About this trial
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
This trial accepts healthy volunteersQualifiers
Female
Age 12-17 years
Body Mass Index (BMI)>= 85 for age and sex
Type 2 Diabetes (T2D) first-or second-degree relative
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Cognitive-Behavioral Therapy followed by Exercise Training
Behavioral6-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
Behavioral6-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
Behavioral6-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
Behavioral6-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.
Treatment groups
Trial outcomes
Primary outcomes
Insulin Resistance
Homeostatic model assessment of insulin resistance (HOMA-IR) estimated from fasting insulin and glucose as part of oral glucose tolerance testing
Secondary outcomes
Insulin sensitivity
Insulin sensitivity index (ISI) derived from fasting and two-hour insulin and glucose as part of oral glucose tolerance testing
Cardiorespiratory fitness
Maximum volume of oxygen (VO2 peak) during cycle ergometry testing using a graded protocol to exertion
Rate Perceived Exertion
Adolescent report on the Borg Scale during cycle ergometry testing
Exercise enjoyment
Adolescent report on the Physical Activity Enjoyment Scale (PACES), total score
Other outcomes
Dispositional mindfulness
Adolescent report on the Mindful Attention Awareness Scale - Adolescent Version (MAAS-A), total score
Weight bias internalization
Adolescent report on the Weight Bias Internalization Scale for Youth (WBIS-Y), total score
Body image
Multidimensional Body Self-Relations Questionnaire Measure composed of 10 subscales: appearance evaluation, fitness evaluation, fitness orientation, health evaluation, health orientation, illness orientation, body areas satisfaction, overweight preoccupation, and self-classified weight.
Automatic thoughts
Adolescent report of frequency of negative and positive thoughts on the Automatic Thoughts Questionnaire (ATQ), negative and positive scale scores
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Colorado State University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Colorado, Denver
Collaborator