Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
- Conditions
- DepressionDepressive DisorderMetabolic DiseaseInsulin ResistanceMood DisordersHyperinsulinismGlucose Metabolism DisordersMental Disorder in Adolescence
- Interventions
- Behavioral: Cognitive-Behavioral Therapy OnlyBehavioral: Cognitive-Behavioral Therapy followed by Exercise TrainingBehavioral: Exercise Training followed by Cognitive-Behavioral TherapyBehavioral: Exercise Training Only
- Registration Number
- NCT05543083
- Lead Sponsor
- Colorado State University
- 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.
- Detailed Description
There has been rapid escalation in adolescent-onset type 2 diabetes (T2D), particularly in females from historically disadvantaged racial/ethnic groups. Prevention is critical because adolescent-onset T2D often shows a more aggressive disease course than adult-onset, and effective treatment options remain elusive. Standard-of-care for T2D prevention includes exercise training to ameliorate insulin resistance, a key physiological precursor to T2D. Despite short-term benefits, exercise training shows insufficient effectiveness in adolescents at-risk for T2D. Depression may be explanatory in a considerable subset of teenagers. Adolescence is notable for increases in depression and decreases in physical activity, especially in females with obesity. Youths' depression symptoms contribute to worsening insulin resistance over time, independent of BMI (kg/m2), likely through stress-mediated pathways such as reduced physical activity and fitness. Also, adolescent depression is associated with decreased physical activity and cardiorespiratory fitness, even after accounting for adiposity, and depression predicts greater non-adherence to exercise training. The central theme of this proposal is that an intervention sequence of delivering cognitive-behavioral therapy (CBT) first, followed by intervening with exercise training second, will offer a targeted, efficacious strategy for improving insulin resistance and consequently, lowering T2D risk in adolescent females at-risk for T2D with depression symptoms. In a prior National Institute of Health (NIH) /National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) K99/R00 randomized controlled trial (RCT), the investigators found that 6-week group CBT decreased depression at 6-week follow-up in adolescent females at-risk for T2D with moderately elevated depression, compared to a 6-week didactic health education control group. Adolescents with elevated depression who were randomized to CBT had lower fasting and 2-hour insulin at 1-year vs. controls. Our preliminary data suggest that CBT's focus on enhancing frequency/enjoyment of physical activity to combat depressed mood partially explained why decreasing depression lowered T2D risk. It is not known if CBT is just as efficacious as standard-of-care exercise training, or whether CBT followed by exercise training results in a maximally potent alleviation of T2D risk in adolescent females at-risk for T2D with depression symptoms. To address these gaps and directly build on our prior work, the investigators propose a four-arm RCT to: (1) Compare the efficacy of four 6-week--\>6-week sequences for improving insulin resistance in N=300 adolescent females at-risk for T2D with elevated depression symptoms: (i) CBT--\>exercise, (ii) exercise--\>CBT, (iii) CBT only (CBT--\>continue CBT), and (iv) exercise only (exercise--\>continue exercise); (2) Evaluate physical activity/fitness as mediators underlying the depression-insulin resistance association; and (3) Evaluate underlying mechanisms by which decreasing depression increases physical activity and improves fitness and insulin resistance using a mixed-methods process evaluation. Findings will support our long-term goal to identify feasible, cost-effective intervention strategies with high potential for effective dissemination to adolescents at-risk for T2D with elevated depression symptoms.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Training Only Cognitive-Behavioral Therapy Only 6-week exercise training intervention of 6 weekly 1-hour group sessions followed by an additional 6-week exercise training intervention of 6 weekly 1-hour group sessions Cognitive-Behavioral Therapy followed by Exercise Training Cognitive-Behavioral Therapy followed by Exercise Training 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions followed by a 6-week exercise training intervention of 6 weekly 1-hour group sessions Exercise Training followed by Cognitive-Behavioral Therapy Exercise Training followed by Cognitive-Behavioral Therapy 6-week exercise training intervention of 6 weekly 1-hour group sessions followed by a 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions Cognitive-Behavioral Therapy Only Exercise Training Only 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions followed by an additional 6-week cognitive-behavioral therapy intervention of 6 weekly 1-hour group sessions
- Primary Outcome Measures
Name Time Method Insulin Resistance 1-year Homeostatic model assessment of insulin resistance (HOMA-IR) estimated from fasting insulin and glucose as part of oral glucose tolerance testing
- Secondary Outcome Measures
Name Time Method Eating behavior 1-year Habitual macronutrient/food group intake reported 3 days (2 weekdays, 1 weekend) on the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)
Insulin sensitivity 1-year Insulin sensitivity index (ISI) derived from fasting and two-hour insulin and glucose as part of oral glucose tolerance testing
Rate Perceived Exertion 1-year Adolescent report on the Borg Scale during cycle ergometry testing
Exercise enjoyment 1-year Adolescent report on the Physical Activity Enjoyment Scale (PACES), total score
Exercise perceived capability 1-year Adolescent report on the Physical Activity, Patient-Reported outcome Measurement Information System (PROMIS) Short Form
Depression symptoms 1-year Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score
Adiposity 1-year Fat/fat-free mass measured via air displacement plethysmography in a fasted state (BodPod)
Cardiorespiratory fitness 1-year Maximum volume of oxygen (VO2 peak) during cycle ergometry testing using a graded protocol to exertion
Exercise self-efficacy 1-year Adolescent report on the Exercise Self-Confidence Survey, total score
Sleep quality 1-year Adolescent report on the Pittsburgh Sleep Quality Index, total score
BMI 1-year Derived from height in triplicate by stadiometer and fasting weight by calibrated scale; raw (kg/m2) and z-score/percentile based upon Centers for Disease Control and Prevention (CDC) growth charts
Depressive disorder 1-year Schedule for Affective Disorders and Schizophrenia for School-Aged Youth - Computerized Version (KSADS-COMP) interview with adolescent
Sleep disturbance 1-year Adolescent report on the Insomnia Severity Index, total score
Trial Locations
- Locations (2)
Colorado State University
🇺🇸Fort Collins, Colorado, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States