Lifestyle Counseling and Medication for Adolescent Weight Management

What this study is testing ClinicalTrials.gov NCT04873245 ↗

Description as written by the study sponsor.

The prevalence of adolescent severe obesity is at an all-time high in the United States and the refractory nature of this disease has led to a serious and challenging conundrum in terms of how to provide effective, safe, scalable, and durable treatments without placing undue strain on the healthcare system. Clinical practice guidelines recommend behavioral interventions as the primary strategy for all ages and classes of obesity - moderate to severe. 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 due to the time-commitment, acceptability, and sustainability of this approach for adolescent patients and their families along with the extensive resources required to provide these interventions. Indeed, fewer than 50% of pediatric patients referred for weight management services enroll in treatment, and high attrition rates of up to 50% have been reported in behavioral-based clinical trials and in the clinical setting. Moreover, adherence to behavioral counseling significantly diminishes over time, which too often erodes early weight loss success and ultimately derails durability. The reality of what most patients/families are able to do and the unique physiological and psychosocial features of severe obesity in adolescence do not seem to align well with the degree of intensity of behavioral interventions shown to be effective by the USPSTF. Therefore, a critical appraisal of the feasibility, effectiveness, and sustainability of the USPSTF recommendations among adolescents with severe obesity is warranted. While behavior change is an indispensable component of any effective weight loss approach, adjunctive strategies such as pharmacotherapy may enhance outcomes in adolescents with severe obesity. Many maladaptive behaviors attributed to obesity are driven by underlying biological forces, such as increased appetite and food palatability, that are largely beyond the control of the individual. Pharmacotherapy can help facilitate behavior change by disrupting core pathophysiological processes and restoring homeostasis to the energy regulatory system, therein enabling individuals to sustain healthy behavior change. Though under-explored as a treatment for adolescent obesity, pharmacotherapy along with relatively low-intensity behavioral counseling (\<26 contact hours) represents a potentially effective, durable, and safe treatment strategy. This approach may be more practical and feasible to implement on a broad scale, be preferred by patients/families, utilize fewer healthcare resources, and cost less to deliver compared to comprehensive, intensive behavioral interventions.

Treatments tested

• Intensive Behavioral Program Behavioral

  Participants randomized to this group will receive intensive behavioral therapy.

• Semaglutide and Behavioral Program Drug

  Participants randomized to this group will receive semaglutide and behavioral therapy.