Date

2026-09-28

Protocol

Protocol changed

Item Changed

Secondary Outcome

Previous Version

Anthropometric parameters Measurement variable -Mid-upper arm circumference, Waist circumference, Body fat Analysis metric - reduction from baseline -Method of aggregation- mean(SD) Biochemical parameters Measurement variable -Fasting blood sugar (FBS), HbA1c, Insulin, Leptin levels, Lipid profile, Liver function test

Next Version

Outcome -Anthropometric parameters • Measurement variable -Mid-upper arm circumference, Waist circumference, Body fat • Analysis metric- reduction from baseline • Method of aggregation- mean(SD) • Time point- Baseline (Week 0), Middle of the intervention (Week 13), Post-Intervention (Week 26) Outcome – Selected biochemical parameters • Measurement variable -Fasting blood sugar (FBS), HbA1c, Insulin, Leptin levels, Lipid profile, Liver function test • Analysis metric- Improvement from baseline • Method of aggregation- Mean (SD)/ Median (IQR) • Time point- Baseline (Week 0), Post-Intervention (Week 26) Outcome - rs17782313 polymorphism in the MC4R gene • Measurement variable: MC4R rs17782313 genotypes (TT, TC, CC) and allele frequencies (T and C) • Analysis metric: Frequency and percentage of participants with each genotype and allele • Method of aggregation: Counts and percentages • Time point: Baseline (week 0) This protocol amendment (addition of rs17782313 polymorphism in the MC4R gene as one of the secondary outcomes) has been approved by the Research Ethics Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura, at its meeting held on 24 September 2026. Annexed approval letter.