GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward
ConditionObesity, Childhood
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
Qualifiers
Aged 12 to < 18 years at screening
BMI >/= 95th percentile based on age and sex at screening
Provide release of information for established primary health provider
Own a device capable of connecting to the virtual platform sessions with video
Disqualifiers
Diabetes (type 1 or 2) due to safety concerns about proper surveillance of glycemic control virtually
HbA1c >/= 6.5%
Current or recent (< 6 months prior to screening) use of FDA-approved obesity medications
Previous metabolic/bariatric surgery or metabolic/bariatric surgery planned during the study period
Trial design
Treatments tested in this trial
- Semaglutide
Treatment groups
1,020 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Minnesota
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Novo Nordisk A/S
Collaborator
Source ClinicalTrials.gov