Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 12 Years to 17 Years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests group talk therapy, exercise training, or both to help prevent type 2 diabetes in teenage girls at risk. Researchers want to see if these programs lower stress, improve mood and fitness, increase activity, and help the body use insulin better.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Girls ages 12–17.
- BMI (a measure of weight compared with height) of at least 85 for age and sex.
- A close family member, such as a parent, sibling, grandparent, aunt, or uncle, has type 2 diabetes.
- A score of 21 or higher on the CES-D, a survey about signs of depression.
Who can't join
- Type 1 or type 2 diabetes, or a major health problem, such as heart or kidney disease, that prevents exercise training.
- A diagnosis of conduct disorder (serious behavior problems) or substance abuse or dependence.
- A diagnosis of obsessive-compulsive disorder (unwanted thoughts and repeated actions), panic attacks, or post-traumatic stress disorder (symptoms after trauma).
- A diagnosis of anorexia or bulimia (eating disorders), or schizophrenia (an illness that affects thoughts and sense of reality).
- Use of medicines that help the body respond to insulin, weight-loss medicines, or long-term steroids.
- A structured weight-loss program or weight-loss surgery.
- Pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (2)
CO
- Children's Hospital Colorado · Aurora, CO 80011Madison Bristol, MPH · Study contact · 720-777-6607 · madison.bristol@childrenscolorado.orgMore trials in Aurora
- Colorado State University · Fort Collins, CO 80523Natalia Sanchez, MPH · Study contact · 970-491-1120 · natalia.sanchez@colostate.eduMore trials in Fort Collins