‡elbv n‡Z cªvß djvdj cÖKvwkZ n‡j wkï‡`i .......................................... anonymity and confidentiality.............13 Hypothesis to be Tested:............. and none other than the staff of our study and the Ethical Review Committee of ICDDR..................................................11 Description of the Research Project...............................35 Collaborative Arrangements....................................................................31 Training.............................

........................................................................110 Check here if appendix is included ........................ `y»`v‡bi Rb¨ †evZ‡ji e¨envi m¤ú‡K© wKQy cÖkœ Kie| Avgiv AviI Rvb‡Z PvBe †h cvwievwiK I cvovc«wZ‡Ÿkx Ÿv AvÍxq bq Ggb ‡Kn Avcbv‡K beRvZ‡Ki Lv`¨vfvm m¤ú‡K© Dc‡`k w`‡q‡Q Ges MZ 24 N›Uvq KZevi wkïwU Lv`¨ MÖnb K‡i‡Q| Avgiv Avcbvi IRb I D”PZv Ges Avcbvi wkïi IRb................................................................................................................................................................................................................................................73 Purpose of the research....... If you wish we will inform you any results of your own.............. k³ ev Zij Lvevi ïi“ Kivi mgq..................................78 Dbœqbkxj †`‡ki g‡a¨ evsjv‡`‡ki wkï‡`i g‡a¨ Acywói e¨cKZvi nvi cÖej| cix¶vq ‡`Lv wM‡q‡Q ‡h h_vh_ AvBIqvBwZGd Øviv 1/5 wkï g„Zz¨ nvi K‡g‡Q Ges Acywó `~ixKi‡b ¸iyZ¡c~iY fywgKv iv‡L| 54% wkï g„Zz¨ Ges 11% wewfbœ ai‡bi Amy‡Li cÖavb Kvib GB Acywó| 18 gv‡mi wkï Lv`¨vfvm DbœZ Kivi Rb¨ eZ©gv‡b †Kvb ai‡bi civgk© Kvh©µg we‡kl K‡i mZx_© civgk© Pvjy †bB| civgk© Kvh©µ‡gi mydj Ges civgk© `v‡bi Dchy³ mgq Avgv‡`i †`‡ki Acywó `~ixKi‡b ¸iyZ¡c~iY fywgKv ivL‡e| Dbœqbkxj †`‡ki RbmsL¨v cwiKíbvKvix‡`i Rb¨ GwU GKwU AZ¨š— AvKl©bxq cwiKíbv n‡Z cv‡i| Avkv Kiv hvq GB M‡elbv n‡Z cªvß djvdj cÖKvwkZ n‡j wkï‡`i ¯^v†¯’¨i Dci ¸i“Z¡c~ib cÖfve †dj‡e| `w¶Y Gwkqvi wkï‡`i Rb¨ Rb¯^v¯’¨ I cywó welqK cwiKíbvi Dbœqb Kiv hv‡e.............. hvi Øviv wkï‡`i ¯^v‡¯’¨I DbœwZ‡Z e¨cK f~wgKv ivL‡e| .....................76 What is expected from the participants of the research study?................................................. ga¨ evûi cwigvcGes 24 N›Uvq †m †h Lv`¨ MÖnb K‡i Zv cwigvc Kie| GB cy‡iv cÖwµqvwUi Rb¨ Avcbvi 1 N›Uv mgq Avgv‡`i `iKvi n‡e| Avgiv Avcbv‡K m¤^wjZ Av‡jvPbv‡Z AskMÖnb Kivi Rb¨ Avgš¿b hvbvw”Q | GB Av‡jvPbv‡Z AskMÖnb Kivi Rb¨ Avcbvi 1 N›Uv mgq Avgv‡`i `iKvi n‡e|...........¯^v†¯’¨i Dci ¸i“Z¡c~ib cÖfve †dj‡e| `w¶Y Gwkqvi wkï‡`i Rb¨ Rb¯^v¯’¨ I cywó welqK cwiKíbvi Dbœqb Kiv hv‡e..............................................................................................................................................78 Avcwb hw` GB M‡elYv Kv‡R AskMÖnb Ki‡Z m¤§Z nb Z‡e Avgiv Avcbv‡K Avcbvi Av_© mvgvwRK Ae¯’v.................................................................... ˆ`N¨©............................................73 Avcwb hw` GB M‡elYv Kv‡R AskMÖnb Ki‡Z m¤§Z nb Z‡e Avgiv Avcbv‡K Avcbvi Av_© mvgvwRK Ae¯’v................................................................ wkïi Rb¨ eZ©gv‡b Zij I k³ Lvev‡ii e¨e¯’v. and none other than the staff of our study and the Ethical Review Committee of ICDDR................76 M‡elYvi D‡Ïk¨:Ñ......................................76 Risk and benefits.................................................................................................................. k³ ev Zij Lvevi ïi“ Kivi mgq............................. ˆ`N¨©...............................76 Privacy............................B that protects the interest of research participants will have an access to your information....................76 Future use of information..................................... anonymity and confidentiality...................................79 SzuwK Ges DcKvixZv:.......76 We will keep all of your information strictly confidential.... wkïi Rb¨ eZ©gv‡b Zij I k³ Lvev‡ii e¨e¯’v.............................. ga¨ evûi cwigvcGes 24 N›Uvq †m †h Lv`¨ MÖnb K‡i Zv cwigvc Kie| GB cy‡iv cÖwµqvwUi Rb¨ Avcbvi 1 N›Uv mgq Avgv‡`i `iKvi n‡e| Avgiv Avcbv‡K m¤^wjZ Av‡jvPbv‡Z AskMÖnb Kivi Rb¨ Avgš¿b hvbvw”Q | GB Av‡jvPbv‡Z AskMÖnb Kivi Rb¨ Avcbvi 1 N›Uv mgq Avgv‡`i `iKvi n‡e|.....73 SzuwK Ges DcKvixZv:................... `y»`v‡bi Rb¨ †evZ‡ji e¨envi m¤ú‡K© wKQy cÖkœ Kie| Avgiv AviI Rvb‡Z PvBe †h cvwievwiK I cvovc«wZ‡Ÿkx Ÿv AvÍxq bq Ggb ‡Kn Avcbv‡K beRvZ‡Ki Lv`¨vfvm m¤ú‡K© Dc‡`k w`‡q‡Q Ges MZ 24 N›Uvq KZevi wkïwU Lv`¨ MÖnb K‡i‡Q| Avgiv Avcbvi IRb I D”PZv Ges Avcbvi wkïi IRb....75 Why are we inviting you to participate in the study? ................................79 Do you prepare the complementary food with oil for your child? /__/__/...................................... hvi Øviv wkï‡`i ¯^v‡¯’¨I DbœwZ‡Z e¨cK f~wgKv ivL‡e| ........

.

and also the experimental design and research methods for achieving the objectives.7% of the global disabilityadjusted life years in children less than five years of age. The main aim of the study is to use a cluster RCT to collect high-level evidence of whether peer counselling of women to promote appropriate breastfeeding and complementary feeding can improve feeding practices. Using a similar approach to recruitment. Outcome assessments will be conducted with all the mother-infant pairs recruited in the community clusters in the study.Project Summary Briefly describe the hypothesis. a cohort of mother-infant dyads.g. Childhood malnutrition is a pervasive problem in Bangladesh with 43% of children less than five years stunted in 2004 and 38% in urban child populations. child growth and reduce the prevalence of malnutrition in their children.. M. The peer counseling education will be offered to eligible pregnant women identified by household surveys over 3 months in each community cluster in the intervention group. child growth and reduce the prevalence of malnutrition in their children.488 Beginning Date : January 2010 Ending Date: December 2013 Child undernutrition remains a highly prevalent condition in low and middle income countries and a major portion of the global burden of childhood malnutrition is found in South Asia with an estimated 74 million children living with chronic malnutrition (stunted growth) in this region. The outcome assessments will be made on a cohort of infant-mother dyads measured at baseline and at follow up visits because we expect a likely high correlation between baseline and follow up outcome measures. A. to improve child feeding practices. and the relevant background of the project. thus making this approach the most efficient study design. e. and be fully understandable and interpretable when removed from the main application. children with height-for-age <-3 Z scores from the standard have a four fold increased mortality risk compared to children within one Z score of the growth standard mean. The risk of child death is also related to the severity of malnutrition and progressively increases the more the child’s growth deviates from WHO Growth Standard. Principal Investigator: Dr. K. This will result in two study groups. This description will serve as a succinct and precise and accurate description of the proposed research is required. A recent study has conducted on pioneering research on this approach in Bangladesh. This burden of malnutrition accounts for approximately 50% of under five child deaths in developing countries. We will use a community-based CRCT to examine the impact of a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery. objectives. This summary should be stand alone. who will receive standard maternal . Underweight in children for 18. Iqbal Kabir Research Protocol Title: Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh Total Budget AU$: 912. An establish approach to promoting appropriate breastfeeding practices is through the use of local peer counsellors to provide information and to support to mothers. with an expected total of 1950 mother-infant days (975 in each treatment group).

Kingsley E. 5.g. K. feeding patterns. K.g.and child health care programs. and mean nutrient intakes) taking account of the repeated measurements within children by using separate mixed models. Secondary analyses will examine each outcome variable (stunting. We will report the results for 2-sided 5% tests for the primary trial outcome.g. 4. Michael J Dibley Dr. Agho Dr. Dr.       . feeding practices and hygiene and caring practices etc. logistic mixed models for binary outcomes e. A. 6. 3. M. will be identified in the control clusters. KEY PERSONNEL (List names of all investigators including PI and their respective specialties) Name 1. 9. 7. It is expected that the publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited. We will use linear mixed models for continuous outcomes (e. 8. 2. Roy Seema Mihrshahi Dr. S. height-for-age Z) and generalized linear mixed models for non-continuous outcomes (e. Anadil Alam                   Professional Discipline/ Specialty Clinical and Public health nutrition scientist Nutritional epidemiologist Clinical and Nutrition Research Public Health research Public Health and Demoghraphy Clinical & Public Health Nutrition                         Role in the Project Principal Investigator Principal Investigator Co-Principal Investigator Co-Investigator Co-Investigator Associate Investigator                         10. percentage exclusively breastfeeding). Data will be collected on anthropometry. height-for-age. Iqbal Kabir Dr.

the aims of the trial are to evaluate if a peer counselling. Specific Aims: Describe the specific aims of the proposed study. in the peer counselling group. in the peer counselling group. Secondary objectives 1) The percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 3 and 6 months will be increased. biological functions.Description of the Research Project Hypothesis to be Tested: Please briefly list the Hypothesis to be tested and provide the scientific basis of the hypothesis. compared with mothers without the intervention. child growth and reduce the prevalence of malnutrition in their children. . 3) The percentage of women bottle feeding (any liquid or semi-solid food from a bottle with nipple/teat) their infants at 12 months will be decreased. compared with mothers without the intervention. rates. processes etc. We hypothesised that in a community-based. and 2) Improves the growth and reduces the prevalence of stunting of their children at 18 months. State the specific parameters. critically examining the observations leading to the formulation of the hypothesis. in the peer counselling group. 2) The mean duration of any breastfeeding will be increased. cluster randomized controlled trial (CRCT) of women from a socio-economically disadvantaged community in Bangladesh. a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery will reduce the prevalence of stunting (height-for-age < -2 Z) in their children at 18 months of age by 10% (35% in control to 25% in intervention group) compared with women with no peer counselling. Main objective: The main aim of the study is to use a cluster RCT to collect high-level evidence of whether peer counselling of women to promote appropriate breastfeeding and complementary feeding can improve feeding practices. compared with mothers without the intervention. that will be assessed by specific methods. behavioural change education program for women: 1) Improves breastfeeding and complementary feeding of their children. Specifically.

[5] It is recommended that children be exclusively breastfeed until 6 months of age. in the children in the peer counselling group. Describe in a logical way how the present hypothesis is supported by the relevant background observations including any preliminary results that may be available. vitamin A) from complementary feeds at 9.7% of the global disability-adjusted life years in children less than five years of age.[1] Underweight in children for 18. fat and selected micronutrients (e. children with height-for-age <-3 Z scores from the standard have a four fold increased mortality risk compared to children within one Z score of the growth standard mean. Also include the significance and rationale of the proposed work by specifically discussing how these accomplishments will bring benefit to human health in relation to biomedical. protein. 15 and 18 months will be increased.g. carbohydrate. in peer counselling group.[4] The risk of child death is also related to the severity of malnutrition and progressively increases the more the child’s growth deviates from WHO Growth Standard. iron. 6) Mean intake of food energy. e. zinc. compared with mothers without the intervention.[5] Childhood malnutrition is a pervasive problem in Bangladesh with 43% of children less than five years stunted in 2004 and 38% in urban child populations. in the peer counselling group.[6] Suboptimal feeding is also an important contributor to child mortality accounting for 10% of the global DALYs for children younger than 5 years of age. This burden of malnutrition accounts for approximately 50% of under five child deaths in developing countries. social. 12. 15 and 18 months will be increased. Infant feeding and child malnutrition Child undernutrition remains a highly prevalent condition in low and middle income countries and a major portion of the global burden of childhood malnutrition is found in South Asia.g. indicate the need to develop new knowledge. and discuss the previous works on the research topic by citing specific references. 12.[1] with an estimated 74 million children living with chronic malnutrition (stunted growth) in this region. 5) The percentage of children consuming foods from >4 food groups at 9. although in Bangladesh in 2004 the prevalence of this feeding practise was only 36%[6] Infants less than 6 months who are not breastfed have a 14 fold increased mortality risk compared to exclusively breastfed infants. Background of the Project including Preliminary Observations Provide relevant background of the proposed study.[1] Even infants less than 6 ..4) The percentage of children at 6 and 9 months of age who receive solid. If there is no sufficient information on the subject. compared with mothers without the intervention. Provide scientific validity of the hypothesis on the basis of background information Critically analyze available knowledge in the field of the proposed study and discuss the questions and gaps in the knowledge that need to be fulfilled to achieve the proposed goals. and environmental perspectives. semi-solid or soft foods will be increased. compared with mothers without the intervention.

