Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes
CBTeX
2 other identifiers
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
September 16, 2022
CompletedStudy Start
First participant enrolled
June 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
April 22, 2026
April 1, 2026
5.6 years
August 24, 2022
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Insulin sensitivity
1-year
Cardiorespiratory fitness
1-year
Rate Perceived Exertion
1-year
Exercise enjoyment
1-year
Exercise self-efficacy
1-year
- +8 more secondary outcomes
Other Outcomes (6)
Dispositional mindfulness
1-year
Weight bias internalization
1-year
Body image
1-year
- +3 more other outcomes
Study Arms (4)
Cognitive-Behavioral Therapy followed by Exercise Training
EXPERIMENTAL6-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
ACTIVE COMPARATOR6-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
Exercise Training Only
ACTIVE COMPARATOR6-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 Only
ACTIVE COMPARATOR6-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
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Hospital Colorado
Aurora, Colorado, 80011, United States
Colorado State University
Fort Collins, Colorado, 80523, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
September 16, 2022
Study Start
June 2, 2023
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
March 31, 2029
Last Updated
April 22, 2026
Record last verified: 2026-04