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

NCT05543083 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-22

No results posted yet for this study

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
  • Hyperinsulinism
  • Glucose Metabolism Disorders
  • Metabolic Disease

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • University of Colorado, Denver

    collaborator OTHER
  • Colorado State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2028-12-31
Completion
2029-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543083 on ClinicalTrials.gov