[5] In the studies included in this meta-analysis the education messages were delivered by health care providers at routine contacts with health system. A recent study has conducted on pioneering research on this approach in Bangladesh. To date there have been no reports of using a peer support approach to educate.months who are just given water-based liquids in addition to breastmilk have a 48% increased mortality risk compared to exclusively breastfed infants.[1] Inappropriate breastfeeding increases the risks of childhood morbidity. Peer counsellors were identified from a community in which they had been delivering peer support for exclusive breastfeeding and starting complementary feeding at around six months of life. For example animal-source foods are an important source of protein micronutrients. and low intakes of these foods are related to stunting in children.[2] This occurs because at this age children have a higher demand for nutrients and also a higher rate of infectious diseases such as diarrhoea. These peer counsellors were given . Education about complementary feeding has been reported in a meta-analysis to increase height-forage Z score by 0·25 (95% CI 0·01–0·49). Although strategies for promoting appropriate breastfeeding have a large effect on survival. growth faltering will occur if children do not receive an adequate quantity and quality of complementary foods after 6 months of age. their effect on stunting appears to be much smaller. Bangladesh.[1] Improved breastfeeding practices and more diverse foods and increased frequency of complementary feeds can help protect infants from childhood malnutrition.[5] Similar results were also reported for group peer counselling. 1·18–3·15. p<0·0001. support and skill mothers about appropriate complementary feeding. which in turn potentially contributes to the development of stunting and wasting. which adversely affects growth and nutritional status.[5] Most postnatal growth faltering occurs during the first 2 years of life. 95% CI 2·20–5·42. and studies have shown that even with optimum breastfeeding. random effects) and at 6 months of age (nine studies. A lack of diversity of foods given to young children also contributes to malnutrition. such as zinc. 1·93. Peer counselling and infant feeding An establish approach to promoting appropriate breastfeeding practices is through the use of local peer counsellors to provide information and to support to mothers. odds ratio [OR] 3·45. p<0·0001)”. In unpublished work. CI-B has conducted a pilot study to examine the impact of this approach in a lower socio-economic population in urban Dhaka.[3] A recent meta-analysis of individual peer counselling for the promotion of exclusive breastfeeding found that the odds of exclusive breastfeeding in mothers receiving the counselling was “substantially increased in the neonatal period (15 studies.

001). The potential intensity and duration of the intervention is likely to result in a reduced rate of malnutrition and will be of great interest to public health planners in developing countries. These results suggest that. Outcomes and Significance Importance of the problem: Poor nutritional status of children is a major public health problem throughout the developing world and is the underlying cause for 35% of child deaths and 11% of the total global disease burden.005). In the intervention group 73% of mothers gave rice gruel to their children at six months compared to 60% mothers in the control area (p<0. and 2) Rice + lentil+ soybean oil (Khichuri. The proportions of the mothers who continue to give khichuri remained significantly higher in the intervention group compared with control at 12 months (26. The rate of exclusive breast feeding was 69% in the intervention area compared with only 6% in the control area at six months. However. Significantly more mothers used bottle to give complementary feeds in the control area compared with intervention area (43% Vs 14. 54%. Potential significance of the research: To date there have been no interventions that include peercounselling to improve infant feeding practices over the first 18 months of life. p<0.003). The results demonstrate the feasibility of implementing the intervention in an urban population in Bangladesh with evidence of changed feeding behaviours. 1) Rice gruel + soybean oil.5% for control and intervention groups respectively. These complementary food recipes were selected based on formative research that examined the types of foods being given to young children in urban Dhaka and were modified to increase their energy content. Khichuri was given by 18% mothers in the intervention area compared with 9% mothers in the control area (p<0. p<0.001). It is expected that the . Similarly. peer counsellors can improve infant feeding practices by increasing exclusive breastfeeding and appropriate complementary feeds.8% vs. p< 001). Planned outcome of the research plan: The proposed research will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh.additional training on complementary feeding and in particular on how to promote two types of complementary foods. the proportions of mothers who gave complementary feeds by spoon was significantly higher in intervention area compared with control (88% vs. The impact of this intervention on child malnutrition needs to be examined.[1] Developing effective and sustainable interventions to improve infant feeding will be integral components of efforts to reach the child survival and malnutrition Millennium Development Goals. 13%. there were no significant differences in the proportions of mothers giving rice gruel diet during this period. Two hundred and seventy-nine mothers in the intervention area and 277 mothers in the control area (without peer counsellors) were followed up until their infants were 12-month age.

publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited. .

a cohort of mother-infant dyads. or environmental) as an investigation tool to achieve the specific aims. The peer counseling education intervention will be delivered to the mothers.[7] The trial will be conducted in a total of 50 community clusters (Mallahas – smallest geographic units in Dhaka –see details below in Sampling Scheme). Outcome assessments will be conducted with all the mother-infant pairs recruited in the community clusters in the study. Experimental design a. The peer counseling education will be offered to eligible pregnant women identified by household surveys over 3 months in each community cluster in the intervention group. child growth and reduce the prevalence of malnutrition in their children. Discuss the alternative methods that are available and justify the use of the method proposed in the study. The outcome assessments will be made on a cohort of infant-mother dyads measured at baseline and at follow up visits because we expect a likely high correlation between baseline and follow up outcome measures. or social questionnaires relating to individual privacy. Two of these assessments (when infant is 15 and 18 months of age) will be made after the education intervention has ceased to assess the sustained impacts on the prevalence of child stunting and infant feeding practices (see evaluation plan for details). thus making this approach the most efficient study design. Study design We will use a community-based CRCT to examine the impact of a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery. social. Discuss the limitations and difficulties of the proposed procedures and sufficiently justify the use of them. starting in the third trimester of pregnancy until the child is one year of age. Justify the scientific validity of the methodological approach (biomedical. use of isotopes or any other hazardous materials. Discuss the ethical issues related to biomedical and social research for employing special procedures. There will be a baseline assessment and further assessments every 3 months from birth until the children are 18 months of age. will be identified in the control clusters.Research Design and Methods Describe in detail the methods and procedures to be used in accomplishing the objectives and specific aims of the project. Point out safety procedures to be observed for protection of individuals during any situations or materials that may be injurious to human health. 18 . This will result in two study groups (see diagram). who will receive standard maternal and child health care programs. to improve child feeding practices. The methodology section should be sufficiently descriptive to allow the reviewers to make valid and unambiguous assessment of the project. such as invasive procedures in sick children. Using a similar approach to recruitment. with 25 clusters in each study group. with an expected total of 1950 mother-infant dyads (975 in each treatment group). by locally recruited and trained peer counsellors. 1.

This is the best comparative design for the proposed interventions. 6. 9 & 1 mnh 2 ot s -t r I p c emma t As e s e t s s mns o i f nsa f na t t 1 & 1 mnh 2 8 ot s Lne ogr -t r I p c emma t o i f nsa f na t t 1 & 1 mnh 2 8 ot s -t r I p c emma t Po r m r ga s Pe er 19 . RANDOMIZATION PROCEDURE: I e tf d ni y i Mp r n i u r 5 ei i l ‘ a al s 0 l gbe Mh l a ” . which cannot be delivered to individual mothers in densely populated urban slum communities to avoid contamination of the intervention.In this CRCT the interventions will be allocated at a community level. A four year study is required to ensure an adequate “dose of the intervention” is delivered to the mothers in the intervention group. 6. Bn ad s a gl e h Rn o i ai n a d m to z b “ a al s y Mh l a ” P e c u s l i gi f n e r o n el n na t f e i ge u ai n e dn d c to pu l s Uu l M H r ga s s a C po r m Uu l M H r ga s s a C po r m Rcut e to e r i mn f pe n n mt es r g a t oh r Rcut e to e r i mn f pe n n mt es r g a t oh r Cn e t osn Cn e t osn Bs l n a ei e a s s mn ses e t Bs l n a ei e a s s mn ses e t Cu s li g o n el n Uu l M H sa C Uu l M H sa C S ot hr Lne ogr E u ai n d c to Po r m r ga s A ses e t s s mns A ses e t s s mns o i f nsa f na t t 3. 9 & 1 mnh 2 ot s S ot hr -t r I p c emma t As e s e t s s mns o i f nsa f na t t 3. but the outcome assessments will be at the individual level. and to give time to evaluate the longer-term impact of the interventions. Da a hk .

000 (according to the Census 2001. At present there are no infant feeding promotion programs run by the government health services in this area. The Dhaka Metropolitan City Corporation will be contacted in person to obtain their written approval for the study before the “Mahallas” are allocated to a treatment group or trial recruitment of subjects begins. The unit of randomization for the trial will be Mahallas.000 population during a specified time period”. The list of these Mahallas is available from the Dhaka Metropolitan City Corporation.[6] The 2004 Bangladesh DHS reported a current CBR for urban Bangladesh of 25. Sampling scheme The proposed field area for the study is Mirpur. which will form the sampling frame for selecting the clusters in the trial. Thus the average expected number of births for each Mahallas over a 3 month period would be 150.580. Any such programs will be identified by contacting local officials in the Ward Councils in Mirpur.bd/HT/M_0260. Mirpur has 16 “Wards” which are the smallest urban administrative unit each of which has a local government authority called a “Ward Council”. 20 . Recruitment and inclusion/exclusion criteria for clusters Source: http: //banglapedia.000 people.000 people. On average there are five “Mahallas” per “Ward” with an average population of 70.b. In Mirpur there will be a total of 80 Mahallas. although it may have increased by a further 20% to 30% since then). an “auxiliary Thana” in the Dhaka Metropolitan City Corporation with a total population of 5. Assignment of treatments The interventions will be assigned to eligible “Mallahas” using a fixed randomisation scheme with uniform allocation ratio of treatments. and blocks of 5 or 10 to ensure geographic balance across Mirpur area. The random allocation sequence will be generated using SAS® software. d. The definition of the “crude birth rate (CBR) is the number of births per 1. Below the “Wards” are "Mahallas" which are the lowest urban geographic unit with identifiable boundaries.search.com. which would be more than the required recruitment number for the trial and ensuring the feasibility of the sampling scheme for the trial. The average population of a “Ward” is 350. c.htm “Mallahas” on the sampling frame will be eligible for the study if they do not have any other infant feeding interventions currently being implemented either from the government of non-government sectors.8 per 1000 population for 3 years prior to survey.

Recruitment. out migration the required sample size comes to 456 in each group to have a 0.80.9 Taking 95 (round up the figure) and multiplying by 4 to reduce the cluster effect the sample size become 380.4 for each group and using formula.3 per 1000 total population over 6 months [based on CBR for urban Bangladesh of 25. Based on experience with similar projects in Bangladesh[3. Mother-infants pairs will also be excluded where there are multiple births.e. n= P1(100-p1) + P2 (100-p2)/(P2-P1)2 x 7. It is also likely that up to 30% will be excluded mainly related to their desire to migrate back to their home village after the delivery.000 and an expected crude birth rate of 4.8/1000 population over 36 months from 2004 Bangladesh DHS[6]] thus giving an average expected number of births of 150 over a 3 month period per Mahalla cluster.05 significance and with a power of 0. Pregnant women will be included who are 16 to 35 years with no more than three living children. congenital abnormalities. inclusion/exclusion criteria and consent of mothers and their families A previously successful approach to recruitment[3] will be used in which trained field assistants will identify women who are in their third trimester of pregnancy by systematic door-to-door surveys across the “Mahallas” over a 3 month period. Women who plan to migrate from the Mirpur area after delivery will be excluded. • Each community-cluster (Mahalla) has an average population of 70. 21 .[3] Sample Size Calculation and Outcome (Primary and Secondary) Variable(s) The sample size for the trial was estimated with the following assumptions: Sample size calculation for increasing the rates of exclusive breastfeeding in the intervention group • Considering the rate of EBF 43% in the control clusters (BDHS 2007) and the expected rate of EBF about 63% i. an increase of 20% in the intervention group the required sample size will be 92.5 kg or infant admitted to a neonatal intensive care unit. tuberculosis.8] it is expected that at least 95% of the mothers will consent to participate. Also women with documented medical records of heart disease. gestational diabetes or eclampsia in previous pregnancies will be excluded. very low birthweight below 1. Calculating a 20% drop out.e.

11] Facilities Available Describe the availability of physical facilities at site of conduction of the study. and it is likely to be sustainable in the future.[10] The sample size required would be 1950 mother-infant pairs (975 in each treatment group) from 50 Mallahas clusters with 39 mother-infant dyads per community cluster recruited over 3 months[7.015 [based on analyses of the child anthropometric measurements from the 2004 Bangladesh DHS survey data for urban child populations. population. which is similar to the change reported in an earlier education intervention for young child feeding in Peru. (b).[6]. • 39 mother-infant dyads per Mahalla cluster assuming 95% participation but 22% loss to follow-up based on earlier research. For field studies. thus leaving an expected number of eligible births of 200 over a 6 month period per Mahalla cluster. a.] • Expected difference in the prevalence of stunting between the treatment groups of 10% (35% in control to 25% in intervention group). describe the field area including its size. Manpower Administrative infra-structure Expertise (d). For clinical and laboratory-based studies. (a). and means of communications. • • 90% power and 5% two-sided alpha Intra-cluster correlation coefficient (ICC) of 0. Identify the laboratory facilities and major equipment that will be required for the study. the interventions will be delivered to the women starting in pregnancy and until their child is one year of age over the second and third years of the study. After one year of preparations for the trial. Anthropometric equipment's Intervention plan The trial intervention has been selected because its feasibility has been tested in urban populations in Dhaka. indicate the provision of hospital and other types of adequate patient care and laboratory support services.• Previous research[3] indicates that appropriately 33% of pregnant women will return to their home village following the delivery. (c).[3] from the approximately 200 mother-infant dyads available in each cluster over a 6 month period. Description of intervention 22 . The proposed individual peer counseling education will be of sufficient intensity to alter infant and young child feeding practices and to improve the growth of the young children and prevent malnutrition.

