CONSORT 2010 checklist of information to include when reporting a randomised trial *

Item Reported
Section/Topic No Checklist item on page No
Title and abstract
1a Identification as a randomised trial in the title Tidak ada
1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) Halaman 1
Introduction
Background and 2a Scientific background and explanation of rationale Halaman 2
objectives 2b Specific objectives or hypotheses Halaman 2

Methods
Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio Halaman 2
3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Halaman 2
Participants 4a Eligibility criteria for participants Halaman 2
4b Settings and locations where the data were collected Halaman 2
Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were Halaman 3-4
actually administered
Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they Halaman 2-3
were assessed
6b Any changes to trial outcomes after the trial commenced, with reasons Halaman 2-3
Sample size 7a How sample size was determined Halaman 2
7b When applicable, explanation of any interim analyses and stopping guidelines Tidak ada
Randomisation:
 Sequence 8a Method used to generate the random allocation sequence Halaman 3
generation 8b Type of randomisation; details of any restriction (such as blocking and block size) Tidak ada
 Allocation 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), Halaman 2-3
concealment describing any steps taken to conceal the sequence until interventions were assigned
mechanism
 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to Halaman 2
interventions

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Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those Tidak ada
assessing outcomes) and how
11b If relevant, description of the similarity of interventions Tidak ada
Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes Halaman 3
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses Halaman 3
Results
Participant flow (a 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and Halaman 3
diagram is strongly were analysed for the primary outcome
recommended) 13b For each group, losses and exclusions after randomisation, together with reasons Tidak ada
Recruitment 14a Dates defining the periods of recruitment and follow-up Tidak ada
14b Why the trial ended or was stopped Tidak ada
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group Halaman 4-5
Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was Tidak ada
by original assigned groups
Outcomes and 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its Halaman 3
estimation precision (such as 95% confidence interval)
17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Halaman 3
Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing Halaman 3
pre-specified from exploratory
Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) Tidak ada
Discussion
Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Tidak Ada
Generalisability 21 Generalisability (external validity, applicability) of the trial findings Tidak Ada
Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Halaman 6
Other information
Registration 23 Registration number and name of trial registry Halaman 5
Protocol 24 Where the full trial protocol can be accessed, if available Halaman 9
Funding 25 Sources of funding and other support (such as supply of drugs), role of funders Tidak ada

*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also
recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials.
Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.

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KETERANGAN :
1. Title and abstract
a. Identification as a randomised trial in the title
Randomize trial  merupakan design penelitian dengan menggunakan subjek secara acak baik dengan menggunakan kelompok kontrol dan
kelompok terpapar yang selanjutnya akan dibandingkan hasilnya.
b. Structured summary of trial design, methods, results, and conclusions
Sudah dijelaskan secara singkat dan terstruktur pada abstrak, tetapi trial design yang digunakan tidak disebutkan.
2. Introduction (Background and objectives)
a. Scientific background and explanation of rationale
Alasan dilakukan penelitian ini dikarenakan adanya peningkatan kejadian dari permasalahan obesitas di dunia yang dapat menigkatkan
kemungkinan terjadinya penyakit kardiovaskuler dan peningkatan faktor resiko terjadinya sindrom metabolik. Ada beberapa metode yang dapat
dilakukan seperti diet portion control, energy density, dan glycemic index.
b. Specific objectives or hypotheses
Untuk mengukur hubungan kadar IMT dengan masing-masing jenis diet yang akan dilakukan.
3. Method
3)Trial design
a. Description of trial design (such as parallel, factorial) including allocation ratio
Kalo paralel akan dibagi menjadi dua kelompok yang sleanjutnya akan dibandingkan hasilnya. Kalau faktorial berdasarkan studi populasi tidak
dilihat dari segi hasil. Pada penelitian ini lebih ke paralel. Penelitian ini dilakukan dengan pendekatan prospektif yang selanjutnya dilihat dari ketiga
kelompok subjek penelitian.
b. Important changes to methods after trial commencement (such as eligibility criteria), with reasons
4)Eligibility criteria for participants
a. Eligibility criteria for participants
Meliputi kriteria inklusi dan ekslusi dari subjek. Jumlah awalnya ada 466 orang yang selanjutnya dilakukan screening dan didapatkan hasil berupa
157 subjek penelitian
b. Settings and locations where the data were collected
Berada di Floridina hospital institutional
5)Interventions
a. The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
Intervensi yang dilakukan dijelaskan berdasarkan jenis diet yang dilakukan oleh subjek yaitu diet PC, LED group dan LGI. Pada
6)Outcomes
a. Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
7) Sample size
CONSORT 2010 checklist Page 3
 a. How sample size was determined
total sampling yang digunakan pada penelitian ini.

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Randomisation:
 Sequence 8a Method used to generate the random allocation sequence
generation Pembagian kelompok dilakukan secara random pada tiap kelompok.
8b Type of randomisation; details of any restriction (such as blocking and block size)
 Allocation 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers),
concealment describing any steps taken to conceal the sequence until interventions were assigned
mechanism
 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to
interventions
Pendaftaran dilakukan oleh partisipan dan akan didata oleh peneliti. Selanjutnya yang menentukan interversi
kepada subjek didasarkan pada expert diet nutrisi
Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those
assessing outcomes) and how
Tidak ada
11b If relevant, description of the similarity of interventions
Tidak ada
Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes
Menggunakan T test berpasangan, Independen T test dan ANOVA
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses
Results
Participant flow (a 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and
diagram is strongly were analysed for the primary outcome
recommended) Ada 226 dilakukan screening didapatkan 157 subjek dan selanjutnya dibagi mengjadi 3 kelompok yaitu 57
LED, 59 LGI, dan 41 PC.
13b For each group, losses and exclusions after randomisation, together with reasons
Tidak dijelaskan kenapa di ekslusi, mungkin karena calon subjek tidak masuk ke dalam kriteria inklusi
Recruitment 14a Dates defining the periods of recruitment and follow-up
Tidak dijelaskan
14b Why the trial ended or was stopped
Tidak dijelaskan
Baseline data 15 A table showing baseline demographic and clinical characteristics for each group
Terdapat perubahan dari massa tubuh, BMI, Body Fat, Fat mass, dan fat free mass dari masing-masing
kelompok pada tiap kelompok dari LED, LGI dan PC seperti .

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Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was
by original assigned groups
Tidak terdapat denominator
Outcomes and 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its
estimation precision (such as 95% confidence interval)
confidence interval pada penelitian ini 95% karena p < 0,05
17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Tidak ditemukan perbedaan yang signifikan dari tiap metode diet yang dilakukan pada penelitian. Oleh karena
itu dapat diketahui bahwasannya ketiga kelompok efektif untuk menurunkan berat badan
Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing
pre-specified from exploratory
Tidak dijelaskan
Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)
Tidak dijelaskan
Discussion
Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
Penelitian hanya dilakukan selama 12 minggu, distribusi genjer tidak merata, dan menyarankan kedepannya
dilakukan penelitian yang sama tetapi dengan menggunakan subjek laki-laki, tingkat drop out nya tidak diteliti.
Generalisability 21 Generalisability (external validity, applicability) of the trial findings
Tidak disebutkan pada jurnal ini.
Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
Hasil yang diperoleh pada penelitian ini sesuai dengan hasil penelitian terdahulu yang telah dilakukan.
Other information
Registration 23 Registration number and name of trial registry
Dijelaskan dengan cara mendaftar dengan cara menelfon yang selanjutnya di screening sehingga didapatkan
sumber yang ada.
Protocol 24 Where the full trial protocol can be accessed, if available
Tidak dijelaskan, hanya disebutkan untuk mengakses jurnal ini.
Funding 25 Sources of funding and other support (such as supply of drugs), role of funders
Tidak ada

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