Date

2026-08-07

Protocol

Protocol changed

Item Changed

Primary outcome(s)

Previous Version

Primary outcome: BMI Absolute reduction of BMI from baseline Absolute change: BMI Week 26 – BMI Week 0 Relative change in BMI Middle of intervention: (BMI Week 13 – BMIWeek0) ÷ BMI Week0 ×?100%  Post-Intervention: (BMI Week 26 – BMIWeek0) ÷ BMI Week0 ×?100%

Next Version

Primary outcome: BMI z- score Measurement variable: BMI is calculated as body weight (kg) divided by height squared (m2) and converted to a BMI z-score using the WHO AnthroPlus software. Analysis metric: Reduction from baseline (Change in BMI z-score = BMI z-score at week 26 ? BMI z-score at week 0)