The main messages will be directed at encouraging early initiation of breastfeeding. The training will be given for 40-h (4-h daily for 10 days).a. and three monthly visits at age 9 and 12 months. The duration of each visit will be from 20 to 40 minutes. assessing the position and attachment of babies during breastfeeding. and ensuring an adequate frequency of feeds and diversity of foods used in their preparation. 23 . Counseling skills will be taught mainly by demonstrations and role play and will include: listening to mothers. five monthly visits from age 2 to 6 months. The counselors will also be taught how to use locally available foods for complementary feeding of infants and young children. Sample Size and Power for details) 100 peer counselors (four in each community cluster) will need to be recruited and trained. ii) Counselling schedules: There will be a schedule of at least 13 visits by the peer counsellors: two before delivery. It is anticipated that each peer counselor will be able to support up to approximately 10 mothers and thus to provide support to the approximately 1000 women receiving the intervention (see section 4. During the training course antenatal and postpartum counseling will be practiced with pregnant women.g. i) Selection and training of peer counsellors Women with personal breastfeeding experience. The counsellors will be free to make additional visits if the mother’s circumstances require them. giving support and providing relevant information and practical help when required. and motivated to work will be selected to become peer counselors. at least 6 years of schooling. The counselling will take place at home to ensure key family members (e. learning about their difficulties. and how best to demonstrate these food preparation skills to mothers. four during the first month. which has already been validated in a previous study[3] will be used for training of peer counselors. promoting exclusive breastfeeding during the first 6 months of life. building mother’s confidence. local women from the mothers’ community. residing in the same area. The WHO/UNICEF Breastfeeding Counseling Course adopted to the local language and culture. mothers with newborns and infants aged 1-12 months in the field site.The approach to promoting appropriate infant and young child feeding will be through a program of home-based peer counselling by trained. The performance of the counselors will be monitored at least four times during the course of the study by the Senior Infant Feeding Counselors. This approach will reach mothers who deliver at home and will also allow the messages to reach other key family members who may play a role in supporting breastfeeding and influence the foods choices for the infant. mother-in-law and fathers) can also be included in the counselling sessions. promoting appropriate timing of the introduction of complementary feeds.

the importance of complementary feeding. The mothers will be encouraged to continue breastfeeding and support will be given for an adequate frequency of complementary feeds and an appropriate diversity foods. Specific problems will be addressed and continued support for exclusive breastfeeding will be provided especially how to deal with family pressures to introduce other foods and concerns about the adequacy of the growth of the infant. There will be further demonstrations of the preparation of complementary feeds as needed. The two types of complementary feeds to be promoted are based on prior survey of foods given to young children in urban Dhaka. Mothers will be given measuring cups and spoons and two types of complementary foods will be demonstrated. They will encourage the mothers to eat more of their usual foods to support enhanced lactation.Antenatal visits: The peer counsellors during the two antenatal contacts will prepare the mothers. These meetings will also cover problems with breastfeeding that the mother might encounter and how best to deal with them. Visits from 6 to 12 months of life: The mothers will be contacted twice at 3 month intervals by the peer counsellors. From 5 months of age specific messages that include. problems with attachment tot eh breast. demonstration and preparation of complementary foods will be introduced. and other members of the family who will support her at delivery. family pressure to start other foods and mothers’ doubts about the adequacy of their Breastmilk. The first will be “ricesuzi” (powdered rice + soybean oil to make it energy dense). Visits in the first month of life: The mothers will be contacted four times by the peer counsellors (within 48 hours of delivery. about the importance of holding the baby within a few minutes of delivery and how to initiate breastfeeding within one hour of delivery. at 10-14 days and at 24-28 days). Issues that could be covered include sore nipples. the baby’s position during feeds. Mothers will also be discouraged from using bottles for feeding. Visits 2 to 6 months of life: The mothers will be contacted monthly by the peer counsellors. 24 . At these visits exclusive breastfeeding will be encouraged and the mother’s specific needs addressed. and to appropriately rest during the third trimester. If any of these issues could not be resolved the mothers could be referred to the Senior Infant Feeding Counsellors. They will discourage prelacteal feeds and other fluids and foods after lactation has been initiated. at 5-7 days. and the second will be “Khichri” (cooked rice + lentil + soybean oil).

b. . carbohydrate.  Changes in percentage of children at 6 & 9 months who receive solid. representatives of the Bangladesh Breastfeeding Foundation. Outcome assessment i) Key trial outcomes  Differences in the percentage of stunted infants (height-for-age <-2 Z) at 6. representatives of mothers’ groups from the community. 3.   Changes in mean duration of any breastfeeding. 12 and 18 months. 12. Evaluation plan a. Management of interventions There will be two senior infant feeding counsellors who will train the peer counsellors under supervisor of CI-B. ii) Measurements 1. 12. other relevant NGOs and project staff will help guide the research team and will meet every 3 months as the project progresses. Anthropometry: 25 . fat and selected micronutrients from complementary feeds at 9. local government officials. Changes in the percentage of women bottle feeding (any liquid or semi-solid food from a bottle with nipple/teat) their infants at 9 and 12 months. 15 and 18 months.  Changes in the mean intake of food energy. 15 & 18 months. To facilitate the overall implementation process. semi-solid or soft foods. an advisory committee consisting of a local health officers. protein.  Changes in percentage of children consuming foods from >4 food groups at 9. These senior counsellors will provide technical support to the peer counsellors and help them resolve problems they encounter during the implementation of the trial interventions by regular meetings with peer counsellors in the field.   Changes in mean height-for age Z scores from birth till 18 months Changes in the percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 3 and 6 months. There will be 10 field supervisors who will support the day-to-day logistics and administration of the field activities including support for the senior infant feeding counsellors when they are in the field and the per counsellors.

ear discharge.Trained research assistants will collect anthropometric measurements (weight and height) using established methods[9] and will record these measurements on both the research instruments and an infant growth chart for the mother to hold. These measurements will be standardised before and during the data collection. Ten percent of the interviewer’s scheduled visits will be monitored by one of the Senior Research Assistants or Principal Investigators or Investigators. dysentery (blood and/or mucus). Diarrhoea will be defined as an episode of the passage of three or more loose or watery stools within 24 hours. 12. ear infection (purulent discharge) from ears will be obtained at 3. 15 and 18 months). Mother’s reported infant feeding practice will be verified by a 4-hour observation period that will take place by unscheduled visits by Senior Research Assistants or Principal Investigators or Investigators. 3. The questionnaires will be checked daily. wasting (weight-for-height <-2 Z) and underweight (weight-for-age <-2 Z). and if the information is incomplete or not clear. the supervisor will return to the home on the next day to complete the data form. use of bottles for feeding and information about who is providing advice about infant feeding amongst family and friends. timing of introduction of other liquids or solid foods. 9. The 2006 WHO Growth Standard will be used to construct anthropometric indices and standard WHO recommended indicators will be used to assess stunting (Height-for-age <-2 Z). 2. fever and cough. current use of other liquids and solid foods. These will include questions about current breastfeeding status. 6 and 12 and 18 months using 2-weeks’ recall method. Presence of blood with stool will be defined as invasive 26 The questions asked will be based on the standard DHS infant morbidity recall questions but expanded to include questions about . 6. Infant and maternal morbidity Infant Morbidity Illness histories such as diarrhoea. Infant feeding practices: Standard questions about infant feeding practices used in the Bangladesh DHS surveys[6] will be used to monitor these patterns at the 3 monthly data collection periods from birth till 18 months of age. Anthropometry will be collected soon after birth and at 3 month intervals (3..

Recipes used to prepare foods will be recorded including the amounts of raw food used and the preparation methods. it will be called persistent diarrhoea. They will be asked to recall. urinary discomfort and fever). The total number of restricted days and the number of restricted days with fever will be used in analyses of their relationship with feeding practises. continuation of BF. The foods will be coded by the research assistants and nutrient calculated in special purpose programs using the Bangladesh Food Composition Tables. When a single episode of diarrhea lasts for more than two weeks. A medical history will be collected at baseline to capture information about maternal chronic illnesses as well. If maternal morbidity is equally distributed across the treatment groups we would not expect that this factor would bias the trial results. 5. EBF. Dietary intake: Trained interviewers will collect 24-hr dietary recalls using standard methods starting at 6 months of age till 18 months.diarrhea. Focus group discussion: A Focus Group Discussion (FGD) is an unique method of qualitative research that tries to find the views of people in a group through an interactive way. diarrhoea. Acute respiratory illnesses will be define as an episode of cough with reported fast and rapid breathing or difficulty breathing with or without fever. TIBF. any days they were ill enough to have their usual daily activities restricted. If they have experienced restricted day illness they will be asked about key symptoms (cough. Duplicate 24 hour recalls will be taken in a 10% subsample of respondents to assess within person variability and to allow adjustment of the prevalence of low intake nutrients. 4. over the month preceding the interview. FGD will be conducted with the mothers to learn about their perception and practices on child feeding and dietary pattern. 27 . All the foods consumed in the 24 hours prior to interview will be recorded and portion sizes measured in local utensils. Maternal morbidity A simple recall method will be used to assess morbidity in the mothers. FGD will be focus on – (1) Perception on Colostrum. Both nutrient intakes and food groups consumed will be analyzed and presented. and complementary feeding.

(3) Perception. and terms. who will record all answers in several broad categories. iii) Schedule of data collection 1. causes. the implementation of the intervention and the evaluation instruments and field methods before commencing the trial. Sabrina Rashid an anthropologist has been included in the study team (as consultant) who has expertise in qualitative data analysis. Each FGD will consist of 6 to 8 participants. EBF. Assessment of trial outcomes: A baseline survey at enrollment will be used to collect basic socio-demographic information about the family and the maternal characteristics. 2) File sorting and 3) Rating. and complementary feeding. and will be held at a location and time. The details of the birth and pregnancy will be recorded shortly after delivery. The FGD will be conducted over 2 hours for each group. A statistical program ATLAS ti will be used for qualitative data analysis which will use 1) Free listing. The group facilitator will be assisted by research personnel. (5) Perception on disease. (6) Beliefs about appropriate types of complementary feeding The FGDs will be conducted with mothers in 6 groups from the intervention areas and 6 groups from the control areas from randomly selected communities. (4) The perceptions on food security of children like complementary feeding practice and pattern and adequacy of breast feeding. The data from the focus groups will be analyzed to extract essential issues 28 . possible consequences of malnutrition from mothers that they experience in their day to day life. Dr. which is convenient for the group. The qualitative answers will then be transformed into quantitative expression. These include anthropometry. The trial outcomes will be assessed by a series of measurements taken at 3 monthly intervals from birth until 18 months of age. continuation of BF.(2) Constraints to feeding colostrum. A pilot study will be conducted in the first year of the study in a single cluster to test the recruitment methods. services taken during illness. recording of dietary patterns and dietary intake. She will also record the session using cassette player for later transcription and translation. A trained Field Research Officer will facilitate the session. 2.

A quality control team will retain the survey team. which may be shared with respondent or the guardian if requested. will visit the survey sites and re-interview and re-examine a randomly selected 2% of the respondents interviewed over the preceding 15 days.b. If gross errors are found. Quality Control of the study: A major responsibility of ICDDR. The benefits of the investigation should outweigh the risks. The team will observe onsite interviews and anthropometric measurements of the under-2. The field staff will be advised to maintain all information/ data confidential. dose. and by focus groups at the end of the intervention year. B. The contractor will not have right to retain a copy of data set in case the part of the study is contracted out.B. Safety monitoring is defined as any process during clinical trails that involves the review of accumulated outcome data for groups of patients to determine if any treatment procedure practiced should be altered or not.B would be to ensure quality and authenticity of data generated from the study. The monitoring plan should commensurate with risk. B. Data will be kept confidential and following their collection will be accessible to only the investigators and Ethical Review Committee of ICDDR. 29 . reach and intensity of interventions: i) Participation of mothers in peer counselling sessions ii) Self report adherence to peer counselling guidelines by the peer counsellors iii) Unscheduled observations of the peer counsellors at home visits iv) Focus groups & open ended questions with mothers & peer counsellors about the program This data will be collected during the implementation of the interventions. if necessary. respective staff will be removed. Discrepancies noted during external validation will be resolved in discussion with the survey agency. Process assessment is needed to examine the fidelity. The Independent Quality Control Team (IQCT). a) b) c) d) All investigations require monitoring. the following should be kept in mind. and Monitoring should be with the size and complexity of the investigation. comprising of representatives of ICDDR. All data will remain the property of ICDDR. and their analyses. Data will be coded at the level of computer entry. Data Safety Monitoring Plan (DSMP) All clinical investigations (biomedical and behavioural intervention research protocols) should include the Data and Safety Monitoring Plan (DSMP) to provide the overall framework for the research protocol’s data and safety monitoring. It is not necessary that the DSMP covers all possible aspects of each element. When designing an appropriate DSMP.

and data may be shared only with respective respondent or participating parents/ primary caregivers’ if requested. Data will not carry the name of the participants and instead codes will be entered onto computer.Data Safety: Data will be kept confidential and will not be available to anybody except the investigators. 30 . Data collecting personnel will be advised and motivated to keep the information confidential.

Time line for survey study Months of studies Works to be ac co m pl is he d 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Approval Screening for target population/Study set-up/Mapping Recruitment & Training Pilot study Enrolment. Intervention & Monitoring Follow up Data Collection Data Entry 31 .

Data analysis Report writing 32 .

Secondary analyses will examine each outcome variable (stunting. feeding patterns. height-forage Z) and generalized linear mixed models for non-continuous outcomes (e.g. We will use linear mixed models for continuous outcomes (e.g. Matrix. TX. but will be adjusted for the community-cluster randomization. Model assumptions will be checked and appropriate adjustments to the analysis will be made where necessary. adjusted for clustering. For clinical trials.1 (2008.Data Analysis Describe plans for data analysis. Analyses will be conducted at the mother-infant dyad level. Statements about various important issues. Quantitative Data analysis plan: Data analysis will be by intention to treat.g. percentage exclusively breastfeeding). logistic mixed models for binary outcomes e. and community-cluster as a random effect to account for the cluster effect. The models will be able to evaluate the impact of the interventions over time by testing for an interaction between time and intervention group. with xtmixed command to fit linear mixed models and xtmelogit command to fit mixed-effects models for binary outcomes/responses. All qualitative data will be summarized and a detailed report will be presented. diagram and flow chart will be presented as the reason /origin (both socio-economical) behind peer counselling. height-for-age. STATA® software version 10. indicate if interim data analysis will be required to determine further course of the study. Attitude and Practice). Indicate whether data will be analysed by the investigators themselves or by other professionals. Models will include treatment group as a fixed effect. reduced and coded according to the qualitative data analysis method (Applied Health Research Manual: Anthropology of Health & Medical Care). BCC (Behaviour Change Communication) among the parents/ primary caregivers of participating children. Analysis of qualitative data: Data collected from the focus group discussion and observation will be ordered. when the code will be opened. and mean nutrient intakes) taking account of the repeated measurements within children by using separate mixed models. Analyses will be conducted to identify the baseline characteristics of mother-infant dyads who may benefit most from the intervention. USA) will be used for all analyses. College Station.[12] The primary analyses will compare the prevalence of stunting (height-for-age < -2 Z) in children at 24 months of age using Pearson’s chi-square tests and 95% confidence intervals for the group difference. Emphasis will be given on changes in KAP (Knowledge. Specify what statistical software packages will be used and if the study is blinded. infants as a random effect to account for the repeated measurements. exclusive 33 . We will report the results for 2-sided 5% tests for the primary trial outcome. Stata Corporation.

et al. malaria. Lancet 371: 243-260. Allen LH. If the study needs observations on sick individuals. Literature Cited Identify all cited references to published literature in the text by number in parentheses. and its methods. 2003 Jun. Caulfield LE. pneumonia. (2008) Maternal and child undernutrition: global and regional exposures and health consequences.1647. risks and benefits. Indicate how participants rights will be protected. Black RE. Blossner M. Ethical Assurance for Protection of Human Rights Describe the justifications for conducting this research in human participants. Bhutta ZA. 3. Huttly S (2000) Effect of community-based peer counsellors on exclusive breastfeeding practices in Dhaka. 4. however. This study doesn’t involve use of any animal. continuation of breastfeeding. and measles. as well as the voluntary nature of participation and the rights to withdraw from the study without any penalty or prejudice.breastfeeding. malnutrition. Kabir I. and confidential handling of personal information. Written informed consent will be obtained from patients/ primary caregivers of respective children after explaining to them the purpose of the study.[see comment]. Lancet 356: 1643 . References 1. Bangladesh: a randomised controlled trial [see commments]. Food & Nutrition Bulletin 24: 5-28. de Onis M. 34 . Haider R. provide sufficient reasons for using them. Am J Clin Nutr 80: 193-198.[erratum appears in Food Nutr Bull. exercise judgment in assessing the “standard” length. There is no page limit for this section. 2. de Onis M. List all cited references sequentially as they appear in the text. complementary feeding. For unpublished references. Dewey KG. and if there would be benefit or risk to each participants of the study. Caulfield LE. Ashworth A. Black RE (2004) Undernutrition as an underlying cause of child deaths associated with diarrhea. failure to improve nutritional status by the study subjects. Use of Animals Describe if and the type and species of animals to be used in the study. provide complete information in the text and do not include them in the list of Literature Cited. Justify with reasons the use of particular animal species in the experiment and the compliance of the animal ethical guidelines for conducting the proposed procedures.24(2):239]. Brown KH (2003) Update on technical issues concerning complementary feeding of young children in developing countries and implications for intervention programs.

