Actively Recruiting
Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
Led by Colorado State University ยท Updated on 2026-04-22
300
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
Sponsors
C
Colorado State University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating ways to prevent type 2 diabetes in teenage girls who are at risk, particularly focusing on those with elevated depression symptoms. The study compares cognitive-behavioral therapy (CBT), exercise training, and combinations of these treatments to see if they can reduce stress, improve mood, increase physical activity and fitness, and decrease insulin resistance. This is important because adolescent-onset type 2 diabetes can progress more aggressively, and depression can worsen insulin resistance and reduce exercise adherence. The study includes four groups of adolescent females aged 12 to 17 at risk for type 2 diabetes with elevated depression. Each group will participate in 6-week sessions of CBT or exercise training, either alone or followed by the other intervention for another 6 weeks, totaling 12 weeks. Each session lasts 1 hour per week, and participants are assigned home practice throughout the intervention period. Participants will attend weekly group sessions and be assessed over a 1-year period. Researchers will measure insulin resistance, insulin sensitivity, fitness levels, exercise enjoyment and self-efficacy, depression symptoms, eating behaviors, sleep quality, body mass index, and adiposity. These evaluations help understand how the treatments affect depression, physical activity, and diabetes risk. The study is randomized and single-blind, with ongoing monitoring and follow-up to evaluate long-term outcomes.
CONDITIONS
Brief Title
Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 12 to 17 years
- Body Mass Index (BMI) at or above the 85th percentile for age and sex
- Have a first- or second-degree relative with type 2 diabetes
- Center for Epidemiologic Studies Depression Scale (CES-D) total score of 21 or higher
You will not qualify if you...
- Diagnosed with type 1 or type 2 diabetes or any major medical condition that prevents exercise training
- Diagnosed with conduct disorder, substance abuse or dependence, obsessive compulsive disorder, panic attacks, post-traumatic stress disorder, anorexia, bulimia, or schizophrenia
- Currently using insulin sensitizers, weight loss medications, or chronic steroids
- Undergoing structured weight loss treatment or bariatric surgery
- Pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either cognitive-behavioral therapy, exercise training, or a sequence of both interventions in group sessions to reduce depression and improve insulin resistance.
Weekly visits (1 hour each) for 12 weeks
Duration - Up to 1 year
Participants are monitored for changes in insulin resistance and related health outcomes up to one year after completing the intervention.
Periodic visits during the 1-year follow-up
Trial Site Locations
Total: 2 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80011
Actively Recruiting
2
Colorado State University
Fort Collins, Colorado, United States, 80523
Actively Recruiting
Research Team
L
Lauren B Shomaker, PhD
M
Madison Bristol
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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