Lead-in period
Eligible participants were enrolled in a 12-week intensive lifestyle intervention lead-in period. The lead-in lifestyle intervention included frequent in-person lifestyle counseling sessions (that is, eight sessions over 12 weeks), delivered by a dietitian or similarly qualified healthcare professional. Women were instructed to consume approximately 1,200 kcal per day and men 1,500 kcal per day. The dietary intervention could include up to two meal replacements (liquid meal replacements or prepackaged, portion-controlled meals) per day. Participants were encouraged to engage in at least 150 min of moderate-intensity physical activity per week (for example, brisk walking). They were counseled on behavior modification strategies to help implement and adhere to the diet and exercise recommendations, and were encouraged to complete 3-day diet and exercise logs before each counseling visit.