At a glance
ClinicalIndex Comparison Record- ✓BMI 27.0 to 42.0 kg/m² at start of intervention
- ✓Judged in good health based on medical history and screening laboratory assessments
- ✓Willing to modify physical activity per study recommendations
- ✓Interested in weight loss and ready to do so
- ✕Weight loss or gain >5% in 6 months before screening (except post-partum weight loss)
- ✕Used medications, products, supplements, or diets to alter body weight within 6 months of screening
- ✕History of weight-reducing surgery or liposuction
- ✕History or presence of clinically important cardiac, renal, hepatic, endocrine (diabetes requiring medication), pulmonary, biliary, pancreatic, or neurologic disorders
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled, 3-Arm Clinical Trial to Assess Weight Loss Using the Take Shape For Life Program or the Medifast Direct Program Versus a Self-Directed Diet
In Brief
A clinical study evaluating Take Shape For Life Program, Medifast Direct Program, and 1 other intervention for Overweight and Obesity. Completed, enrolled 198 participants across 1 site.
Detailed Summary
The study evaluates the effects of two commercially available weight loss programs, the TSFL and the MEDD programs, each compared to a self-directed control diet, on changes in body weight over a 16-week weight loss phase, in apparently healthy overweight and obese men and women.
Study Details
Timeline
Interventions
The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 \& 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.
The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 \& 2 \& 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.