Randomised Pilot Trial

The pilot trial is not powered to determine efficacy for weight loss or body composition. The trial uses an intent-to-treat analysis strategy with multiple imputation for missing data. Allocation concealment is managed through a REDCap-based randomisation list accessible only to the research coordinator after baseline measurement. The 70% adherence threshold was based on the research team's systematic review and expert guidelines. The study is a 16-week, three-arm pilot RCT conducted across three Canadian centres. Outcomes are measured at baseline, at 16 weeks (end of intervention), and at 32 weeks after randomisation. The primary endpoints are feasibility outcomes including enrolment rate, intervention adherence, and retention. The enrolment threshold of 2 participants per month is designed to support a future trial of about 200 participants within a 5-year timeframe.