GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06977438
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Obesity, Childhood

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    All participants in this study will receive treatment with Semaglutide

Study Details

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 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.

Key Dates

Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2032

Study Design

Enrollment
1,020 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: High Dose HBLT
    Individuals in this group will be randomized to receive high dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with detailed education, skill building and strategies on specific topics in addition to individual goal setting sessions.
  • Experimental: Medium Dose HBLT
    Individuals in this group will be randomized to receive medium dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with condensed information, skill building and strategies in addition to individual goal setting sessions.
  • Experimental: Low Dose HBLT
    Individuals in this group will be randomized to receive low dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with a brief overview of topics in addition to individual goal setting sessions.

Primary Outcome Measure

Body Mass Index (BMI) Reduction [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota, Center for Pediatric Obesity MedicineMinneapolisMinnesota55414
Cameron Naughton
[email protected]
612-625-3623
Aaron S Kelly, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Minneapolis, MN

By research site
University of Minnesota, Center for Pediatric Obesity Medicine· Minneapolis, MN

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