Promoting Healthy Children and Youth

Launched by UNIVERSITY OF MINNESOTA · May 9, 2025

Keywords

ClinConnect Summary

This clinical trial, called "Promoting Healthy Children and Youth," is exploring how effective different levels of health behavior and lifestyle treatment (HBLT) are for teenagers struggling with obesity. Researchers want to find out if spending a lot of time (more than 26 hours) on HBLT is necessary, or if a shorter, less intensive approach can also help improve things like weight, quality of life, and heart health. This is important because new obesity medications are becoming available, and many people are curious about how lifestyle changes fit into treatment plans.

To participate, teens aged 12 to under 18 years who have a body mass index (BMI) in the 95th percentile or higher may be eligible. However, there are some health conditions that would prevent participation, such as having diabetes, recent use of obesity medications, or certain mental health issues. If selected, participants can expect to engage in HBLT sessions that could help them learn healthier habits and potentially improve their overall well-being. This trial aims to provide valuable insights for families and healthcare providers on the best ways to support teens with obesity.

Gender

ALL

Eligibility criteria

• 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