BACKGROUND: Health professionals are in need of more information about the weight-loss outcomes of using commercial weight-loss programs. OBJECTIVE: A commercial behavioral intervention program using meal replacements, fruits, and vegetables (MR-FV) was compared with usual-care weight-loss counseling. DESIGN: Obese volunteers were randomly allocated to usual-care weight-loss counseling or participation in an MR-FV standardized behavioral education program. The MR-FV group attended weekly weight-loss classes for 16 weeks and weekly maintenance classes for 8 weeks. PARTICIPANTS/SETTING: Obese women or men aged 20 to 65 years were recruited from the community through a commercial program provided at a university medical center. INTERVENTION: The control group (C group) received weight-management counseling from an experienced dietitian, while the intervention group (MR-FV group) participated in scheduled behavioral weight-loss classes. The MR-FV group participants were encouraged to consume 3 shakes, 2 entrées, and 5 servings of fruits or vegetables daily, and achieve physical activity goals (expend ≥ 8.4 mJ/week); they kept records and placed midweek phone calls. The C group was counseled at baseline, 8 weeks, and 16 weeks. OUTCOME MEASURES: Both groups were seen at baseline, and 8, 16, and 24 weeks for assessment of weight, risk factors, and side effects. STATISTICAL ANALYSIS: The primary data analysis was intention to treat. RESULTS: Thirteen of 16 subjects (81.3%) in the C group and 18 of 22 subjects (81.8%) in the MR-FV group completed the 24-week study. Mean weight losses for the C group were: 1.3% (standard error [SE], 0.9) at 8 weeks; 0.7% (SE, 1.1) at 16 weeks; and 0.7% (SE, 1.1) or 0.7 kg at 24 weeks. Mean weight losses for the MR-FV group were: 8.5% (SE, 0.6) at 8 weeks, 12.5% (SE, 0.9) at 16 weeks, and 13.9% (SE, 1.1) or 13.7 kg at 24 weeks. CONCLUSIONS: A behavioral intervention with a low-energy diet including 5 meal replacements and 5 servings of fruits or vegetables enabled obese individuals to lose 13 kg more than control subjects over a 24-week period.