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Lifestyle Counseling and Medication for Adolescent Weight Management
Recruiting
This study will compare the effectiveness and durability of intensive behavioral counseling vs. medical management plus low-intensity behavioral counseling on BMI, body fat, cardiometabolic risk factors, and quality of life in adolescents with severe obesity. We hypothesize that Wegovy (semaglutide) plus low-intensity behavioral counseling will elicit superior reductions in BMI (primary efficacy endpoint) and body fat and greater improvements in cardiometabolic risk factors and quality of life compared to intensive behavioral counseling at 56 weeks.
Up to 18 years old
Inclusion Criteria:
• ages 12-17
• BMI greater than or equal to the 95th percentile for age and sex
Exclusion Criteria:
• Type 1 or Type 2 diabetes
• use of medications for obesity in the past 6 months
• any treatment with growth hormone
• bariatric surgery -major mental health diagnosis (study staff will review)
• pregnant or plan to become pregnant
• significant medical diagnosis (study staff will review)
Children's Health, Diabetes & Endocrine
Obesity, Overweight, weight loss
Nina Jacobs - njacobs@umn.edu
Aaron Kelly
PHASE2
STUDY00012932
33826
See this study on ClinicalTrials.gov