Cognitive-behavioral therapy and exercise training for teenage girls at risk for type 2 diabetes
Official title: Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
Run by Colorado State University · NCT05543083 · Data updated 2026-11-12
This study is testing if cognitive-behavioral therapy, exercise training, or both can help teenage girls at risk for type 2 diabetes improve their health and reduce stress and depression.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 17 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Colorado State University Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Status | Recruiting |
| Started | June 2, 2023 |
| Main results expected | December 31, 2028 |
| Study ends | March 31, 2029 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT05543083 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are females aged 12-17 years with a BMI at or above the 85th percentile for their age and sex, and a family history of type 2 diabetes.
✕Probably not a fit
Patients with existing type 1 or type 2 diabetes, major medical conditions, or certain mental health disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to prevent type 2 diabetes in teenage girls by evaluating the effectiveness of cognitive-behavioral therapy (CBT), exercise training, or a combination of both. The researchers will assess how these interventions impact stress levels, mood, physical activity, fitness, and insulin resistance among participants. The study focuses on adolescents from historically disadvantaged racial/ethnic groups who are at risk for diabetes due to obesity and depression. By implementing a sequential intervention approach, the study seeks to provide a targeted strategy for improving health outcomes in this population.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of type 2 diabetes in adolescent girls by addressing both mental health and physical fitness.
How similar studies have gone: Other studies have shown promise in using combined psychological and physical interventions for diabetes prevention, but this specific approach in adolescents is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age 12-17 years * Body Mass Index (BMI)\>= 85 for age and sex * Type 2 Diabetes (T2D) first-or second-degree relative * Center for Epidemiologic Studies Depression Scale (CES-D) total score \>=21 Exclusion Criteria: * T2D/ Type 1 Diabetes (T1D) or any major medical condition (e.g. cardiovascular, renal) that would prohibit the ability to participate in exercise training * Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) conduct disorder, substance abuse/ dependence, obsessive compulsive disorder, panic attacks, post-traumatic stress disorder, anorexia/bulimia, \& schizophrenia * Insulin sensitizers, weight loss medications \& chronic steroids * Structured weight loss treatment or bariatric surgery * Pregnancy, nursing
Where it's running
-
Children's Hospital Colorado
Aurora, Colorado, United States Recruiting -
Colorado State University
Fort Collins, Colorado, United States Recruiting
Study contacts
- Study coordinator: Lauren B Shomaker, PhD
- Email: lauren.shomaker@colostate.edu
- Phone: 970-491-3217
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.