A RCT Comparing Balanced Energy Deficit Diets With or Without Meal Replacements for Weight Loss and Maintenance Among Children Dieting Alone or With a Parent

Abstract

We compared the safety and efficacy of supplemental Medifast portion-controlled meal replacements (MRs) with a USDA Food Guide Pyramid-based diet. Both weight loss diets were 20% energy-restricted (~500 kcal deficit). 80, 8–15yo children, BMI>95th%ile, were screened and 40 randomized to either a MR diet (3 MRs/d during active weight loss and 2 MRs/d during maintenance) or to the food-based diet. Subjects were further randomized to dieting alone or with a parent. Results: By ITT analysis, dieting with a parent, or food vs MR, made no difference in weight outcome. However, following initial weight loss (6mos) and 1yr maintenance (18mos), significant (p<0.05) decreases were seen in the MR group in BMI%ile (0 mos=98.8 +/− 1.0, 6 mos=96.6 +/− 3.2, 18 mos=96.4 +/− 3.4); body fat (5.9%@6 mos, 5.3%@ 18 mos), total cholesterol (6.7%, 5.6%), LDL (19.8%, 7.9%) and triglycerides (23.6%, 22.3%). No significant between-group differences, differences in growth rates, or adverse events were observed. Conclusions: Among overweight 8–15yo children, dieting with or without a parent, meal replacements were as safe and effective as a food-based diet for weight loss and maintenance. (Supported by Medifast Inc., MD).