Pilot Meal Replacement-Based Diet Effectiveness Study

Obesity is a risk factor for a number of serious medical comorbidities and is second only to smoking as the leading cause of preventable death in the US. Further, estimates of the costs associated with overweight and obesity have topped $200 billion annually. The numbers are particularly alarming for adolescents, in whom the rate of obesity has risen at 2-3 times as quickly as in adults. Despite the urgent need, very few clinical centers offer obesity treatment due to the resource-intensive nature of most interventions and the fact that behavioral obesity interventions have rarely been reimbursed by 3rd party payers. Following the American Medical Association's recent decision to recognize obesity as a disease and establish ICD-10-CM Diagnosis Codes (e.g., E66.0), however, there is increasing pressure for 3rd party payers to reimburse for effective obesity interventions. Thus, it is critical to identify effective treatment options that can be implemented in medical centers. Prior research has shown meal replacement-based diets to be more effective than typical "lifestyle-change" diet programs, both in terms of weight loss and, more importantly, weight loss maintenance. Evidence also suggests that solid meal replacements (e.g., bars) show greater effectiveness than liquid meal replacements (e.g., shakes). Finally, greater effectiveness is seen with meal replacements that are higher vs. lower in protein. Importantly, these interventions show high rates of effectiveness even in the absence of nutritional counseling, suggesting that a solid meal-replacement based diet program that is relatively high in protein could be highly effective and easily implemented in clinical settings. In this pilot study, 90 adolescents will be randomized to either a meal replacement-based diet (experimental) group or an educational video (comparison) group.

All recruitment and study procedures will take place at the Mount Sinai Adolescent Health Center (MSAHC). The MSAHC is the largest adolescent-specific, integrated, primary care facility in the U.S., and is a unique model that integrates medical, sexual, reproductive, mental health and health education services. MSAHC provides inner-city youth ages 10-24 who are predominately youth of color high quality, comprehensive, easily accessed, free services. Flyers will be posted in the clinic of the Mount Sinai Adolescent Health Center.

At the baseline assessment following recruitment, participants will provide informed consent and complete a structured interview conducted by research staff to more formally assess eating patterns and eating disorders symptomatology. Assessors will conduct interviews at the MSAHC on an individual basis. If a patient meets criteria for an eating disorder, s/he will be referred to treatment. Participants will be randomly assigned to one of two groups using the coin flipper function available at www.random.org. All files will be password protected to prevent unauthorized access of data.