Promoting Healthy Children and Youth

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 (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.

Key Dates

Start date
Jan 1, 2027
Status verified
Feb 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 in an open fashion to receive 26 hours of HBLT during the course of the study. Participants will have HBLT every two weeks during the study which will entail 45 minute virtual group classes with a 15 minute individual goal setting session.
  • Experimental: Medium Dose HBLT
    Individuals in this group will be randomized in an open fashion to receive 13 hours of HBLT during the course of the study. Participants will have HBLT every four weeks during the study which will entail 45 minute virtual group classes with a 15 minute individual goal setting session.
  • Experimental: Low Dose HBLT
    Individuals in this group will be randomized in an open fashion to receive 4 hours of HBLT during the course of the study. Participants will have HBLT at four timepoints during the study (Weeks 2, 18, 34 and 50) which will entail 45 minute virtual group classes with a 15 minute individual goal setting session.

Primary Outcome Measure

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

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