(2005) Effectiveness of an educational intervention delivered through the health services to improve nutrition in young children: a cluster-randomised controlled trial. Also describe what type of publication is anticipated: working papers. Lancet 371: 417-440. 12. Cousens S. Mitra and Associates. Bhutta ZA. and the mechanism to be used. Comput Biol Med 34: 113-125.178 p. or programmatic arrangements with other national or international organizations or individuals. 11. Results will also be published in international peer-reviewed journal(s) for sharing with larger scientific community. identifying them if known. The results of this study will be shared with the government of Bangladesh. et al. National Institute of Population Research and Training (NIPORT). 10. Klar N (2000) Design and analysis of cluster randomization trials in health research. p. Describe if and how the research findings would be shared with stakeholder. Lohman TG. workshops etc. Pediatrics 108: E67. Indicate the nature and extent of collaboration and include a letter of agreement between the applicant or his/her organization and the collaborating organization. Donner A. Maryland [USA]: National Institute of Population Research and Training. Collaborative Arrangements Briefly describe if this study involves any scientific. internal (institutional) publication. Mitra and Associates. Bangladesh and Calverton. 9. administrative. (2001) Exclusive breastfeeding reduces acute respiratory infection and diarrhea deaths among infants in Dhaka slums. x.B’s and national and international seminars.. London: Arnold. 35 . Arifeen S. Ahmed T. fiscal. New York: Oxford University Press 190-211 p. Creed-Kanashiro HM. Martorell R (1991) Anthropometric Standardization Reference Manual. Grimshaw JM (2004) Sample size calculator for cluster randomized trials. Black R. Dissemination and Use of Findings Describe explicitly the plans for disseminating the accomplished results. Macro. Penny ME. international publications. 8. 7. Robert RC. Black RE. 6.[see comment]. and will be disseminated at ICDDR. Dhaka. Caulfield L. international conferences and agencies. MacLennan GS. Caulfield LE. Indicate. O (2005) Bangladesh Demographic and Health Survey 2004. Thomson S. Roche AF. Baqui A. Antelman G. Narro MR. Ramsay CR. and ORC Macro. Dewey K.5. Campbell MK. if the project is linked to the Government of the People’s Republic of Bangladesh through a training programme or a collaborative arrangement. et al. Champaign: A Division of Human Kinetics Publishers. (2008) What works? Interventions for maternal and child undernutrition and survival. et al. Murray DM (1998) Design and Analysis of Group-Randomized Trials. Lancet 365: 1863-1872.

Cleveland. however.D.0 List of ongoing research protocols (start and end dates.M. and percentage of time) 4. ICDDR. Head (Previuosly)./1986. Use a photocopy of this page for each investigator. USA Gastroenterology & Clin Nutr Ph. be submitted in the format as convenient to them) Biography of the Investigators Give biographical data in the following table for key personnel including the Principal Investigator.This trial will conduct by the investigators collaboratively. however. Clinical Sciences Division. (Note: Biography of the external Investigators may.K./1992.B 3 Educational background: MBBS /1975 Dhaka Medical College. Dhaka University in nutrition (last degree and diploma & training relevant to the present research proposal) 4. be submitted in the format as convenient to them) 1 Name: A. (Note: Biography of the external Investigators may. Clinical Unit C. Breastfeeding Counselling Service and Research Unit. As Co-Principal Investigator Protocol Number             Starting date             End date             Percentage of time             36 . Iqbal Kabir 2 Present Position: Scientist & Coordinator. M.D. Use a photocopy of this page for each investigator. Case Western Reserve University.1. As Principal Investigator Protocol Number 2008053 01211733 (BC)             Starting date 01-08-08 15-09-07             End date 01-08-10 29-06-10             Percentage of time 30% 20%             4.2. One of the Principal investigators is from the University of Sydney and there are also two more Investigators from The University of Western Sydney and the Queensland University of Technology Biography of the Investigators Give biographical data in the following table for key personnel including the Principal Investigator.

3. J Nutr 2009. Arifeen SE. Dibley 37 . Kabir I. e. Grander M. 6 Five recent publications including publications relevant to the present research protocol 1) Enneroth H. Hussain MB. Persson LA. scaling up of exclusive breastfeeding. Bhandari N. 116: 963-69. Frongillo EA. Persson LA. Kabir I. Kabir AKMI. Name: Michael J. annotations. Am J Clin Nutr 2007. 1. c. Lonnerdal B. Kunstl L.                                                4. Salam MA.85:1075-82. Kabir I: Association between breastfeeding pattern and diarrhoeal and respiratory illness: a cohort study in Chittagong. and abstracts in peer-reviewed journals Working papers Monographs Numbers 91 4 30 70 b. As Co-Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         5 Publications a. Duration of exclusive breastfeeding and infant iron and zinc status in rural Bangladesh. Matern Child Nutr 2008. Kabir I. Mainstreaming nutrition in maternal and child health program. Types of publications Original scientific papers in peer-review journals Peer reviewed articles and book chapters Papers in conference proceedings Letters. Apr 4(supple 1): 5-23. Wright A. 139: 1562-1567. Goessler W. Bangladesh. El Arifeen S. Vahter M. Nov 24 (3): 283) Fangstrom B. Int Breastfeeding J 2008. d. Barbo N. Oddy WH. Mander AP. Environ Health Perspect 2008. Moore S. Fulford AJC. Prentice AM. 4) 5) Moore SE. editorials. Arifeeen SE. 2) Mihrshahi S. Coward WA. Peat JK. Ekstrom EC. Breast-feeding protects against arsenic exposure in Bangladeshi infants. Palm B. Use of stable-isotope techniques to validate infant feeding practices reported by Bangladeshi women receiving breastfeeding counseling. f.

Cambridge University and Institute for Child Health. Atlanta. annotations. As Co-Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         5 Publications Types of publications g. As Co-Principal Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         4. The University of Sydney.A. NSW Australia 3 Educational background: (last degree and diploma & training relevant to the present research proposal) Master of Public Health. Peer reviewed articles and book chapters i. As Principal Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         4. and abstracts in peer-reviewed journals k. University of London       4. Original scientific papers in peer-review journals h. 1988. Papers in conference proceedings j.School of Public Health.0 List of ongoing research protocols (start and end dates.4.S.5. editorials. and percentage of time) 4. 1982. Dunn Nutrition Unit.6. U.2 Present Position: Associate Professor in International Public Health School of Public Health. Emory University . Letters. Working papers l. Monographs Numbers 85 1 14 64 18       38 . Epidemiology Postgraduate Training in Nutrition in Health and Disease. GA.

Garg M.J. Public Health Nutrition.K.J. Sibbritt D. Reproducibility and comparative validity of a food frequency questionnaire for Australian children and adolescents. M. Use a photocopy of this page for each investigator.. T. Biotechnology & poverty 2008 1987-1990 1984 . Nutrition. doi: 10.. Agho KE.J. be submitted in the format as convenient to them) 1 2 3 Name: Dr. BMC Public Health.. Collins C.1186/1479-5868-6-62 Cheng Y...L. September 2009.H.. K. 9:222. Assessment of dietary intake among pregnant women in a rural area of western China. Dibley M.W.. Roy Present Position: Senior Scientist Educational background: (last degree and diploma & training relevant to the present research proposal) FRCP Ph. International Journal of Behavioral Nutrition and Physical Activity 2009. Vietnam. N. (Note: Biography of the external Investigators may.. and Dibley MJ. Zhang X.W. D. Dibley M.. pp.1017/S136898000999125X Biography of the Investigators Give biographical data in the following table for key personnel including the Principal Investigator. Zeng L. Dibley. 41 (7). 2009 July 9. Medicine and Science in Sports and Exercise 2009. Prevalence and risk factors for stunting and severe stunting among under-fives in North Maluku province of Indonesia Submitted to BMC Public Health accepted August 2009. Sibbritt. M.1985 University of London London School of Hygiene and Tropical Medicine.. Validity and reliability of an FFQ for use with adolescents in Ho Chi Minh City..E.. Hong. Dibley. D. Trang. PMID: 19589154 2) 3) Ramli. T. Factors associated with physical inactivity in adolescents in Ho Chi Minh City. 6:62 doi:10.J. Inder KJ. however. Bowe SJ. Yan H..D in Nutrition Certificate on Food. S. 1374-1383 4) 5) Hong. UK & UNU 39 . Jacobs J.F.H. Sibbritt.6 Five recent publications including publications relevant to the present research protocol 1) 1) Watson J.K. Vietnam.W.D.

Working papers r. UK Dhaka Medical College.9. and percentage of time) 4.7. Papers in conference proceedings p. Monographs Numbers 65 9 36 6 Five recent publications including publications relevant to the present research protocol 40 . University of Dhaka 4. As Co-Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         5 Publications Types of publications m. and abstracts in peer-reviewed journals q. annotations.8.M. editorials. As Co-Principal Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         4. Peer reviewed articles and book chapters o. Original scientific papers in peer-review journals n.0 List of ongoing research protocols (start and end dates.Sc. in Human Nutrition MBBS 1983-1984 1973 London School of Hygiene and Tropical Medicine. Letters. As Principal Investigator Protocol Number 2006-45 2008-003 PR-09014       Starting date 1st February 2007 15 May 2008 1st October 2009       End date 30 November 2007 10 months after approval 30 September 2010       Percentage of time 4.

Shafique S. 375-383. KE Islam. W Khatun. Mahmud Z. G Ara. Impact of Zinc supplementation on subsequent morbidity and growth in Bangladeshi children with persistent diarrhoea.1. Roy SK. Use a photocopy of this page for each investigator. Chakraborty B. Food and Nutrition Bulletin. AM Tomkins. Chakraborty B. EJCN March 2007. SM Akrauzzman. 2006 2. Shafique S. Sack DA.Khatun. Chowdhury R. be submitted in the format as convenient to them) 1 2 Name: Seema MIHRSHAHI Present Position: October 2009 Heinz Postdoctoral Research Fellow Institute of Biomedical Innovation (IHBI) School of Public Health Queensland University of Technology Kelvin Grove 4059 Australia 3 Educational background: (last degree and diploma & training relevant to the present research proposal) Masters in Public Health. Muneer SME. and Roy S. Chakraborty B. 1-7 4. 2007 International Health Thesis topic: Exclusive breastfeeding and child morbidity in developing countries 41 . MPH Treatise: Effectiveness of allergen avoidance in infancy PhD. vol 28 (4). Nutrition Foundation of India. Hossain M. Begum A. Roy SK. Roy SK. Azim T. J Health Popul Nutr 2007 Mar. Chowdhury R. Zinc supplementation in children in cholera in Bangladesh: Randomised controlled trial. 1999 Coursework & treatise: International Health/Disease Prevention. Curtin University of Technology. Azim T. Jolly S P.J. Synergistic effect of vitamin A and zinc on nutritional status and growth in 6-36 months age group. Raqib R. Prevention of malnutrition among young children in rural Bangladesh by a food–healthcare educational intervention: A randomized controlled trial. Fuchs G J. University of Sydney. Raqib R. W. (Note: Biography of the external Investigators may. Roy SK. Biography of the Investigators Give biographical data in the following table for key personnel including the Principal Investigator. Khatun W. BMJ January 2008: online publication. Chowdhury S. In: proceedings of the symposium on Nutrition in late infancy and early childhood (6-24 months). Fuchs GJ. Roy S K.25(1):67-74 3. S P Jolly. Khatun W. Khanam M. January 2008. Zinc supplementation in the management of shigellosis in malnourished children in Bangladesh. 5. however.

12. Tien NT. annotations.4. and percentage of time) 4. BMC Public Health. Letters.11. Papers in conference proceedings d. Biggs BA. 2009. and abstracts in peer-reviewed journals e. Working papers f. Mihrshahi S. Phuc TQ. editorials. 42 .9:261. Macgregor L. Peer reviewed articles and book chapters c. Montresor A. Monographs Numbers 26 3 39 39 6 Five recent publications including publications relevant to the present research protocol 1) Casey GJ. As Principal Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         4.0 List of ongoing research protocols (start and end dates. Thach TD. As Co-Principal Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         4.10. Original scientific papers in peer-review journals b. A free weekly iron-folic acid supplementation and regular deworming program is associated with improved hemoglobin and iron status indicators in Vietnamese women. As Co-Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         5 Publications Types of publications a.

Int J Parasitol.3:28. Shuaib M. Hector D. Exp. CAPS Team. Oddy W. 5)Mihrshahi S. Ichikawa N. Peat JK. 2007. Oddy WH. 37(5):671-9. Bangladesh. Kemp AS. Phuc TQ.2) Mihrshahi S. Marks GB. Thach DT. Webb K.39(9):1037-43. Clin. 24. (Note: Biography of the external Investigators may. Kabir AKMI. School of Medicine The University of Western Sydney. Biggs BA. Kabir I. The effectiveness of 4 monthly albendazole treatment in the reduction of soil-transmitted helminth infections in women of reproductive age in Viet Nam. Casey GJ. The association between infant feeding practices and subsequent atopy among children with a family history of asthma. and Peat JK Prevalence of exclusive breastfeeding in Bangladesh and association with diarrhoea and acute respiratory infection: results of the Multiple Indicator Cluster Survey (MICS). 2009.25(2):195-204. Use a photocopy of this page for each investigator. 3) Mihrshahi S. Dibley MJ. Journal of Health. Tien NT. Int Breastfeed J. University of Technology. Montresor A. Population and Nutrition 2007. 2008. Almqvist C. Association between infant feeding patterns and diarrhoeal and respiratory illness: A cohort study in Chittagong. and percentage of time) 4. Australia.0 List of ongoing research protocols (start and end dates. (last degree and diploma & training Sydney       relevant to the present research proposal) 4. 4)Mihrshahi S. be submitted in the format as convenient to them) 1 Name: Kingsley Emwinyore Agho 2 Present Position: Research Fellow in Biostatistics. 3 Educational background: Doctor of Philosophy. Allergy. Ampon R. however. Ampon R.13. Biography of the Investigators Give biographical data in the following table for key personnel including the Principal Investigator. As Principal Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         43 .

Journal of Public Health Nutrition 2007 10(10):996-1004. Dibley. MJ. Papers in conference proceedings v. Statistics and Probability Letters. Bowe SJ. 2) Titaley.. J: Empirical Saddlepoint Approximations of the Studentized ratio and Regression Estimates for Finite Population. 4) Senarath. Agho. K: Breastfeeding practices index: a composite index to describe overall breastfeeding performance among infant under 6 months of age. editorials. Jacobs J and Dibley MJ: Prevalence and risk factors for stunting and severe stunting among under-fives in North Maluku province of Indonesia. Working papers x. 71 (3): 237–247. annotations. 2005.15. K. K. As Co-Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         5 Publications Types of publications s. Dibley. R: Factors associated with Hb concentration among Timor-Leste children aged 6-59 months. BMC Pediatrics 2009.. 2008 Jul 9. 5) Agho. Population and Nutrition 2008 26 (2):200-9. 9 (1):64. Dibley. CL and Hall. Monographs Numbers 35      4      13      2      2      1      6 Five recent publications including publications relevant to the present research protocol 1) Ramli. Agho K. BMC Public Health. Dai. MJ & Agho.14.8(1):232. W & Robinson. U. K. Original scientific papers in peer-review journals t. Inder K. C and Gibberd. 3) Agho. J: Determinants of Neonatal Mortality in Indonesia. and abstracts in peer-reviewed journals w. D’Este. Journal of Health. As Co-Principal Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         4.. Letters... Peer reviewed articles and book chapters u.. MJ. CR. Roberts. 44 .4.

As Co-Principal Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         4.17.18. As Principal Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         4. (Note: Biography of the external Investigators may.0 List of ongoing research protocols 4. Papers in conference proceedings Numbers 3 1 45 .Biography of the Investigators Give biographical data in the following table for key personnel including the Principal Investigator. Bangladesh (ICDDR. Original scientific papers in peer-review journals z. HSID. International Centre for Diarrhoeal Disease Research. As Co-Investigator Protocol Number                         Starting date                         End date                         Percentage of time                         5 Publications Types of publications y. Research Investigator Health system and economics unit. 3 Educational background: M. and percentage of time) 4. however.B.B. B).S 1994 (start and end dates. be submitted in the format as convenient to them) 1 Name: ANADIL ALAM 2 Present Position:. Peer reviewed articles and book chapters aa. Use a photocopy of this page for each investigator.16.

training of staff. Joseph Das. Khairun Nessa. Sexually Transmitted Diseases.1. 13-19 2. actual conduct of the survey. major equipment. Mohsina Huq. p. and laboratory services. Monir Uddin Badal. Shama-A-Waris. and abstracts in peer-reviewed journals cc.32. Khairun Nessa. Shayema Khursheed. Excepted in the Journal of STD and AIDS Budget Justifications Please provide one page statement justifying the budgeted amount for each major item. Robert F Brieman. Najmul Hossain and Motiur Rahman. including the use of human resources. Faisal Arif Hasan Chawdhury. Saifur Rahman. monitoring of quality and progress. Co-Principal Investigators: The co-principal investigator will help in the design. annotations. Sexually Transmitted Diseases. Monographs 2 6 Five recent publications including publications relevant to the present research protocol 1. One of them will lead the QC data collection in the field 46 . Emily Gurley. data analysis and report writing. Shirajum Monira. editorials. Kazi Faisal Mahmud. Field evaluation of simple rapid tests in the diagnosis of syphilis. Vol. Dipak Kumar Mitra. Zafar Sultan. Working papers dd. PI: Will spent 25% of time and be responsible for overall design. (2004) Sexually transmitted infections (STIs) among brothel-based Sex Workers (SWs) in Bangladesh: high prevalence of asymptomatic infection. Shamsun Nahar. Faisal Arif Hasan Chawdhury. Jinath Sultana. Anadil Alam. Mohsina Huq. Motiur Rahman. quality control. Shamsun Nahar. Anadil Alam. Gazi Salauddin. Letters. Jan 2005. No.bb. and in data analyses and report writing. checking at least 5% data in the field. defending the proposal at institutional review committees. training. coordination with relevant persons and departments.

Statisticians/ Data Analyst: The Statistician/Data analyst will supervise Data Management Assistant and assign daily tasks to data entry staff. S/he will provide required support to the scientific staff, and assuring quality output on a regular basis as planned. Program Manager: One full time senior manager is needed to keep track of progress in all sectors and coordination of such a large survey work. S/he will organize work schedules, ensures logistics support, manages financial transaction, supervise for QC in field team coordination, training in QC, questionnaire development and conducting workshops, process and analyze data collected from field surveys, make literature search of relevant researches, liaison in organization of work within office and other offices, check data entry cleaning & prepare analytical tables and figures. Research Officer: S/he will work full time to organize work schedules, participates and supervises and coordinates QC field teams gives training in QC, organizes questionnaire development, field testing process and analyze data collected from field surveys, literature search , organization of work within office, check data entry, cleaning & draft data tables and figures. Data Management Assistant: S/he will organize data entry activity with reference to data collection procedures, prepare documentation of data files with code plan, ensure data file backup on a regular basis. S/he will prepare code plans, edit plans, carry out consistency checks, and ensure daily/weekly data backup. Will also assist analysis of data. Office Attendant: S/he will assists the Project Office Management Team to provide its day-to-day logistics support services i.e xerox needs, carrying supplies, handles different office machines e.g. xerox machine, spiral binder, etc., keep offices clean and in order. S/he will be responsible to arrange the meeting/seminar rooms and keeps materials in its places as per plan arrange logistics for meetings and to respond all other meeting needs i.e. photocopying, switch adjustments, or transporting overhead/power point etc. Secretary: Secretary will prepare documents and help tying and liaison with departments for HR issues and smooth supply and procurement, prepare and organize documents for staff and field related communication. Keep records for financial transactions and follow up communications and decisions. Field research Officer: The post holder is responsible to supervise the activities to maintain the quality of service and data collection. S/he is responsible to identify the training need of the staff and conduct/organize training. S/he is responsible to review the field activities and prepare report.
47

The position holder is needed to edit the collected data independently and ensure completion, consistency and accuracy of the collected data. S/he is responsible for field administration, managing leave, checking the bills etc. The position holder is responsible to maintain liaison with the community and senior staff of the project. Field Research Assistant: S/he will carry out fieldwork independently or jointly for collecting data at a satisfactory quality. S/he will be, responsible for editing, coding and crosschecking of the data in the field.

Other Support
Describe sources, amount, duration, and grant number of all other research funding currently granted to PI or under consideration.
     

48

Check-List
CHECK-LIST FOR SUBMISSION OF RESEARCH PROTOCOL FOR CONSIDERATION OF RESEARCH REVIEW COMMITTEE (RRC) [Please check (X) appropriate box]
1. Has the proposal been reviewed, discussed and cleared at the Division level? Yes If No, please clarify the reasons:       2. Has the proposal been peer-reviewed externally? Yes No No

If the answer is ‘No’, please explain the reasons:       If yes, have the external reviews’ comments and their responses been attached Yes 3. No

Has the budget been cleared by Finance Department? Yes No

If the answer is ‘No’, reasons thereof be indicated:       4. Does the study involve any procedure employing hazardous materials, or equipments? Yes If ‘Yes’, fill the necessary form. 5. Has the Ethics Certificate(s) been attached with the Protocol? Yes No No

If the answer is ‘No’, please explain the reasons:      

_______________________________ Signature of the Principal Investigator

_________ Date

49

5(c) and 7. Describe consent procedures to be followed including how and where informed consent will be obtained. Describe and assess any potential risks – physical. organs. legal or other. c) If there is a potential risk to the participant or privacy of the individual might be affected while applying any particular procedure include a statement in the consent form to clarify whether or not compensation and/or treatment will be available. Include a description of the methods for safeguarding confidentiality and protecting anonymity. and state the approximate length of the interview. If research methods are anticipated to create potential risks. Describe the requirements for a study population and explain the rationale for using in this special population groups such as children. and assess their likelihood and seriousness. tissues. When there are potential risks to the subject. death or other). State if the activity requires the use of records (hospital. explain why this requirement should be waived and provide an alternative procedure that would be used.3. 50 . 8. If an item is not applicable. or the privacy of the individual may be affected. The statement to the potential participants should include information specified in item 2. or groups whose ability to give voluntary informed consents might be compromised. Assess the potential benefits to be gained or risk the individual participants might be subjected to. if any. a) If signed consent will not be obtained.4. The abstract should summarise the purpose of the study. If study involves an interview. 6. birth. 3. the methods and procedures to be used. please note accordingly: 1. and also the benefits that might accrue to the society in general as a result of the planned work. Clarify if and how the benefits outweigh the risks. provide justification for this course of action. the foetus or the abortus. 7. b) If information is to be withheld from a subject. informed consent must be obtained from their parents or legal guardians. social. which were considered and why they will not be used. 2. describe the place and processes. and also indicate the approximate time they would be required to remain in the activity. the investigators are required to obtain a signed informed consent from the prospective participant.For minors and individuals with compromised ability to provide a valid consent. psychological. 4. describe alternate methods. by addressing each of the following items. 5.INFORMATION TO INCLUDE IN ABSTRACT SUMMARY The Ethical Review Committee will not consider any application that does not include an abstract summary. body fluids. medical. Describe procedures for protecting against or minimizing potential risks and an assessment of their likely effectiveness.

M.3 51 . Iqbal Kabir PR#10001 CSD National Health & Medical Research Council (NHMRC). Australia Total: Au$_912. K. A.488 From:_2010_ through__2014 1.5 & 3.Detailed Budget for the study titled: Name of Principal Investigator: Protocol Number: Division: Funding Source: Budget: Study period: Strategic Priority Code(s): Details Budget: Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh Dr.

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et al. 2009 2 Roy SK. Thus we think our estimates for attrition are reasonable. Interestingly this systematic review found a smaller growth response from home micronutrient fortification (sprinkles or crushable tablets) than education interventions. We welcome the opportunity to respond to the Assessors’ questions below. However we would be more concerned about compromised validity of the trial if the attrition rate was much higher then 20% to 25%. We realize that the description of the complementary feeds that would be promoted by the peer counselors lacked sufficient detail and we have expanded this in the section on modifications to the protocol below. We agree with the assessment that the significant innovation in our proposal is the extension of a peer-counseling approach to integrate all the key infant and young child feeding messages in a single program of support and promotion of appropriate feeding from pregnancy through the first of life. We would also use mobile phones to Minimat Study conducted in Matlab where there were 2 counseling sessions during pregnancy. et al. the evidence indicates that food-based interventions are able to deliver these nutrients even in poor communities provided adequate knowledge. 28 (4): January 2008: 375-383. Lancet 371: 417-440. In Bhutta ZA. Presented at Pediatric Academic Societies meeting in Baltimore. How to deal with attrition and will it be higher than 22%? (Assessor 1 & 3) We would have no difficulty with expanding the sample size if we found a higher attrition rate in the pilot study than was assumed when calculating the sample size. We have therefore modified the proposal to expand the peer counselor contacts with mothers to monthly visits until nine months (see description below). However less frequent peer counselor contacts with mothers have been used in other research projects conducted by CIB and yet resulted in an adequate response1. (2008) What works? Interventions for maternal and child undernutrition and survival. then 5 more until the baby was six months old and this resulted in an exclusive breast feeding rate of 50% in the BF counseling group compared to only 27% in the control group.APPLICANT RESPONSE Application ID: 633229 We thank the Assessors for their positive review of our proposed cluster randomized controlled trial of peer counseling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh. There is strong evidence from a systematic review that education interventions about appropriate complementary feeding do improve child growth3 . Food and Nutrition Bulletin. 1 63 . encouragement and support is available in the community. and found it was only 23%. Will 13 peer counsellor visits will be sufficient to achieve the outcomes? (Assessor 1) We understand the concern of the assessor in questioning the intensity of the intervention if the number of peer counselor visits is reduced from the earlier trial in which only breastfeeding was promoted. The approach we will use has been previously evaluated by CIE and found to result in significant impact on growth2. The rationale for our use of a food-based intervention was to ensure that both the energy density and micronutrient content of the complementary feeds would be improved in a sustainable way. We carefully considered the number of contacts when designing the trial because we wanted to test an intervention that was replicable and sustainable in the future and thus we restricted the total number of contacts. 3 Dewey K et al Web Appendix 3 Systematic review of the efficacy & effectiveness of complementary feeding interventions in developing countries. We will therefore actively engage the cohort of mothers by regular group meetings to talk about the study and identify any problems they may be experiencing. However we plan to train the counselors to be flexible and to increase their contacts if the mother needs additional support (or the reverse if mother needed less support). May 2-5. We have calculated the subject attrition rate from birth till the infant was 12 months of age for the pilot study described in the research plan. Micronutrients and complementary feeding interventions (Assessor 2) We agree with the comment by Assessor 2 that adequate micronutrient intake is required for appropriate child growth. Although we think that multiple micronutrients are needed for adequate growth.

Although phone. Contamination – can it be reduced and monitored? (Assessor 1) Contamination of the intervention into the control group population is always an important concern of investigators conducting community-based health promotion trials. These approaches could be used for both the control and intervention groups. Strategies to reduce contamination. Data management. pp58 in Hayes RJ. travel. Chapman & Hall/CRC 2009 4 64 . It is not possible to equitably conduct international collaborative research without the participation of in-country partners in the data analysis and this is the rationale for their visits to Australia in year four of the project. We will map each Mahalla and divide it into a central zone with 75% of the households from where the women for the trial will be recruited. monitoring the quality of data collection. Cluster Randomised Trials. thus effectively creating a buffer zone4 to reduce contamination. Why three monthly follow-up? What cost savings and trade-offs would be involved in reducing the frequency of follow-up? (Assessor 1) Reducing the follow up frequency is unlikely to result in substantial cost savings especially if it was limited to just two follow up visits at 9 and 15 months. CIA has done this in cross cultural settings (relative to his Anglo-Australian background) including in Indonesia. China. quality control systems & data transfer across countries (Assessor 1 & 2) CIA has had substantial experience is setting up data management systems for international field trials. We think that the risk of contamination is low because the social networks are weaker in urban populations. email and internet connections will also be important to support effective management of the project.B have had prior experience in using these systems. CIB and CIC have all had experience in either directly managing or facilitating large scale epidemiological studies that involve multidisciplinary teams and require active engagement of government and non-government stakeholders. Each Mahalla is approximately 1 Km2 and has over 2000 to 3000 households. especially for CIB & CIE to visit Australia in YR 4 (Assessor 1) International collaborative research requires cross country contact to be successful. establish the data entry. A web-based data entry system would be used and both research groups at the University of Sydney and ICDDR. CIB and CIC have worked closely with BRAC a large NGO in Bangladesh on both research and development projects. He also has strong links with key government and NGO stakeholders and his networks will greatly facilitate the implementation of the project. data cleaning and monitoring processes. CIE brings important experience in developing and putting into operation an intervention study on complementary feeding.keep in contact with families. establishing project management systems. and we would collect multiple family contacts at the start of the trial to ensure we had more than one avenue to search for the participants if needed for follow up assessments. The allocation of 10% effort for this project is sufficient for these tasks which do not overlap with the more intensive field work required of CIB. conceptualizing analysis plans and conducting analyses. The risk would be more missing data and less data to describe longitudinal changes in growth. CIs’ experience leading large scale epidemiological studies (Assessor 1) CIA. Any lower level of effort would risk compromising the implementation of the study interventions and the quality of the evaluation data. Justification of the time fractions requested for CIB and CIE (Assessor 1) CIB will allocate 50% effort for managing the field trial. This level of effort is essential to ensure a successful outcome in any complex community based trial where daily supervision and monitoring of staff and activities is required. Moulton LH. Justification for int. Vietnam and India. face-to-face contact is essential when developing research instruments. Appropriateness of dietary assessment methods (Assessor 2) Design Issues. He would work with the data manager (PRP4) and CIB and CID to prepare manuals of operations.

The ICDDR. despite the large burden of disease from child malnutrition in the region. She will work closely with the team during the development of the intervention.D. The best long term indicator of improved nutrition and health is stunting and this has been widely used in evaluations of infant feeding interventions3.The proposed dietary assessment methods are appropriate because the analysis will examine the group means for each treatment group. Competitive position of the research group relative to other international nutrition/health groups working in South Asia (Assessor 2) All the CIs have worked together as part of the South Asian Infant Feeding Research Network (SAIFRN) which was established by CIA to address the lack of research being conducted in South Asia on infant and young child feeding. She is social scientist and nutritionist with an interest in the social processes influencing family decisions about infant feeding. Social and Behavioral Sciences Unit. mashed vegetables including green leafy vegetables. Underweight (low weight for age) is influenced both by linear growth as well wasting. and with the training of the peer counsellors. Modifications to the proposal in response assessor questions or comments The following items have been added to the proposal in response to points raised by the assessors. Stunting (low height for age) is currently the best measure for assessing the cumulative deficient growth associated with longterm dietary insufficiency and recurrent illness. and report all three indicators (underweight. Our research team is internationally competitive and has conceptualized an innovative research project that can potentially provide important evidence to guide nutrition programs in South Asia. Justify why adverse events are not being monitored (Assessor 2) We will not have sufficient statistical power to examine the effect of the intervention on child mortality. ICDDR. Why the focus on stunting rather that underweight? (Assessor 3) We plan to measure weight and height. Description of complementary feeds to be promoted by peer counselors The two types of complementary feeds to be promoted are based on prior survey of foods given to young children in urban Dhaka. Team make-up (Assessor 3) The team could benefit from further diversity and we have reached an agreement to work collaboratively with Sabrina Rasheed Ph. and wasting) since they measure and reflect different aspects of child malnutrition.B is one of the global leaders in research on child nutrition and health in developing countries and does not need to be benched marked against US universities. Child morbidity will be balanced across treatment groups by randomization. Mothers will also be discouraged from using bottles for feeding 65 . and the second will be “Khichri” (cooked rice + lentil + soybean oil). For both traditional feeds the mothers will be encouraged to add animal protein. stunting. Intervention schedule The peer counseling contacts will be monthly from 2 until 9 months. and some seasonal fruits to improve the micronutrient diversity of the feeds. The first will be “rice-suzi” (powdered rice + soybean oil to make it energy dense). Assistant Scientist. . The close contact required might result in a non-specific study effect as a consequence of the close contact required that would reduce the differences between the treatment groups. CIA was faculty of the Department of International Health at the Johns Hopkins University for seven years and has close professional relationships with their international nutrition staff.B. The JHU staff have focused their research on micronutrient interventions which are being conducted in Nepal and Bangladesh and not on infant and child feeding interventions. Its composite nature complicates its interpretation. Wasting (low weight for height) indicates in most cases recent acute weight loss from food shortage or an acute severe disease. Measurement of morbidity would add considerable complexity and costs tot eh trial.

A.K.Diversifying the team We have added Dr Sabrina Rasheed. M. a health social scientist with an interest in infant and young child feeding. Iqbal Kabir 66 . Ethics Certificate of Dr.

S.Ethics Certificate of Dr. K. Roy 67 .

Ethics Certificate of Dr. Anadil Alam 68 .

Consent Form (18-45) 69 .

B Purpose of the research Poor nutritional status of children is a major public health problem throughout the developing world and is the underlying cause for 54% of child deaths and 11% of the total global disease burden. Appropriate IYCF have been found to reduce one fifth of child death and prevent malnutrition. 70 . A. current use of other liquids and solid foods.Protocol Number: _10001___________________________________________________________ Protocol Title: Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh Investigator’s name: Dr. The potential intensity and duration of the intervention is likely to result in a reduced rate of malnutrition and will be of great interest to public health planners in developing countries. We will also measure his/her weight and height as well as mid upper arm circumference and measure your child food which your will eat within 24 hours. child growth and reduce the prevalence of malnutrition in their children. timing of introduction of other liquids or solid foods. It is expected that the publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited. Why are we inviting you to participate in the study? We are inviting you to participate in this study because your cooperation to the study may help to promote appropriate breastfeeding and complementary feeding can improve feeding practices. M. current breastfeeding status. Iqbal Kabir Organization: _ICDDR. collect 24-hr dietary recalls that your child usually take within 24 hours. use of bottles for feeding and information about who is providing advice about infant feeding amongst family and friends. we will ask you some questions about socio- economic status. K. To date there have been no interventions that include peer-counselling to improve infant feeding practices over the first 18 months of life. What is expected from the participants of the research study? If you agree to our proposal of enrolling you in the study. The completion of all processes may need about one hour of your time.

Privacy. RA. you would continue to receive the standard care and treatment of the Dhaka Hospital of ICDDR. ICDDR. which may harm you. anonymity and confidentiality We will keep all of your information strictly confidential. We will not be able to give you any compensation for participation in this study. Dr. the research will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh. Mohakhali. Salam. If you help in this study by giving some time. If you do not participate and if you withdraw your participation after initial enrolment.B that protects the interest of research participants will have an access to your information. You would also be able to withdraw your consent at any time during the study period. You will also be able to contact the principal investigator of this research study. You may also decide not to respond to any or all questions that we will ask you. If you want to know more about your rights as a participant in a research study or related issues you may contact Mr. Manager. Iqbal Kabir. or about our study.Risk and benefits There is no risk from participating in this study involving any procedure.B. In fact. you may ask us now or in future. Right not to participate and withdraw Your participation in this study is absolutely voluntary i. If you have any question regarding your health aspects. at the Dhaka Hospital of ICDDR. Principle of compensation Your participation in this study is absolutely voluntary. If you wish we will inform you any results of your own. IRB Secretariat. the module of peer counselling intervention program will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh. and none other than the staff of our study and the Ethical Review Committee of ICDDR. M. Dhaka-1212 personally or 71 . Future use of information If the results are found as anticipated.B. A. Mohakhali.B in future. Dhaka-1212 personally or communicate him over telephone 8860523-32 (extension number 2312)) or Mobile phone No:01730095515.e. you may know more about your nutritional status and related information if you ask us. you are the one to decide for and against participation.

Salam Khan. RA. she/he shall put her/his full name and designation and then sign) (Name and contact phone of IRB Secretariat. phone: 9886498 or PABX 8860523-32 ext. 3206). If you agree to our proposal of enrolling you/your patient in our study. please indicate that by putting your signature or your left thumb impression at the specified space below Thank you for your cooperation _______________________________________ Signature or left thumb impression of subject ____________________ Date _______________________________________ Signature or left thumb impression of attendant/Guardian _______________________________________ Signature or left thumb impression of the witness ____________________ Date ____________________ Date _______________________________________ Signature of the PI or his/her representative ___________________ Date (NOTE: In case of representative of the PI.communicate with him at the following telephone number: 8860523-32 (extension number 3206) or direct: +880-2-9886498. M. A. Consent Form (Bangla) (18-45 years) 72 .

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Iqbal Kabir Organization: ICDDR. To date there have been no interventions that include peer-counselling to improve infant feeding practices over the first 18 months of life. 75 . `¯—LZ) { KwgwU m¤^š^q †m‡µUvixi bvg I †dvb bv¤^vi :Gg G mvjvg Lvb. †dvb 9666498(WvB‡i±). Appropriate IYCF have been found to reduce one fifth of child death and prevent malnutrition. The potential intensity and duration of the intervention is likely to result in a reduced rate of malnutrition and will be of great interest to public health planners in developing countries.M.AskMÖnYKvixi mv‡_ AvMZ AwffveK `¯—LZ ev Av½y‡ji Qvc ÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑ ÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑ mv¶vrKvi MªnYKvixi `¯—LZ ÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑ ÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑÑ cÖavb M‡el‡Ki `¯—LZ ZvwiL ZvwiL ZvwiL (‡Kvb Kvi‡b cÖavb M‡elK Abycw¯’Z _vK‡j Zvi cÖwZwbwai bvg . K.G·3206} Assent Form (15-17 years) Protocol Number: 10001 Protocol Title: Peer counselling to improve feeding practices and reduce malnutrition in children 0-2 years in Bangladesh Investigator’s name: Dr. It is expected that the publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited. A. wcGweG· 8860523-32.B Purpose of the research Poor nutritional status of children is a major public health problem throughout the developing world and is the underlying cause for 54% of child deaths and 11% of the total global disease burden.

timing of introduction of other liquids or solid foods. In fact. Future use of information If the results are found as anticipated. which may harm you. If you wish we will inform you any results of your own. What is expected from the participants of the research study? If you agree to our proposal of enrolling you in the study. anonymity and confidentiality We will keep all of your information strictly confidential. the research will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh. and none other than the staff of our study and the Ethical Review Committee of ICDDR. child growth and reduce the prevalence of malnutrition in their children. you may know more about your nutritional status and related information if you ask us. current breastfeeding status. use of bottles for feeding and information about who is providing advice about infant feeding amongst family and friends.Why are we inviting you to participate in the study? We are inviting you to participate in this study because your cooperation to the study may help to promote appropriate breastfeeding and complementary feeding can improve feeding practices. If you help in this study by giving some time. current use of other liquids and solid foods. we will ask you some questions about socio- economic status. the module of peer counselling intervention program will provide high level evidence of the efficacy of peer counselling to support appropriate breastfeeding and complementary feeding practices and reduce malnutrition in young children in urban Bangladesh. Privacy. Risk and benefits There is no risk from participating in this study involving any procedure. The completion of all processes may need about one hour of your time. We will also measure his/her weight and height as well as mid upper arm circumference and measure your child food which your will eat within 24 hours.B that protects the interest of research participants will have an access to your information. collect 24-hr dietary recalls that your child usually take within 24 hours. Right not to participate and withdraw 76 .

You will also be able to contact the principal investigator of this research study. M. Principle of compensation Your participation in this study is absolutely voluntary. Dhaka-1212 personally or communicate him over telephone 8860523-32 (extension number 2312)) or Mobile phone No:01730095515. ICDDR. Dr. or about our study. A.B. If you agree to our proposal of enrolling you/your patient in our study. RA. Dhaka-1212 personally or communicate with him at the following telephone number: 8860523-32 (extension number 3206) or direct: +880-2-9886498. you are the one to decide for and against participation.B. If you want to know more about your rights as a participant in a research study or related issues you may contact Mr. If you have any question regarding your health aspects. If you do not participate and if you withdraw your participation after initial enrolment. Salam. Manager.B in future. you would continue to receive the standard care and treatment of the Dhaka Hospital of ICDDR. you may ask us now or in future. IRB Secretariat. please indicate that by putting your signature or your left thumb impression at the specified space below Thank you for your cooperation _______________________________________ Signature or left thumb impression of subject ____________________ Date _______________________________________ Signature or left thumb impression of attendant/Guardian _______________________________________ Signature or left thumb impression of the witness ____________________ Date ____________________ Date _______________________________________ Signature of the PI or his/her representative ___________________ Date 77 .e. Mohakhali. Mohakhali. You may also decide not to respond to any or all questions that we will ask you. We will not be able to give you any compensation for participation in this study.Your participation in this study is absolutely voluntary i. Iqbal Kabir. You would also be able to withdraw your consent at any time during the study period. at the Dhaka Hospital of ICDDR.

A. evsjv‡`k | M‡elYvi D‡Ïk¨:Ñ Dbœqbkxj †`‡ki g‡a¨ evsjv‡`‡ki wkï‡`i g‡a¨ Acywói e¨cKZvi nvi cÖej| cix¶vq ‡`Lv wM‡q‡Q ‡h h_vh_ AvBIqvBwZGd Øviv 1/5 wkï g„Zz¨ nvi K‡g‡Q Ges Acywó `~ixKi‡b ¸iyZ¡c~iY fywgKv iv‡L| 54% wkï g„Zz¨ Ges 11% wewfbœ ai‡bi Amy‡Li cÖavb Kvib GB Acywó| 18 gv‡mi wkï Lv`¨vfvm DbœZ Kivi Rb¨ eZ©gv‡b †Kvb ai‡bi civgk© Kvh©µg we‡kl K‡i mZx_© civgk© Pvjy †bB| civgk© Kvh©µ‡gi mydj Ges civgk© `v‡bi Dchy³ mgq Avgv‡`i †`‡ki Acywó `~ixKi‡b ¸iyZ¡c~iY fywgKv ivL‡e| Dbœqbkxj †`‡ki RbmsL¨v cwiKíbvKvix‡`i Rb¨ GwU GKwU AZ¨š— AvKl©bxq cwiKíbv n‡Z cv‡i| Avkv Kiv hvq GB M‡elbv n‡Z cªvß djvdj cÖKvwkZ n‡j wkï‡`i ¯^v†¯’¨i Dci ¸i“Z¡c~ib cÖfve †dj‡e| `w¶Y Gwkqvi wkï‡`i Rb¨ Rb¯^v¯’¨ I cywó welqK cwiKíbvi Dbœqb Kiv hv‡e. hvi Øviv wkï‡`i ¯^v‡¯’¨I DbœwZ‡Z e¨cK f~wgKv ivL‡e| ‡Kb GB M‡elYvq Aš—©fy³ nIqvi AvnŸvb Rvbv‡bv n‡”Q? 78 .†K. phone: 9886498 or PABX 8860523-32 ext. Assent Form (Bangla) (15-17 years) M‡elYvi b¤^i: 10001 M‡elYvi bvg: evsjv‡`‡ki 0-2 eQ‡ii wkï‡`i Lv`¨vf¨v‡mi Dbœqb Ges Acywó `~ixKi‡bi Rb¨ mZx_© civgk© `vb cÖÖavb M‡elK: W: G.(NOTE: In case of representative of the PI. RA. M.BKevj Kwei ms&¯’v: Avš—R©vwZK D`vivgq M‡elYv †K›`ª. Salam Khan. she/he shall put her/his full name and designation and then sign) (Name and contact phone of IRB Secretariat. 3206).Gg.

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PEER COUNSELLING TO IMPROVE FEEDING PRACTICES AND REDUCE MALNUTRITION IN CHILDREN 0-2 YEARS IN BANGLADESH QUESTIONNAIRE Principal investigator: Dr. B: Knowledge for Global Lifesaving Solution GPO Box. Mohakhali.128.K. M. Dhaka-1000. Bangladesh QUESTIONNAIRE-1 81 . Iqbal Kabir Scientist : Clinical Sciences Division ICDDR. A.

How many children do you have? __/ 7. How many people live in this house(household members) __/__/ (eating from the same pot at present) 9. Does your husband live in this house __/ 1 = no. __/ 4. 6= 82 . Interviewer code (1-6) ___/ 2. separated 2 = no. lives in city/abroad dead 4 = no. Date of interview __ /__/__/__/__/ Interviewer`s name : ASK MOTHER these questions What is your name? ______________ 6. ID no. Is this your 1st/2nd/3rd/4th/5th pregnancy? __/ 8.PREGNANCY DATA FORM (To be filled during 8th month of pregnancy) 1. __ /__/__/__/__/ 5. Block and house no. do any of the following family members live in this house. Section no. 2 = yes ) Your mother __/ Your husband`s mother __/ Your sister-in-law __/ Others (specify) __/ 3 = no. Besides your husband. has another wife 5 = yes comes and goes 10a. __/__/__/ 3. who can influence decisions about baby`s feeding (1 = no.

Have you had Tetanus Toxoid (TT) injections __/ 1 = no 2 = partial 3 = all complete ASK HUSBAND (as far as possible). go to Q. __/ Are you employed at present? 1 = no 2 = yes 3 = factory worker 6 = business Have you had any antenatal checkups (ANC) during this pregnancy 1 = no 2 = yes If no. __/ 17. __/ 11.the following questions: IF HUSBAND IS NOT AVAILABLE.16 14.18 16. __/__/ 12. ask mother to check with husband and inform 19. go to Q. __/__/ Religion of family What is your age (years) How many grades/classes have you studied (Q 13-21for SE status ) 13. What has been your occupation during current pregnancy __/ 1 = housewife 2 = maid 4 = office employee 5 = professional 7 = others ( specify ) If housewife. What is your (husband`s) occupation __/ 1 = unemployed 2 = farmer 3 = laborer (sk/unsk) 83 .Does any influential family member live in this union Specify who ___________________________ 10b. __/ How many ANC have you had so far? ANC where? 1 = FWC 3 = other clinic in union 5 = hospital (give name) 2 = satellite clinic 4 = other clinic elsewhere (name) 18. __/ 15.

/_/ Did you give (name) colostrums? 1 = no 2 = yes [Explain that colostrums is the thick. How old is s/he? (months) /_/_/ 24. what is the total family income /_/_/_/_/ If there is previous living child. a) what is your (husband`s) monthly income (in takas) /_ /_/_/_/_/ b)income of wife (if earning) /_/_/_/_/ 22. go to Q. ask MOTHER the following questions. How old was (name) when you started to give /_/_/ her/him plain water? (in days) Ask for complementary feeds 84 . yellowish secretion Produced from the breast in the first week of life] 26. /_/ Did you breastfeed (name)? 1 = no 2 = yes ________________________ 25. If not.35 What is the name of your youngest baby 23. 5 = driver 8 = business 6 = office employee 9 = other (specify) How many grades/classes have you ( husband) studied __/__/ 21.4 = rickshawpuller 7 = professional 20.

How old was (name) when you started to give this food (days)? /_/_/ 30.27. /_/ Why you did give this _______? 1 = insufficient milk 4 = for better growth restless/not sucking 7 = baby sick weak 2 = to accustom baby to other milk 5 = mother employed 3 = mother sick 6 = baby 8 = too much housework 9 = mother 31. /_/ Did you give him/her any additional food along with breast milk (not prelacteals) when s/he was a small baby (before 6 months) 1 = no 2 = yes If no go to Q. Did anyone advise you to start these (complementary ) feeds? (1 = no Mother /_/ Mother-in-law /_/ Friend/relative /_/ 2 = yes) 85 . ask Q. 28 28 /_/ What additional food did you start first? 1 = cow`s milk = banana 6 = others (specify) 2 = powder milk 3 = gruel 4 = rice 5 7 = don’t know/don’t remember 29.33 If yes.

bf duration & start of CF) 1 = no 2 = yes If no. if no.ask Q. go to Q.Doctor /_/ Nurse/midwife /_/ husband /_/ others(specify) /_/ 32. So what was (name)`s age when /_/_/ You stopped breastfeeding her/him (in days)? 35. how to breastfeed bf benefits.35. If “yes”.38.ask Q. go to Q. what? /_ /_/ ____________________________________________________________ _/ / 86 .34 34. /_/ Are you still breastfeeding her/him? 1 = no 2 = yes If answer is yes.36 36. Did you use a bottle to feed the baby at any time ? /_/ (esp within 6m) 1 = no 2 = yes 33.if yes . /_/ Have you heard any advice about infant feeding? (Prompt for ebf.

Do you plan to breastfeed the coming baby? /_/ ii). why not ? /_/ ____________________________________________________ 39. From whom did you hear this advice? Clinic staff (1 = no 2 = yes) /_/ mother /_/ m-in-law /_/ FP worker /_/ Friends/neighbors/relatives /_/ Media (radio and/ TV) /_/ Printed material /_/ Others (specify ) /_/ 38i). 1 = no 2 = yes 3 = don’t know 2 = yes 1 = no 2 = yes 3 = after 6= If yes. If no. How soon after delivery do you plan to start breastfeeding? /_/ 1 = within 1 hour 2 = after few hours milk flows out 4 = on 3rd day 5 = don’t know 40. ask what other fluids do you plan to give? 1 = no 87 ./_/ 37. /_/ Do you plan to give your baby anything else in The first 3-4 days? 41.

43 43a.honey /_/ misri water/suger water /_/ mustard oil & honey /_/ Plain water /_/ Mustard oil /_/ powder milk /_/ Fresh cow`s milk /_/ Other food (specify) /_/ 42.45 If yes. Some people say that breastfeeding helps to space pregnancies /_/ What do you think? 1 = disagree 2 = agree 3= don’t know 4 = not sure 88 . ask Q. When baby is----days old _/_/_/ 44. prompt for pill. inj) /_/_/ 1 = no 2 = combined pill 3 = prog only pill 4 = condom 5 = IUD 6 = inj 7 = ligation 8 = homeo 9 = kabiraj 10 = withdrawal 11 = safe period 12 = foam tablet 13 = Norplant 20 = combination of 2 or more methods (specify) 45. go to Q. condom. When do you plan to start (When baby is how old?-----days) On day of birth /_/ When periods start /_/ When husband comes back /_/ Don’t know /_/ 43b. Do you have a preferred method? (if necessary. /_/ Do you plan to use any family planning method after this baby 1 = no 2 = yes 3 = don’t know If no or don’t know.

/_/ Number of rooms Electricity 1 = no 2 = yes (Assets to be coded 1 = no 52. VCP /_/ 2 = yes 89 . Bed /_/ 53. Rickshaw /_/ 57. /_/ Type of house 1 = katcha 2 = semi pucca( brick with tin roof) 3 = pucca (brick and cement) 50. Radio /_/ 56. TV /_/ 58. Fridge /_/ 60. If “disagree” why? /_/ _________________________________________________________ 47. /_/ If “agree” why? _________________________________________________________ 48. And for how long does bf help space pregnancies (months) /_/_/ OBSERVATIONS + RELATED QUESTIONS (for SE status) 49.46. Sewing machine /_/ 59. /_/ 51. Table and chair /_/ 54. Fan present /_/ 55.

/_/ pucca Own house Type of latrine 1 = none 2 = common latrine katcha 3 = common latrine 4 = private latrine katcha 6 = common sanitary 63.61. /_/_/ Mother`s MUAC (cm) COMMENTS 90 . /_/ 62. /_/ 65. /_/ Water source for washing 2 = tubewell 5 = private latrine pucca 7 = private sanitary (flush) 1 = pond/river water (private) 64. /_/_/ 3 = piped water (common) 4 = piped Water source for drinking (code as above) Mother`s weight (kg) 66. Mother`s height (cm) _/_/_/_/ 67.

QUESTIONNAIRE-2 POST DELIVERY DATA Interviewer`s name Respondent: Mother________ or other _______ 1. Date of interview _/_/_/_/_/_/_/ 6. Where was the baby delivered? /_/ 1 = home 2 = hospital 9. Type of delivery section 1 = vaginal 3 = clinic 2 = caesarean /_/ 10. Block and house no. /_/_/_/_/_/ 5. _/_/_/ 3. Date of birth of baby (dt-mo-yr) /_/_/_/_/_/_/ Time of birth of baby (hours) /_/_/_/_/_/ 7. Interviewer code (1-6) /_/ 2. Mother`s reporting of gestation age (weeks) /_/_/ 8. Section no. ID no. Who delivered the baby /_/ 91 . _/_/ 4.

Why was this food given (code 1 = no For sweet voice /_/ To satisfy hunger /_/ To prevent cold. Baby born /_/ 0 = still birth 2 = untrained dai 6 = others specify 1 = singleton 1 = male 2 = twins/triplets 2= /_/ 12. Cardiac problems.17 17. anomalies eg. What problems Mother given antidepressants Baby was/is in intensive care /_/ Visible congenital anomalies such as cleft palate /_/ (babies with other cong. Down`s syndrome. cough /_/ To clean stomach. Gender of baby female 13. go to Q. mouth of throat /_/ To stop baby`s crying /_/ 2 = yes ) 2 = honey 3 = misri/sugar/glucose water 4 = honey+mustard /_/ 92 . Where there any problems after delivery (1 =no 2 = yes ) (write from hospital records in case of hospital delivery) /_/ 14. to be excluded when diagnosed) Other problems (specify) /_/ *For exclusion form study 15.1 = TBA (identify by kit box/bag with an organization logo) 3 = experienced relative 4 = nurse 5 = doctor 11. How soon after delivery did you hold the baby (hours) /_/_/ 16. What is the fast food given to the baby /_/ 1 = colostrums oil 5 =plain water 6 =mustard oil 7 = cow`s milk 8 = powder milk 9 = others If colostrums was given.

If yes .26. Was any other fluid/milk given in the first 3 days /_/ before colostrums /_/ 19. go to Q.21 onwards 21.Given traditionally /_/ Colostrum insufficient /_/ Mother sick /_/ Baby do not suckle /_/ Other reason (specify) /_/ 18. Was expressed breastmilk given? /_/ 22. /_/ Sugar/misri water /_/ Honey +mustard oil /_/ Plain water /_/ Mustard oil /_/ Cow`s milk /_/ Powder milk /_/ Other food /_/ 20.ask Q. Within how many hours after delivery did the baby first suckle from the breast /_/_/ 21a. /_/ Did you continue other (prelacteal) fluids/milk AFTER Giving colostrum 1 = no 2 = yes 93 . /_/ Have you given your baby colostrums as yet (definition as in Questionnaire 1) ( 1 = no 2 = yes ) What other food/fluids (prelacteals)were given? ( 1 = no Honey 2 = yes ) ( 1 = no 2 = yes ) If no.

or did you start yourself 1 = started myself 2 = dai 3 = baby`s maternal grand mother 4 = baby`s paternal grandmother 5 = nurse 6 = doctor 7 = PC 94 . Where these other feeds continued or given in addition to colostum (code 1 = no 2 = yes ) For sweet voice /_/ To satisfy hunger /_/ To prevent cold.what was it? Honey Sugar/misri water /_/ Honey +mustard oil /_/ Plain water /_/ Mustard oil /_/ Cow`s milk /_/ Powder milk /_/ Other food /_/ 25. After delivery. /_/ 24. /_/ Did you start new food (postlacteal)after giving colostrums? If new food started.23. cough /_/ To clean stomach. mouth of throat /_/ To stop baby`s crying /_/ Given traditionally /_/ Colostrum insufficient /_/ Mother sick /_/ Baby do not suckle /_/ Other reason (specify) /_/ 26. did anyone tell you /_/ When to start breast feeding.

Since sunrise yesterday till sunrise today. /_/ Did anyone actually help you to hold your baby correctly If “yes ’’ . but different bed 95 .who helped you? Dai/TBA baby`s maternal grandmother /_/ baby`s paternal grandmother /_/ nurse /_/ doctor /_/ PC /_/ Others /_/ 29. What have you fed the baby (Prompt for water and other food in addition to breastmilk) TOTAL colostrums honey sugar water honey+m. /_/ 31.oil plain water mustard oil cow`s milk powder milk other (specify) ____________ _____________ ___________ ________ ________ __________ ____________ _____________ Time Food Time Food NUMBER OF FEEDS ________ _______ _ ________ ________ ________ ________ ____ _____ _______ ________ ________ _________ _________ ________ ________ _____ ______ ________ ________ _____________ ____ _____ ________ ________ ________ ________ ________ ________ 30. /_/ 28. /_/ Did you use a bottle for feeding ? Where does the baby sleep at night 1 = same bed as mother 3 = different room 1 = no 2 = yes 2 = same room.27.

Baby`s length in cm (1st reading) /_/_/_/ 36. /_/ 33. Mother`s weight (kg) /_/_/_/ 37. baby`s weight in kg (2nd reading)* * (To be referred if wt <1800 g) 35. by whom? Baby`s maternal grandmother Baby`s paternal grandmother /_/ Baby`s aunt /_/ Servant /_/ Neighbor /_/ Other (specify) /_/ 34a. Feeding status /_/ OTHER EBSERVATIONS and COMMENTS /_/_/_/ 96 . /_/ If anyone helping with mother`s share of housework 1 = no 2 = yes If helped.32. Mother`s MUAC (cm) /_/_/_/ 38. baby`s weight in kg (1st reading)* /_/_/_/ b.

have you resumed paid work? 1 = at home 2 = resumed work /_/ 3 = planning to join PART 1 MORBIDITY Now I am going to ask you how_____(baby`s _name) was during the last 7 days. I will start by asking about the last 24h from sunrise yesterday to sunrise today-and then about the day before-then the previous day and so on. Block and House no. 4. /_/_/_/ 3. Did____ have symptoms or illness from sunrise yesterday until sunrise today: /_/ /_/ 97 . how has____been? 1 = not well 2 = well LAST 24 HRS (please fill boxes below) 9a). /_/_/ /_/_/_/_/_/ /_/_/_/_/_/ /_/_/ 5a. 9. ID no.From sunrise yesterday until sunrise today. Date of interview b.QUESTIONNAIRE 3 ( WEEKS) Interviewer name: 1a. Section no. how are you? 8. Do you stay at home all the time OR (if employed). Interviewer code 1-6 1b. Visit week no Ask mother. Respondent Mother ___/ Maternal GM___/ Paternal GM___/Aunt___/Others___/ 2.

how much did you spend on travel (takas)? /_/ d) How much did you spend on service/doctor/healer`s fees /_/_/_/_/_/ e) besides treatment and travel .12i If the baby HAD DIARRHOEA. but HAD COUGH OR FEVER. 4 = less /_/ 98 . (prompt for specific illness if not mentioned spontaneously ).11 (fill appropriate boxes) 11) ASK whether any TREATMENT was given (including ORT)& COST OF EACH ONE 1 = no treatment required 2 = ORS 3 = kabiraj med (herbal) 4 = homeopathic med 5 = local healer 6 = allopathic med 7=2+6 NO NAME CODE 11a.13 If the baby DID NOT have DIARRHOEA OR DYSENTERY. specify on what. 3 = not known (IF YES .did you spend anything else in connection with this illness ?(special food.1 = no.also CODE 2 = YES in past week for same illness) PAST WEEK (please fill boxes bellow) 10a). ORDYSENTERY. ASK Q._________ And how much /_/_/_/_/_/ f) during diarrhea. did you feed breast milk ? 1 = no. COST (taka ) 1 2 3 b) When _____ had diarrhea /dysentery. 3 = more. 2 = yes. did you go anywhere outside the home to get treatment for him/her? 1 =no 2 = yes /_/ c) If yes. DYSENTERY. Did _____have any other illness in the past week /_/ CODE 1 =no 2 = yes 3 = don’t know (IGNORING ANY WHICH HABE ALREADY BEEN MENTIONED AS PRESENT IN PAST 24 HRS)code 2 only if symptoms in the box are present NO b c d e SYMPTOM or ILLNESS Diarrhea Dysentery Cough fever PAST 24 HRS PAST WEEK If the baby DID NOT have DIARRHOEA. COUGH OR FEVER GO TO Q. GO TO Q. 2 = same. tips etc) If yes.

2 = yes ) IF NO. did you go anywhere outside the home to get treatment for him/her? 1 = no 2 = yes c) If yes. Since your last interview. COST (taka ) b) When _____ had cough and fever. how much did you spend on travel (takas)? /_/_/ /_/_/_/_/_/ d) How much did you spend on service/doctor/healer`s fees e) besides treatment and travel .did you spend anything else in connection with this illness ?(special food. has _____ had any illness for which s/he had to be taken to a health Facility/clinic/hospital or others for treatment? (1 = no._________ /_/_/_/_/_/ And how much For sever e illness 13.GO TO Q.B 5 = private clinic 6 = doctor`s chamber 7 = from pharmacy 8 = homeopath 9 = kabiraj/fakir/huzur 10 = allopath+ homeopath 11 = homeo= kabiraj /_/ Visit 1 Type of health facility codes: Date (approx)-dd/mm/yy Reason Codes: Visit 2 Visit 3 99 . tips etc) If yes.ASK WHETHER ANY TREATMENT WAS GIVEN AND THE COST OF EACH ONE 1 = no treatment 2 = liniments applied locally 3 = kabiraji med (herbal) 4 = homeopathic med 5 = local healer 6 = allopathic med NO 1 2 3 NAME CODE 12a. specify on what. health facility 3 = govt hospital 4 = other hospital/ICDDR. specify illness and give name of clinic also 1 = UTPS or other NGO clinic 2 = govt.14 If yes.(For cough) If the baby DID NOT have COUGH OR FEVER . go to Q.13 12) If the baby had cough and fever .

Were there any other costs (because baby was BF & mother had to stay at home-specify) /_/ /_/ _/_/_/ /_/ /_/_/_/_/_/ /_/_/_/_/_/ SECTION II For termination of ebf. had only BM reported.def 5 = dropper 17b.17A 17a. What did you use for feeding this food 1 = bottle 2 = spoon 3 = both On 24 hours recall Day 1 food Day 2 food 100 . Did your husband lose any wages because baby was sick c. ask Q.22A) 1 = water __/ 2) sugar water __/ 3) Juice __/ 4)ORS /_/_/_/ /_/ /_/ 4 = hand After term.Medicine given (1) Cost (1) Medicine given (2) Cost (2) Medicine given (3) Cost (3) Total medicine costs Total travel costs Service fees Other expenditure If admitted.30 If yes. is there anything besides breast milk that you have fed your baby ? (prompt for water ) 1 = no 2 = yes /_/ If no. 2 = yes ) b.If yes. If yes. ask Q. other food.(anything on 2 successive days) 16. Did you give this food/other food on the next day as well? 1 = no 2 = yes Enter column 3 If no. no.35. ask Q 17D & 18 onwards 17d. how much x. go to Q. Did you lose any wages because you stayed at home (1 = no. days Total expenditure OTHER COSTS 14a. gruel. What did you feed him/her at that time (or when you started giving something in addition to BM 1 = no 2 = yes Enter column 2 (for milk. how much d. What baby`s age (in days) when----(name food) was first started 17c. If yes. go to Q. Since my last visit.

/_/ After applying termination definition. What was baby`s age when comp food was first started (days) /_/_/_/ 22B.24 onwards 22D.31. If yes. day If no. go to Q 22. ask Q. If no.22A 22A.22D (in box) and Q. is there anything else besides breast milk and these fluids that you have fed your baby? (prompt) 1 = no 2 = yes /_/ If no go to Q.def 23.If yes. go to Q. go to Q. /_/ What did you use for feeding this food? 1 = bottle On 24 hours recall PRBF/ PTBF/ EBF Day 1 food 2 = spoon Day 2 food 3 = both 4 = hand 5 = dropper After term. ask following questions 4 = non-BF 101 .31. Did anyone advise you to start this fluid? a) no one __/ b) mother __/ c)mother-in-law __/ e) nurse __/ f)doctor __/ g) FP worker __/ i) PC __/ j) husband __/ k) other __/ If mother is not partial bf. the baby is 1 = EBF 2 = PRedom BF 19A. ask Q. What food did you feed her/him? (enter in column t) 1) Cow`s milk __/ 2) powder milk __/ 3) gruel __/ 4) fruit __/ 5) others __/ Did you give this (name food as mentioned above) enter column 3 on the next /_/ As well 1 = no 2 = yes 22C. the baby is /_/ 1 = EBF 2 = PRBF 3 = PTBF For partial bf. And why did you think baby needed this/these fluids? /_/_/ (write in mother`s words) 20. Since my last visit.EBF 18.31 d) neigh/frnd/relative __/ h) Dai ___/ SECTION II b) (for termination of predominant bf/or feeding ___ [named fluids]) 21. After applying termination definition.

27 only if bottle use has been specified before in Q. so? /_/ 28. 102 .24A. If other milk is given. /_/ /_/ 25.(or was partially bf and now is on ebf0. SPECIAL GROUP QUESTIONS How many days did you breastfeed altogether? If other food is given. And why did you think baby needed these additional (comp) feeds in addition to /_/_/ breast milk (write in mother`s words-to be coded later reasons for individual foods not required) _____________________________________________________ B. how many /_/_/ In what dilution is PM given? If mother say`s “insufficient BM’’ ask why she thought so (to be coded later) /_/ Ask Q. i. 02 = 2 times.e mother has changed her feeding practice.bf on last visit. /_/ 30. eg.29 if breastfed before but stopped now 29. In what dilution is CM given? /_/_/ (Give times dilution. which one do you give? /_/ 1 = infant formula 2 = half cream milk 3 = full cream milk 4 = condensed milk 5 = cow`s milk 9 = comb (Recorded after tin/packet seen by interview) B. Did anyone advise you to start this fluid? a) no one __/ b) mother __/ c)mother-in-law __/ d) neigh/frnd/relative __/ e) nurse __/ f)doctor __/ g) FP worker __/ h) Dai ___/ i) PC __/ j) husband __/ k) other __/ 26A. what was it ? If mother uses a bottle why does she do /_/_/ __________________________________ If baby was non.15y or z 27. times? If concentrated. /_/ __________________________________ Only ask Q. 10 = 10 times) c. /_/_/ D.

Did she observe you while you were breastfeeding to check how you were doing 1 = no 2 = yes ii) Did she show/help you to hold the baby while breastfeeding ? 1 = no 2= yes /_/ /_/ 6= 103 .go to part iii.33. If yes is code 2-6 ask Q.go to part lll Q. did anyone apart from your family and friends.32 If non-bf. Since we visited you the last time. come and advise you about feeding your baby 1 = no one 2 = dai 3 = fp worker 4 = PC 5 = nurse doctor If above is 1.33 32i).Baby maybe Partial bf predom bf ebf Ask following questions: a) If NON –BF: when did you start breastfeeding (baby`s age or b) if PRBF or PTBF: When did you stop other feeds (‘’) /_/_/ c) How and why did you decide to change your babies feeding practice? /_/ ________________________________________________________ _/ ________________________________________________________ ________________________________________________________ (note suggestions by self/media/ health facility/individuals) / To check for PC and FP 31.Q.

CONTRACEPTIVE PRACTICE PART III 33a. /_/ b. /_/_/_/ Have you started having periods again? 1 = no If yes, what was baby`s age in days when it started 2 = yes

34A. Are you using any family planning method to delay your next child? /_/ 1 = no 2 = yes B. /_/_/ If answer is 1,go to Q.36 35A. If yes how are you doing it (prompt for methods)
1 = combined pill 5 = inj 6 = Norplant 7 = bf frequently 8 = homeo 10 = abstinence 11 = more then 1 method 12 = Withdrawal 9 = kabiraj 13 = ligation 2 = prog only 3 = condom 4 = IUD

Number of days abstinence practice postpartum

B. _/ C. /_/

Method started when baby was how old? (days) contraceptive method advised by? 1 = family planning worker 3 = husband 2 = health facility staff 4 = others

/_/-

104

36. /_/

Are the LAM criteria applicable for this mother? 1 = no

2 = yes

37. LAM not applicable because a. BF gap during day > 4 hours /_/ b. BF gap during night > 6 hours /_/ To check on number of actual visits 38A). Since our last visit, please tell us How many times were visited by the FP worker 0 = not visited 1 = visited once B) (for intervention group only) How many times you were visited by the PC OBSERVATIONS 39. Baby`s weight in kg Baby`s weight in kg 40. 41. 42. 43. /_/ Baby`s length in cm Baby`s length in cm Mother`s wt in kg Mother`s MUAC Feeding status 1 = EBF 2 = PRBF 3 = PTBF 4 =NON-BF

/_/

/_/ /_/_/_/ /_/_/_/ /_/_/_/ /_/_/_/ /_/_/_/ /_/_/_/

OTHER OBSERVATIONS and COMMENTS

105

Section 1: Information on Children
Interviewer`s name : 1. Interviewer code (1-6) 2. ID no. 3. Union no. 4. Block and house no. 5.Date of interview ___/ __/__/__/ __/ __ /__/__/__/__/ _ /__/__/__/__/

INTERVIEWER VISITS 1 DATE INTERVIEWER’S NAME RESULT* NEXT VISIT: DATE
TIME

2

3

FINAL VISIT DAY MONTH YEAR 10 INTV. CODE RESULT* TOTAL NO. OF VISITS

**RESULT CODES: 1 COMPLETED 2 NOT AT HOME 3 POSTPONED 4 REFUSED 5 PARTLY COMPLETED 6 RESPONDENT INCAPACITATED 7 OTHER (SPECIFY)
SUPERVISOR FIELD EDITOR OFFICE EDITOR KEYED BY

NAME

NAME

106

Interviewer`s name : 1. Block and house no. 5. Interviewer code (1-6) 2. 3.Date of interview ___/ __/__/__/ __/ __ /__/__/__/__/ _ /__/__/__/__/ INTERVIEWER VISITS DATE DATE 107 . Union no. 4. ID no.

.5 Others………………………………6 Don’t know/not sure…………….1 No……………….. sugar water.…1 Benefits mother ……….. porridge or dal? 108 .1 No……………………………….A Pulses.1 No……………….3 Yes…………..1 Increased intake of foods.E Vegetables……..2 Don’t know……………………….1 No……………………………………….2 Immediately after birth…………..4 Makes no difference…………….3 Age in days……………………… Not applicable/Not yet………………………..…. I Yes…………….….…………………….7 Do nothing to increase……….….……F Milk……………………………….2 Yes…………….………………….….…….999 Age in days……………………… Not applicable/Not yet……………………….…….3 Yes……………...B Fish….G Fruits………………………………H Others…………………………….…2 Increased intake of fluid……………3 Others________________________4 Specify Rice………………………………..…………………….…………………….……..1 Within 24 hours………………….…………….….….2 Don’t know……………………….D Eggs….……………..………..…. vegetables.……………………..……………. honey water.….2 Benefits baby…………………….….….Section:2 Child Feeding Practices Codes and Categories Yes……………………………………….…….1 No……………….....…………………....………………………….………………….999 Skip Q# Questions and Filters 1 Did you breastfed(name)? 2 3 4 How long after birth of (name)did you begin breastfeeding him/her? Did you feed the first milk (colostrum) to this child? What happens if a mother feeds colostrum to a newborn? 5 What did/do you do to increase breast milk production? 21 6 What were those foodsthat you increased the intake for? (Anything else?) 7 8 9 Are you still breastfeeding the child? Are you still exclusively breastfeeding the child? At any time(name) has eaten or drunk anything other than breastmilk? 10 At what age did you first give plain water. or semi-solid or solid foods besides breast milk? 11 At what age did you first give (name) fruits.………C Meat…...2 Upsets baby’s stomach…………..…..…3 Benefits both mother and baby….….…………….…2 After 24 hours of birth………….

.2 Others……………………………….12 At what age did you first give (name) rice...3 Don’t know/not sure……………….. fish or eggs? 13 At what age did you give (name) any other thing in addition to breast milk? 14 What happens if solid food is introduced to a child before 6 months? 15 What happens if solid food is introduced to a child before 6 months? Age in days……………………… Not applicable/Not yet………………………. meat......2 Others……………………………….999 Age in days……………………… Not applicable/Not yet……………………….4 Bad for child…………………………1 Makes no difference………………..3 Don’t know/not sure………………..999 Bad for child…………………………1 Makes no difference……………….. wheat..4 SECTION 3: COMPLEMENTARY FEEDING PRACTCE 109 ....

1 Halwa /Shuji /Fernee…………………....4 Skip 17 If you give family food then what kind of food do you give mostly ? 18 Familyfood………………………………. Bread etc) ………………………………………6 Others (Identify) ……………………………….Q# Questions and Filters 16 What other foods do you give your complementary food is given to your child? Codes and Categories Khichuri……………………………… .…………………………………….. Biscute..3 Pitha……………………………………4 Family food…………………………….6 Others (Identify)…………………………...5 Food from shops (Cake .2 Fruits………………………………… .7 N/A………………………………………88 Yes……………………………………… Do you prepare the 1 complementary food No ……………………………………… with oil for your child? 2 (If N/A=88 don't feed Complementary /__/__/ feeding ) How many days do you cook khichuri for last seven days? / __/__/ Days…………………………………… (If N/A=88 don't feed Complementary feeding) Days…………………………………… (If N/A=88 don't feed Complementary feeding ) Days…………………………………… (If N/A=88 don't feed Complementary feeding ) 19 20 21 How frequent the child is feed khichuri for the days cooked? How many eggs are given to the child for last seven days ? /__/__/ 22 How many fruits did you give to the baby for last seven days? Days…………………………………… (If N/A=88 don't feed Complementary feeding ) 110 . Bread etc)………………………………….5 Food from shops (Cake .7 N/A……………………………………88 Khichuri…………………………………… 1 Halwa /Shuji /Fernee……………………… 2 Fruits. 3 Pitha………………………………………. Biscute..

a. a. . a. . b. . a. . Questions and Filters Lentgh in cm (1st time) Lentgh in cm (2nd time) Lentgh in cm (3rd time) Weight in Kg (1st time) Weight in Kg (1st time) MUAC(mm) Codes and Categories Skip .SECTION 4: FOOD FREQUENCY QUSETIONNAIRE (24 hour Recall Method& 7 days) o 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 Name of the food Rice (cup) Bread/ chapati (piece) Pulse (cup) Meat / Fish (piece) Egg (piece) Milk (Cup) Khichuri (Normal) Khichuri (Formulated cup) Leafy vegetable (cup) Fruits (piece) Halua/suji/Firni (cup) Chira/ Muri (cup) Biscuit Sugar/Gur (tea spoon) Oil (tea spoon) Others (identify) Quantity Frequency 7 days Anthropometry measurement Q# 17. 18. 18. 17. 19. b. 111 . . 17.

Ending Time: Hour Minutes 112 .

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