Cognitive-behavioral therapy and exercise training for teenage girls at risk for type 2 diabetes
Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
NA · Colorado State University · NCT05543083
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | Female |
| Sponsor | Colorado State University (other) |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT05543083 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using combined psychological and physical interventions for diabetes prevention, but this specific approach in adolescents is relatively novel.
Eligibility criteria
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 this trial is running
Aurora, Colorado and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insulin Resistance, Depression, Depressive Disorder, Mood Disorders, Mental Disorder in Adolescence, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Disease