NCT06977438

Promoting Healthy Children and Youth

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,020 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The rapid emergence of new and highly effective obesity medications has turned the field of pediatric weight management on its head. Adolescents living with obesity, their caregivers, healthcare providers, healthcare systems, policymakers, and payors are now wondering what role health behavior and lifestyle treatment (HBLT) has in terms of body mass index (BMI) reduction, improvements in quality of life and cardiometabolic health, and mitigating nutritional concerns when medications are used. Is intensive (26+ hours) of HBLT needed or could low intensity HBLT be an equally effective alternative; and if so, for whom? Our proposed project will answer these important questions that arise daily in the clinical setting and will generate critical new insights to guide decision-making for teens with obesity and the stakeholders who care deeply about them.

Detailed description

The premise underpinning our proposed project stems from the conceptual framework that obesity medications beneficially alter the underlying pathophysiology that largely drives eating behaviors (appetite, satiety, cravings, and "food noise"), thereby lessening the need for high doses of HBLT. In this way, medications can unburden adolescents living with obesity, their caregivers, healthcare providers, health systems, and payors from the need to engage in and provide intensive HBLT. This framework has directly informed our research strategy and methodological approach, including the design of our trial and the variables we have chosen to assess. Indeed, we plan to compare three different doses of HBLT in terms of their ability to improve health-related outcomes while having a keen eye on nutritional safety and eating disorders. The design and patient-centered outcomes for our trial have been carefully and thoughtfully crafted to provide evidence-based clarity on critical decisional dilemmas regarding how much HBLT is needed to get the most out of obesity pharmacotherapy and how social determinants of health (SDOH) factors can help guide treatment strategies to maximize effectiveness and safety.

Conditions

• Obesity, Childhood

Interventions

Type	Name	Description
DRUG	Semaglutide	All participants in this study will receive treatment with Semaglutide

Timeline

• Start date: 2027-01-01
• Primary completion: 2031-01-31
• Completion: 2032-01-31
• First posted: 2025-05-18
• Last updated: 2026-02-10

Regulatory

• FDA-regulated drug study