NCT05543083 Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
| NCT ID | NCT05543083 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Colorado State University |
| Condition | Insulin Resistance |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-06-02 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-06-02 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05543083 clinical trial?
This trial is open to female participants only, aged 12 Years or older, up to 17 Years, studying Insulin Resistance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05543083 currently recruiting?
Yes, NCT05543083 is actively recruiting participants. Contact the research team at lauren.shomaker@colostate.edu for enrollment information.
Where is the NCT05543083 trial being conducted?
This trial is being conducted at Aurora, United States, Fort Collins, United States.
Who is sponsoring the NCT05543083 clinical trial?
NCT05543083 is sponsored by Colorado State University. The trial plans to enroll 300 participants.