Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
FEMALE
Healthy Volunteers
ID05543083

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

Age: 12Years - 17Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

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

Follow-up

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

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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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