RecruitingNot ApplicableNCT05543083

Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes


Sponsor

Colorado State University

Enrollment

300 participants

Start Date

Jun 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators are doing this study to learn more about how to prevent type 2 diabetes in teenage girls. The purpose of this study is to find out if taking part in a cognitive-behavioral therapy group, exercise training group, or a combination of cognitive-behavioral therapy and exercise training groups, decreases stress, improves mood, increases physical activity and physical fitness, and decreases insulin resistance among teenagers at risk for diabetes.


Eligibility

Sex: FEMALEMin Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of Cognitive Behavioral Therapy (CBT) — a structured form of talk therapy that targets negative thought patterns — and exercise training can improve depression and reduce Type 2 diabetes risk in teenage girls who are overweight and have a family history of diabetes. Both mental health and metabolic health are targeted together in this program. **You may be eligible if:** - You are a female between 12 and 17 years old - Your BMI is at or above the 85th percentile for your age and sex (overweight or obese range) - You have a parent, sibling, or grandparent with Type 2 diabetes - Your depression score on a standard screening scale is elevated (CES-D ≥ 21) **You may NOT be eligible if:** - You have been diagnosed with Type 1 or Type 2 diabetes, or a serious heart or kidney condition - You have certain mental health conditions that require different treatment (e.g., conduct disorder, OCD, psychosis, anorexia) - You are currently pregnant or breastfeeding - You are on weight-loss medications or have had bariatric surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive-Behavioral Therapy followed by Exercise Training

6-week group CBT (cognitive-behavioral therapy; 1 hour/week for 6 weeks) followed by 6-week group exercise training (1 hour/week for 6 weeks). Home practice is assigned throughout the 12-week intervention period.

BEHAVIORALExercise Training followed by Cognitive-Behavioral Therapy

6-week group exercise training (1 hour/week for 6 weeks) followed by 6-week group CBT (1 hour/week for 6 weeks). Home practice is assigned throughout the 12-week intervention period.

BEHAVIORALCognitive-Behavioral Therapy Only

6-week group CBT (1 hour/week for 6 weeks), with continuation of group CBT for a second 6-week period (1 hour/week for 6 weeks). Home practice is assigned throughout the 12-week intervention period.

BEHAVIORALExercise Training Only

6-week group exercise training (1 hour/week for 6 weeks), with continuation of group exercise for a second 6-week period (1 hour/week for 6 weeks). Home practice is assigned throughout the 12-week intervention period.


Locations(2)

Children's Hospital Colorado

Aurora, Colorado, United States

Colorado State University

Fort Collins, Colorado, United States

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NCT05543083


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