Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes (CBTeX)

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Depression; Glucose Metabolism Disorders; Mood Disorders; Insulin Resistance; Hyperinsulinism; Metabolic Disease; Mental Disorder in Adolescence
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy followed by Exercise Training; Behavioral: Exercise Training followed by Cognitive-Behavioral Therapy; Behavioral: Cognitive-Behavioral Therapy Only; Behavioral: Exercise Training Only

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren B Shomaker, PhD; Phone Number: 970-491-3217; Email: lauren.shomaker@colostate.edu
• Study Contact Backup: Name: Madison Bristol; Phone Number: 720-777-6128; Email: madison.bristol@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80011
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Madison Bristol, MPH; Phone Number: 720-777-6607; Email: madison.bristol@childrenscolorado.org
    • Fort Collins, Colorado, United States, 80523
      • Recruiting
      • Colorado State University
      • Contact: Natalia Sanchez, MPH; Phone Number: 970-491-1120; Email: natalia.sanchez@colostate.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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
• Regular medication use affecting mood, insulin, or weight, including stimulants, anti-depressants, anti-psychotics, insulin sensitizers, weight loss medications & chronic steroids
• Regular psychotherapy, structured weight loss treatment, or bariatric surgery
• Pregnancy, nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Cognitive-Behavioral Therapy followed by Exercise Training; 6-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.; Other Names: CBT->Exercise Training
Active Comparator: 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	Behavioral: Exercise Training followed by Cognitive-Behavioral Therapy; 6-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.; Other Names: Exercise Training -> CBT
Active Comparator: Exercise Training 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	Behavioral: Cognitive-Behavioral Therapy Only; 6-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.; Other Names: CBT Only
Active Comparator: Cognitive-Behavioral Therapy 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	Behavioral: Exercise Training Only; 6-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Resistance	Homeostatic model assessment of insulin resistance (HOMA-IR) estimated from fasting insulin and glucose as part of oral glucose tolerance testing	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity	Insulin sensitivity index (ISI) derived from fasting and two-hour insulin and glucose as part of oral glucose tolerance testing	1-year
Cardiorespiratory fitness	Maximum volume of oxygen (VO2 peak) during cycle ergometry testing using a graded protocol to exertion	1-year
Rate Perceived Exertion	Adolescent report on the Borg Scale during cycle ergometry testing	1-year
Exercise enjoyment	Adolescent report on the Physical Activity Enjoyment Scale (PACES), total score	1-year
Exercise self-efficacy	Adolescent report on the Exercise Self-Confidence Survey, total score	1-year
Exercise perceived capability	Adolescent report on the Physical Activity, Patient-Reported outcome Measurement Information System (PROMIS) Short Form	1-year
Depression symptoms	Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score	1-year
Depressive disorder	Schedule for Affective Disorders and Schizophrenia for School-Aged Youth - Computerized Version (KSADS-COMP) interview with adolescent	1-year
Eating behavior	Habitual macronutrient/food group intake reported 3 days (2 weekdays, 1 weekend) on the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24)	1-year
Sleep quality	Adolescent report on the Pittsburgh Sleep Quality Index, total score	1-year
Sleep disturbance	Adolescent report on the Insomnia Severity Index, total score	1-year
BMI	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	1-year
Adiposity	Fat/fat-free mass measured via air displacement plethysmography in a fasted state (BodPod)	1-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dispositional mindfulness	Adolescent report on the Mindful Attention Awareness Scale - Adolescent Version (MAAS-A), total score	1-year
Weight bias internalization	Adolescent report on the Weight Bias Internalization Scale for Youth (WBIS-Y), total score	1-year
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.	1-year
Automatic thoughts	Adolescent report of frequency of negative and positive thoughts on the Automatic Thoughts Questionnaire (ATQ), negative and positive scale scores	1-year
Pleasant activities	Adolescent report on the frequency and perceived pleasantness of physical and social activities on the Pleasant Events Schedule (PES), frequency and pleasantness scales for physical activities and for social activities	1-year
Intervention Acceptability	Equal or greater than 80% adolescent liking/credibility ratings (equal or greater than 4 on a scale of 1=not at all to 5=extremely) on a Program Acceptability Questionnaire and themes indicative of liking/perceived benefit on standardized interviews for qualitative coding	1-year

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: University of Colorado, Denver; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Exercise Training; Adolescent Type 2 Diabetes Prevention
• Additional Relevant MeSH Terms: Endocrine System Diseases; Diabetes Mellitus; Depressive Disorder; Diabetes Mellitus, Type 2; Mental Disorders; Insulin Resistance; Hyperinsulinism; Mood Disorders; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: 22-0180; 1R01DK132557-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No