Recruiting

Cognitive-Behavioral Therapy, Exercise Training

Sponsor:

Colorado State University

Code:

NCT05543083

Conditions

Insulin Resistance

Depression

Depressive Disorder

Mood Disorders

Mental Disorder in Adolescence

Eligibility Criteria

Sex: Female

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

Cognitive-Behavioral Therapy followed by Exercise Training

Exercise Training followed by Cognitive-Behavioral Therapy

Cognitive-Behavioral Therapy Only

Exercise Training Only

Study Details

Brief 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.

Conditions

Insulin Resistance

Depression

Depressive Disorder

Mood Disorders

Mental Disorder in Adolescence

Study ID

NCT05543083

Start date

Jun 2, 2023

Status verified date

Apr, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cognitive-Behavioral Therapy followed by Exercise Training

6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions followed by a 6-week exercise training intervention of 6 weekly 1-hour group sessions

active comparator: Exercise Training followed by Cognitive-Behavioral Therapy

6-week exercise training intervention of 6 weekly 1-hour group sessions followed by a 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions

active comparator: Exercise Training Only

6-week exercise training intervention of 6 weekly 1-hour group sessions followed by an additional 6-week exercise training intervention of 6 weekly 1-hour group sessions

active comparator: Cognitive-Behavioral Therapy Only

6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions followed by an additional 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions

Interventions

Cognitive-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.

Exercise 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.

Cognitive-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.

Exercise 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.

Primary outcome measure

  • Insulin Resistance [ Time Frame: 1-year ]

Central Contacts and Locations

Central contacts

Lauren B Shomaker, PhD

970-491-3217lauren.shomaker@colostate.edu

Madison Bristol

720-777-6128madison.bristol@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80011

Contacts

Madison Bristol, MPH

720-777-6607madison.bristol@childrenscolorado.org

Colorado State University

Recruiting

Fort Collins, Colorado, United States, 80523

Contacts

Natalia Sanchez, MPH

970-491-1120natalia.sanchez@colostate.edu

More Information

Sponsor

Colorado State University

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Adolescent Type 2 Diabetes Prevention
  • Exercise Training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado State University on 2026-04-22.