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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Novo Nordisk A/S | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose HBLT | Experimental | 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. |
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| Medium Dose HBLT | Experimental | 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. |
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| Low Dose HBLT | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | All participants in this study will receive treatment with Semaglutide |
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| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) Reduction | Change in body mass index | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawn Nederhoff | Contact | 612-626-2349 | epper019@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aaron Kelly, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota, Center for Pediatric Obesity Medicine | Minneapolis | Minnesota | 55414 | United States |
Results will be available through the Patient Centered Outcomes Data Repository (PCODR)
Data will be shared after the Patient Centered Outcomes Research Institute (PCORI) accepts the Final Research Report following peer review. As set forth in PCORI's Data Sharing Policy, study data will be available for third-party requests when one of two conditions is met (whichever is met first):
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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The investigator, participant and the study coordinator will be blinded to the HBLT treatment. Only the dietitians and study monitor will know the HBLT treatment assignments of the participants.
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |