Statistical Analysis
Based on a previous studyAll the participants were included in the intention-to-treat (ITT) analysis. Modified ITT analysis included all randomized participants who completed at least 12 weeks of the intervention. Per-protocol analysis included participants who adhered to the treatment protocol. Safety set included the data collected for participants who received at least 1 intervention after randomization and for whom safety indicators were documented. Primary analyses were conducted using multiple imputation methods for missing observations at baseline, post intervention, and at follow-up, assuming missing data are missing at random. Prespecified sensitivity analyses were conducted for all participants using complete-case data at each time point. We also compared treatment effects in each group after adjusting for participant self-reported dietary calories and physical activity using a generalized linear model.We report continuous variables as mean (SD) or median (IQR). We used 1-way analysis of variance or the Kruskal-Wallis test for between-group comparisons as appropriate. Categorical variables were described using numbers and percentages and analyzed using the χ