Clinical trial NCT05543083: Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
Official title: Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Resistance
Depression
Depressive Disorder
Mood Disorders
Mental Disorder in Adolescence
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Disease
Keywords: Adolescent Type 2 Diabetes Prevention
Exercise Training
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Colorado, Denver
First posted: 2022-09-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Insulin Resistance
timeFrame: 1-year
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: 1-year
measure: Cardiorespiratory fitness
timeFrame: 1-year
measure: Rate Perceived Exertion
timeFrame: 1-year
measure: Exercise enjoyment
timeFrame: 1-year
measure: Exercise self-efficacy
timeFrame: 1-year
measure: Exercise perceived capability
timeFrame: 1-year
measure: Depression symptoms
timeFrame: 1-year
measure: Depressive disorder
timeFrame: 1-year
measure: Eating behavior
timeFrame: 1-year
measure: Sleep quality
timeFrame: 1-year
measure: Sleep disturbance
timeFrame: 1-year
measure: BMI
timeFrame: 1-year
measure: Adiposity
timeFrame: 1-year
Other outcomes:
measure: Dispositional mindfulness
timeFrame: 1-year
measure: Weight bias internalization
timeFrame: 1-year
measure: Body image
timeFrame: 1-year
measure: Automatic thoughts
timeFrame: 1-year
measure: Pleasant activities
timeFrame: 1-year
measure: Intervention Acceptability
timeFrame: 1-year
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
References: