Oral Nutrition Supplements and Weight Loss 1

Nutrition Intervention & Patient Outcomes Study

Hannah Bodenhamer

School of Kinesiology and Nutrition, University of Southern Mississippi

NFS 780: Advanced Practice in Nutrition and Food Systems

Professor Roxanne Kingston, MS, RD, LD

December 1, 2021
 Oral Nutrition Supplements and Weight Loss 2

Abstract

The incidence of malnutrition and significant weight loss is highly underestimated in

hospitalized adults yet significantly impacts patient outcomes. One major cause of malnutrition

and significant weight loss is inadequate energy and protein intake. Using oral nutrition

supplements (ONS) to improve daily nutrition intake may be a solution to protein-calorie

malnutrition and related weight loss. Adult residents at Palm Terrace Healthcare and

Rehabilitation center were screened for malnutrition and significant weight loss using a Mini

Nutrition Assessment (MNA), then offered daily ONS. This research observation study evaluates

the incidence of significant weight loss between residents who received ONS or refused ONS

over the course of 12 weeks. The primary outcome was the change in body weight and

incidence of significant weight loss (1-2% in one week, >5% in one month, >7.5% in three

months, >10% in six months). Twenty-five patients (95% CI, p=0.05) were observed throughout

the study for the use of ONS and changes in weight. The supplementation outcomes were

analyzed using descriptive statistics (mean/SD, frequency/percentage) and inferential statistics

(t-test). The evaluation of patient outcomes found a significant decrease in significant weight

loss amongst patients receiving ONS (n=15) compared to those who refused ONS (n=10). ONS

are an effective intervention in preventing malnutrition and significant weight loss; benefits are

apparent within the first four weeks of intervention and maintained throughout the study.
 Oral Nutrition Supplements and Weight Loss 3

Literature Review

Malnutrition is a medical condition that can cause severe complications and is often left

unrecognized and untreated. Malnutrition is defined as an imbalance of nutrition and is further

classified as undernutrition and overnutrition. In most healthcare settings, malnutrition refers to

undernutrition or the lack of adequate nutrition. The relation between malnutrition (herein

referring to undernutrition) and adverse health outcomes is well-established; a journal published

in Better Patient Advocacy Center (n.d.) lists these outcomes as poor immune function, reduced

wound healing, and declining muscle strength. The adverse outcomes for malnutrition include

increased healthcare costs, significant weight loss, extended hospital stays, increased risk for

complications, decreased mental and general function, accelerated body mass loss, and

increased mortality risk (Abbott, n.d.). Given the sizable impact of malnutrition on healthcare,

early and adequate nutrition intervention is warranted to improve patient outcomes. The Medical

Nutrition International Industry (MNI) listed oral nutrition supplements (ONS) as a successful

nutrition intervention for disease-related malnutrition (2012). At a low relative cost and reported

high health benefits, ONS may be a promising solution to malnutrition.

ONS contain additional calories and nutrients that contribute to total daily

nutrition. These supplements come as ready-made shakes or powders to be mixed with water or

milk (BPAC, n.d.). These supplements are an imperative nutrition intervention for patients who

have poor oral intake and risk for significant weight loss and malnutrition (Abbott, n.d.).

Evidence proves ONS to be a successful intervention for malnutrition as this type of

supplementation increases energy intake and reduces weight loss. A systematic review from

Cochrane Library (2011) verified that nutrition supplementation with diet education resulted in

beneficial weight changes, improved body composition, and increased grip strength. Decreased

energy intake, weight loss, body fat loss, loss of lean body mass, fluid accumulation, and

reduced grip strength are indications of malnutrition; resolving these conditions result in treating
 Oral Nutrition Supplements and Weight Loss 4

malnutrition. As evidenced by the Cochrane review (2011), ONS is an effective intervention for

malnutrition.

Moreover, ONS use may mitigate the risk for malnutrition in patients who do not meet

malnutrition diagnostic criteria. Many facilities use Mini Nutrition Assessments (MNA),

Subjective Global Assessments (SGA), Patient-Generated Subjective Global Assessments

(PG-SGA), and Malnutrition Universal Screening Tool (MUST) to screen for malnutrition. A

predominant indicator of malnutrition is weight loss, which is a focus in many of these screening

tools. These screening tools will not flag every patient as malnourished; some may score as at

risk for malnutrition. Nutrition intervention in patients at risk for malnutrition is critical to reduce

the incidence of adverse health outcomes, liability for healthcare facilities, and hospital

readmission rates. Nutrition status and weight loss are assumed to worsen among most

admitted older adults during hospital stays (MDPI, 2019). For this reason, early nutrition

intervention to improve nutrition status is critical in reducing malnutrition incidence in

hospitalized adults. By improving nutrition status in patients at risk for malnutrition, ONS use

may significantly impact patient outcomes (Abbott, n.d.).

Preferred by many clinicians, a ‘food first’ approach to health is frequently used as an

intervention for malnutrition and weight loss (BPAC, n.d.). A ‘food first’ approach to nutrition

intervention requires patients to eat small, frequent meals high in energy, protein, and nutrients.

Many patients may not tolerate a ‘food first’ approach due to a variety of health conditions

including, but not limited to, poor appetite, dysphagia, certain medications, cancer, surgery,

sepsis, and chronic kidney disease (CKD). Further nutrition intervention should be implemented

if patients have persistent poor intakes of food, complaints of poor appetite, trends of weight

loss, and muscle or fat wasting. ONS may aid patients in maintaining body mass and adequate

nutrition status. If these interventions fail and signs of malnutrition persist, more aggressive

forms of intervention such as enteral and parenteral nutrition may be necessary.

 Oral Nutrition Supplements and Weight Loss 5

The frequency and prevalence of malnutrition and weight loss in hospitalized adults are

severely underestimated. The impact of which can have an extensive impact on healthcare

costs and patient outcomes. Successful nutrition interventions for malnutrition include a ‘food

first’ approach, ONS, and enteral and parenteral nutrition. ONS should be implemented only

after attempting a ‘food first’ approach. These supplements should be used between meals to

add to daily intake rather than replace intake. ONS can potentially impact patient outcomes by

reducing malnutrition and weight loss. Therefore, the current research aims to evaluate the

impact of ONS on weight loss in hospitalized adults.

 Oral Nutrition Supplements and Weight Loss 6

Study Questions and Objectives

Question: Do oral nutrition supplements reduce significant weight loss (1-2% in one week, >5%

in one month, >7.5% in three months, >10% in six months) occurrence in patients with less than

50% oral intake?

Null Hypothesis: Oral nutrition supplements have no effect on significant weight loss (1-2% in

one week, >5% in one month, >7.5% in three months, >10% in six months) in patients with poor

oral intakes.

Objective 1: This study will assess the initial weights of patients receiving oral nutrition

supplements.

Objective 2: The researchers will collect information about oral intake on patients experiencing

weight loss.

Objective 3: This study will assess patient weight loss once a week for twelve consecutive

weeks.
 Oral Nutrition Supplements and Weight Loss 7

Methodology and Procedures

Study Design

The design for this research study is recorded observation. Recorded observation

studies evaluate the applicability of evidence and interventions used (Dreyer et al., 2010). A

recorded observation design will allow researchers to observe the outcomes of oral nutrition

supplements on patient weight loss. Weight loss trends can be found in patient charts and are

recorded weekly. Certified Nursing Assistants (CNAs) are trained to properly document the

consumption of meals and oral nutrition supplements in patient charts. Observers may view all

necessary data on the virtual patient charting system and do rounds in the afternoon, when

supplements are administered, to assess oral nutrition supplement intake and patient likeability.

The patient selection criteria for this recorded observation study will be discussed in the next

section.

Participant Selection

Residents have full health autonomy; therefore, oral nutrition supplements will be offered

to patients who meet the inclusion criteria but are not required. Outcomes will be measured for

those who choose to receive oral nutrition supplements versus those who refuse. Twenty-five

patients with trending weight loss will be included in the study (95% confidence interval, 0.05

margin of error). The registered dietitian (RD) completes a Mini Nutrition Assessment (MNA) for

each resident entering the facility. This MNA will flag patients at risk for malnutrition and patients

suspected to be malnourished (see figure 1). The RD will list patients who are flagged as

malnourished (MNA scores of 0-7)and offer each resident an oral nutrition supplement to

increase daily nutrition intake. This information will guide the observers in their observation.
 Oral Nutrition Supplements and Weight Loss 8

Further selection will include patients' trends of significant weight loss (1-2% in one

week, >5% in one month, >7.5% in three months, >10% in six months), an RD or doctor order

for oral nutrition supplement, trends of poor oral intake (>50% average), and orders for weekly

weights (Nelms, 2020). Exclusion criteria will include residents receiving enteral nutrition

support, the presence of significant edema or diuretic drug use that may artificially impact

weight, and antibiotic or appetite stimulant use that may artificially impact appetite. Patient data

is kept on an online charting system that is password protected. Observers will assign a code or

number to each included resident and manually record data on separate data evaluation

software. Resident names and identifying information will not be recorded or shared. These

measures are in place to comply with HIPAA laws and protect patient personal information.

