52 weeks: 26-week weight loss phase, followed by a 26-week weight maintenance phase.
Open-label, randomized, controlled trial
Multicenter (9 sites across the U.S.)
330 eligible for study; 273 in the mITT* study population
In both groups
150-180 minutes per week of moderate to vigorous intensity exercise
Group (weekly) and individual (per schedule) behavioral counseling sessions
Total meal replacement up to 16 weeks
800 kcal/day, based on BMI
40% carbohydrate, 40% protein, 20% fat
Gradual introduction of food up to 26 weeks
Conventional food, encouraged 1-2 meal replacements per day.
Reduced energy (-500 to -750 kcal/day, 25% to 30% fat) diet based on *modified Diabetes Prevention Program for 26 weeks.
Increased energy intake to achieve weight maintenance.
Mean weight loss (%)
Patients lost approximately 2x as much weight using the OPTIFAST® Program
Mean change in total fat mass (kg)
OPTIFAST® Program patients achieved greatest reductions in total fat mass
Mean change in waist circumference (cm)
Patients experienced greater reductions in waist circumference using the OPTIFAST® Program
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