Comparison of Intensive Behavioral Counseling vs. Medical Management to Treat Adolescent Severe Obesity

点击翻译按钮获取中文摘要

Abstract The prevalence of adolescent severe obesity is at an all-time high in the U.S. (~8%), and the refractory nature of this disease has led to uncertainty regarding how to provide effective, safe, scalable, and durable treatments without placing undue strain on the healthcare system. In 2017, the U.S. Preventive Services Task Force (USPSTF) released updated screening recommendations concluding that comprehensive, intensive behavioral interventions with a total of ≥26 contact hours over a period of 2-12 months resulted in weight loss in youth with obesity, with ≥52 contact hours leading to even greater weight loss and improvements in some cardiometabolic risk factors. However, the practicality of delivering these types of intensive behavioral services to the millions of youth with severe obesity in the U.S. is debatable not only because of the treatment-resistant nature of severe obesity, but also the time-commitment, acceptability, and sustainability of this approach for patients and their families and the extensive resources required to offer these interventions. While behavior change is an indispensable component of any effective weight loss approach, adjunctive strategies such as pharmacotherapy may enhance health outcomes. Pharmacotherapy combined with relatively low-intensity behavioral counseling (<26 contact hours) represents a potentially effective, durable, and safe treatment strategy for this population. This approach may be more practical and feasible to implement on a broad scale, preferred by patients and families, utilize fewer healthcare resources, and cost less to deliver compared to comprehensive, intensive behavioral interventions. We propose a two-arm, randomized clinical trial in adolescents with severe obesity evaluating two years of comprehensive, intensive behavioral counseling, aligned with the USPSTF report (52 contact hours during year one; 26 contact hours during year two), vs. two years of medical management with liraglutide plus relatively low-intensity behavioral counseling (12 contact hours during year one; six contact hours during year two). Outcomes will include weight loss effectiveness and durability, cardiometabolic risk factor improvements, quality of life, safety, and implementation feasibility.