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THE OPTIWIN STUDY
OPTIWIN is a year-long, head-to-head study, designed to evaluate the effectiveness of a medically monitored, behavioral, meal replacement weight loss program (the OPTIFAST Program) on weight loss and maintenance, in comparison with a standard-of-care, reduced-energy, food-based diet (modiefied version of Diabetes Prevention Program, DPP) and lifestyle intervention among adults with a BMI higher than 30.
Study Design

Duration
52 weeks: 26-week weight loss phase, followed by a 26-week weight maintenance phase.

How?
Open-label, randomized, controlled trial

Where?
multicenter (9 sites across the U.S.)

Participants
multicenter (9 sites across the U.S.)
Method


(n=135 mITT*)
ACTIVE PHASE:
- Total meal replacement up to 16 weeks
- 800 kcal/day, based on BMI
- 40% carbohydrate, 40% protein, 20% fat
- Gradual introduction of food
MAINTENANCE:
Conventional food, encouraged 1-2 meal replacements per day.

FOOD-BASED PROGRAM
(n=135 mITT*)
ACTIVE PHASE:
- Reduced energy (-500 to -750 kcal/day, 25% to 30% fat) diet based on modified Diabetes Prevention Program for 26 weeks.
MAINTENANCE:
Increased energy intake to achieve weight maintenance.
IN BOTH GROUPS
150-180 minutes per week of moderate to vigorous intensity exercise
Group (weekly) and individual (per schedule) behavioral counseling sessions.
Results
Mean weight loss
Patients lost 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