Analysis

This study will be observing changes in weight for 12 consecutive weeks with relation to

oral nutrition supplement use. Table 1 in the appendix provides an example of the instrument

used to collect the data. This study will evaluate both descriptive statistics and inferential

statistics. Descriptive statistics describe the data features in a study, providing summaries of the

recorded measures (Trochim, n.d.). This study will record usual body weight (UBW), changes in

weight, the number of oral nutrition supplements ordered, and oral intake. UBW, weight

changes, number of oral nutrition supplements ordered will be compared using mean or

standard deviation statistical tests because these data sets are nominal. Oral intake will be

compared using frequency or percentage statistical tests because this data set is recorded as

ranges: 0-25%, 25-50%, 50-75%, and 75-100% oral intake. Inferential statistics are used to

draw conclusions or inferences about the recorded data (Trochim, n.d.). This study will compare

UBW, weight changes, number of oral nutrition supplements ordered, and oral intake using

t-tests to measure the mean between groups of continuous data sets. Using 0.05 degrees of
 Oral Nutrition Supplements and Weight Loss 9

freedom, researchers will determine a t-value for each data set and perform an independent or

unpaired t-test to determine if the null hypothesis should be rejected.

 Oral Nutrition Supplements and Weight Loss 10

Dissemination Plan

After data analysis and determining whether to reject or accept the null hypothesis, the

researchers will prepare a report to share with the facility’s RD, directors, administration, and

corporate representatives. This report should describe the collected data, statistical analysis of

the data, and recommendations supported by the findings. The aim of this presentation should

be to support or reject the null hypothesis: oral nutrition supplements do not affect significant

weight loss (1-2% in one week, >5% in one month, >7.5% in three months, >10% in six months)

in patients with poor oral intakes. This presentation should include a table displaying the

findings (table 1), a distribution of the data set (figure 2), and a graph comparing the findings

(figure 3). The researchers should be prepared to describe their observations, explain the

statistical significance of the data, and draw connections between findings. The findings will aid

the administration’s decision in whether or not to increase the budget for oral nutrition

supplement use. If the findings show a significant link between oral nutrition supplement use

and weight loss prevention, the administration should be proactive in encouraging this

intervention. The findings of this study are significant because the outcomes will determine

whether or not a new nutrition intervention policy will be created.

Oral Nutrition Supplements and Weight Loss 11

References

Baldwin, C., & Weekes, C. E. (2011). Dietary advice with or without oral nutritional

supplements for disease-related malnutrition in adults. Cochrane Database of

Systematic Reviews. https://doi.org/10.1002/14651858.cd002008.pub4

Dreyer, N. A., Tunis, S. R., Berger, M., Ollendorf, D., Mattox, P., & Gliklich, R. (2010). Why

observational studies should be among the tools used in comparative effectiveness

research. Health Affairs, 29(10), 1818–1825.

https://doi.org/10.1377/hlthaff.2010.0666

Nahikian-Nelms, M. (2020). Nutrition therapy and pathophysiology. Cengage.

Nutrition intervention with oral nutritional supplements. Nutrition Intervention with Oral

Nutritional Supplements. (n.d.). Retrieved November 28, 2021, from

https://abbottnutrition.com/clinical-studies/nutrition-intervention-with-ons.

Oral nutritional supplements to tackle malnutrition. Medical Nutrition International Industry

(MNI). (2009). Retrieved November 28, 2021, from

https://medicalnutritionindustry.com/files/user_upload/documents/ONS_2012/Dossi

er2012FINAL2012-09-04.pdf.

Roberts, H. C., Lim, S. E., Cox, N. J., & Ibrahim, K. (2019). The challenge of managing

undernutrition in older people with frailty. Nutrients, 11(4), 808.

https://doi.org/10.3390/nu11040808
Oral Nutrition Supplements and Weight Loss 12

Strategies to improve nutrition in elderly people. Strategies to improve nutrition in elderly

people - Prescription foods. (n.d.). Retrieved November 28, 2021, from

https://bpac.org.nz/bpj/2011/may/elderly.aspx.

Trochim, P. W. M. K. (n.d.). Analysis. Research Methods Knowledge Base. Retrieved

December 4, 2021, from https://conjointly.com/kb/research-data-analysis/.

 Oral Nutrition Supplements and Weight Loss 13

Appendix

Figure 1: Flow chart of ONS recommendations and malnutrition screening

 Oral Nutrition Supplements and Weight Loss 14

Figure 2. T-test distribution for Changes in Body Weight comparing ONS and Refused ONS
 Oral Nutrition Supplements and Weight Loss 15

Figure 3. Incidence of Weight Loss with ONS and without ONS

 Oral Nutrition Supplements and Weight Loss 16

Patient Code ONS? UBW Week 1 Week2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12
Y/N

Table 1. Data collection tool for the research observation study