Assessment of Change in Body Size
We calculated percentage change in body weight from the difference in weight over the first 2 years after randomization as (weight at annual visit 2 − baseline weight) / baseline weight, expressed as a percentage. Change in WC was measured in a similar manner. The values for change in body-size indices (weight and WC) were divided into 5 categories: change within 5% (stable), decrease by 5% to 10%, decrease by more than 10%, increase by 5% to 10%, and increase by more than 10%.