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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Colorado State University
Study ID
NCT05543083
Status
Recruiting
Apply to this trial

Conditions

  • Depression
  • Depressive Disorder
  • Glucose Metabolism Disorders
  • Hyperinsulinism
  • Insulin Resistance
  • Mental Disorder in Adolescence
  • Metabolic Disease
  • Mood Disorders

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Cognitive-Behavioral Therapy followed by Exercise Training — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 2, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

Insulin Resistance [ Time Frame: 1-year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80011
Madison Bristol, MPH
[email protected]
720-777-6607
Colorado State UniversityFort CollinsColorado80523
Natalia Sanchez, MPH
[email protected]
970-491-1120

Find similar trials in Aurora, CO

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Children's Hospital Colorado· Aurora, COColorado State University· Fort Collins, CO

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