Promoting Healthy Children and Youth

NCT06977438 · Not yet recruiting

Last updated 2026-05-28

This trial tests a program to help children and teens with obesity improve their health by reducing their Body Mass Index (BMI).

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 1,020 people Planned (estimated).

Who can join Ages 12–18 · all sexes

Timeline Started 2027-01 · est. completion 2032-01

What this study is testing ClinicalTrials.gov NCT06977438 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semaglutide Drug

All participants in this study will receive treatment with Semaglutide

Main thing measured	Body Mass Index (BMI) Reduction
Sponsor	University of Minnesota
Conditions studied	Obesity, Childhood
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06977438 ↗