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Insulin ResistanceCBTeXNCT05543083

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

A study testing Cognitive-Behavioral Therapy followed by Exercise Training, Exercise Training followed by Cognitive-Behavioral Therapy and Cognitive-Behavioral Therapy Only in people with Insulin Resistance and Depression, run by Colorado State University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 17 years, women onlyHealthy volunteers can take part
What is being tested?
Cognitive-Behavioral Therapy followed by Exercise Training, Exercise Training followed by Cognitive-Behavioral Therapy and Cognitive-Behavioral Therapy Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesUnited States
Study dates
2 Jun 2023to 31 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting
  • Children's Hospital Colorado

    Aurora, Colorado, 80011

    Madison Bristol, MPH, 720-777-6607, madison.bristol@childrenscolorado.org

    Recruiting
  • Colorado State University

    Fort Collins, Colorado, 80523

    Natalia Sanchez, MPH, 970-491-1120, natalia.sanchez@colostate.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Cognitive-Behavioral Therapy followed by Exercise Training, Exercise Training followed by Cognitive-Behavioral Therapy, Cognitive-Behavioral Therapy Only, Exercise Training Only
Keywords
Adolescent Type 2 Diabetes Prevention, Exercise Training
Medical subject headings
Insulin Resistance, Depression, Depressive Disorder, Mood Disorders, Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-Behavioral Therapy followed by Exercise TrainingBehavioural

    Also called CBT->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.

  • Exercise Training followed by Cognitive-Behavioral TherapyBehavioural

    Also called Exercise Training -> CBT

    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.

  • Cognitive-Behavioral Therapy OnlyBehavioural

    Also called CBT 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.

  • Exercise Training OnlyBehavioural

    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.

Study groups in NCT05543083
Study groupRoleWhat they receive
Cognitive-Behavioral Therapy followed by Exercise TrainingExperimental6-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
Receives: Behavioral: Cognitive-Behavioral Therapy followed by Exercise Training
Exercise Training followed by Cognitive-Behavioral TherapyActive 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
Receives: Behavioral: Exercise Training followed by Cognitive-Behavioral Therapy
Exercise Training OnlyActive 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
Receives: Behavioral: Cognitive-Behavioral Therapy Only
Cognitive-Behavioral Therapy OnlyActive 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
Receives: Behavioral: Exercise Training Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin Resistance

    Homeostatic model assessment of insulin resistance (HOMA-IR) estimated from fasting insulin and glucose as part of oral glucose tolerance testing

    Measured: 1-year

Secondary outcomes (13)
  1. Insulin sensitivity

    Insulin sensitivity index (ISI) derived from fasting and two-hour insulin and glucose as part of oral glucose tolerance testing

    Measured: 1-year

  2. Cardiorespiratory fitness

    Maximum volume of oxygen (VO2 peak) during cycle ergometry testing using a graded protocol to exertion

    Measured: 1-year

  3. Rate Perceived Exertion

    Adolescent report on the Borg Scale during cycle ergometry testing

    Measured: 1-year

  4. Exercise enjoyment

    Adolescent report on the Physical Activity Enjoyment Scale (PACES), total score

    Measured: 1-year

  5. Exercise self-efficacy

    Adolescent report on the Exercise Self-Confidence Survey, total score

    Measured: 1-year

  6. Exercise perceived capability

    Adolescent report on the Physical Activity, Patient-Reported outcome Measurement Information System (PROMIS) Short Form

    Measured: 1-year

  7. Depression symptoms

    Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score

    Measured: 1-year

  8. Depressive disorder

    Schedule for Affective Disorders and Schizophrenia for School-Aged Youth - Computerized Version (KSADS-COMP) interview with adolescent

    Measured: 1-year

  9. 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)

    Measured: 1-year

  10. Sleep quality

    Adolescent report on the Pittsburgh Sleep Quality Index, total score

    Measured: 1-year

  11. Sleep disturbance

    Adolescent report on the Insomnia Severity Index, total score

    Measured: 1-year

  12. 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

    Measured: 1-year

  13. Adiposity

    Fat/fat-free mass measured via air displacement plethysmography in a fasted state (BodPod)

    Measured: 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start2 Jun 2023
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05543083
Sponsor's protocol ID
22-0180
Other IDs
1R01DK132557-01
Acronym
CBTeX
Status last verified
Apr 2026
First submitted
24 Aug 2022
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gutierrez-Colina AM, Neiser A, Aichele S, Velasco P, B Goldschmidt A, Lavender JM, Dailey R, Sanchez N, Kelsey MM, Shomaker LB. Evaluating temporal associations between executive functioning, stress and physical activity among adolescents at risk for type 2 diabetes: protocol for an ecological momentary assessment study. BMJ Open. 2026 Aug 28;16(8):e116178. doi: 10.1136/bmjopen-2025-116178.

    PubMed 42665352

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-Behavioral Therapy followed by Exercise Training, Exercise Training followed by Cognitive-Behavioral Therapy and Cognitive-Behavioral Therapy Only in people with Insulin Resistance and Depression, run by Colorado State University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lauren B Shomaker, PhD (970-491-3217, lauren.shomaker@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin Resistance (time frame: 1-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05543083, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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