Promoting Healthy Children and Youth

University of Minnesota (UMN)

Status and phase: Begins enrollment in 10 months; Phase 4

Conditions: Obesity, Childhood

Treatments: Drug: Semaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT06977438

PEDS-2025-33936

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,020 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 12 to < 18 years at screening
• BMI >/= 95th percentile based on age and sex

Exclusion criteria

• Diabetes (type 1 or 2) due to safety concerns about properly surveiling glycemic control virtually
• Current or recent (< 6 months prior to screening) use of obesity medications
• Previous metabolic/bariatric surgery
• Current or recent (< 6 months prior to screening) use of medication(s) to treat insulin resistance
• Hypertension
• Hypercholesterolemia
• History of treatment with growth hormone
• Eating disorder diagnosis
• Major psychiatric disorder
• Unstable clinically-diagnosed depression
• History of suicide attempt
• History of suicidal ideation or self-harm within 30 days of screening
• Current pregnancy or plans to become pregnant
• Tobacco use
• Uncontrolled hypertension
• Diagnosis of monogenic obesity
• History of cholelithiasis without cholecystectomy
• Untreated thyroid disorder
• History of pancreatitis
• Personal/family history of medullary thyroid carcinoma and/or multiple endocrine neoplasia type 2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,020 participants in 3 patient groups

High Dose HBLT

Experimental group

Description:

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.

Treatment:

Drug: Semaglutide

Medium Dose HBLT

Experimental group

Description:

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.

Treatment:

Drug: Semaglutide

Low Dose HBLT

Experimental group

Description:

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.

Treatment:

Drug: Semaglutide