CBT + Exercise for Diabetes Prevention in Adolescents

(CBTeX Trial)

Recruiting at 1 trial location

Overseen By Madison Bristol

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: Colorado State University

Must not be taking: Insulin sensitizers, Steroids

Disqualifiers: Diabetes, Cardiovascular, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to prevent type 2 diabetes in teenage girls by examining the effects of cognitive-behavioral therapy (CBT) and exercise. Researchers aim to determine if these activities can lower stress, boost mood, increase physical activity, and reduce insulin resistance. Participants will be divided into groups to engage in CBT, exercise, or a combination of both over several weeks. Teenage girls aged 12-17, who are at risk for diabetes and have a family member with the condition, may be suitable candidates, particularly if they frequently experience stress or low mood. As an unphased trial, this study provides a unique opportunity to contribute to innovative research focused on improving health outcomes for at-risk teens.

Will I have to stop taking my current medications?

The trial requires that participants do not take insulin sensitizers, weight loss medications, or chronic steroids. If you are on these medications, you would need to stop them to join the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both cognitive-behavioral therapy (CBT) and exercise are generally safe and well-tolerated. Studies have found that CBT effectively helps manage diabetes without typically causing negative side effects. Evidence suggests that low- to moderate-intensity workouts are safe for most people, including those with type 2 diabetes, with a low risk of problems. Overall, both CBT and exercise are considered safe ways to improve health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the combined effects of cognitive-behavioral therapy (CBT) and exercise training to prevent diabetes in adolescents, offering a fresh approach compared to traditional methods like medication and lifestyle changes alone. CBT can help young people develop healthier behaviors and mindsets, potentially leading to better long-term adherence to healthy habits. Meanwhile, exercise training provides physical benefits essential for diabetes prevention. This dual approach could address both mental and physical aspects of diabetes risk, offering a more comprehensive prevention strategy.

What evidence suggests that this trial's treatments could be effective for preventing type 2 diabetes in adolescents?

Research shows that cognitive-behavioral therapy (CBT) can improve mental well-being and reduce diabetes-related stress. It eases symptoms of depression and health anxiety in people with diabetes. However, its direct effect on blood sugar control remains unclear. In this trial, some participants will receive only CBT, while others will receive CBT followed by exercise training.

Exercise, on the other hand, has consistently helped control blood sugar in people with prediabetes. Regular physical activity links to a lower risk of developing type 2 diabetes and benefits heart health and overall fitness. Participants in this trial may receive only exercise training or exercise training followed by CBT. Combining CBT and exercise might offer a comprehensive approach to preventing diabetes by supporting both mental and physical health. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for teenage girls aged 12-17 who are at risk for type 2 diabetes due to family history, show signs of depression, and have a higher body weight for their age. They shouldn't have diabetes or major medical conditions, mental disorders like schizophrenia or eating disorders, be on mood-altering medications, or be pregnant.

Inclusion Criteria

I am between 12 and 17 years old.

I am female.

I have a parent, sibling, or grandparent with Type 2 Diabetes.

Exclusion Criteria

I do not have major health issues that prevent me from exercising.

Pregnancy, nursing

You have been diagnosed with certain mental health conditions including conduct disorder, substance abuse/dependence, obsessive compulsive disorder, panic attacks, post-traumatic stress disorder, anorexia/bulimia, and schizophrenia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cognitive-Behavioral Therapy

Participants undergo a 6-week cognitive-behavioral therapy intervention with weekly 1-hour group sessions

6 weeks

6 visits (in-person)

Exercise Training

Participants undergo a 6-week exercise training intervention with weekly 1-hour group sessions

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy
• Exercise Training

Trial Overview

The study tests if cognitive-behavioral therapy (CBT), exercise training, or both can reduce stress and improve mood and physical fitness in teens at risk for diabetes. It aims to see if these interventions also lower insulin resistance which is linked to developing diabetes.

How Is the Trial Designed?

Group I: Cognitive-Behavioral Therapy followed by Exercise Training Experimental Treatment 1 Intervention

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

Group II: Cognitive-Behavioral Therapy Only Active Control 1 Intervention

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

Group III: Exercise Training followed by Cognitive-Behavioral Therapy Active Control 1 Intervention

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

Group IV: Exercise Training Only Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

A multi-site randomized controlled trial is being conducted with 300 adolescent females at risk for type 2 diabetes (T2D) to evaluate the effectiveness of group cognitive-behavioral therapy and group exercise training, both separately and in combination, over a total of 12 weeks.

The primary focus of the study is to assess insulin resistance, with secondary outcomes including insulin sensitivity, physical fitness, and depression symptoms, aiming to provide insights into effective prevention strategies for T2D in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy and exercise training in adolescent females with elevated depression symptoms and at-risk for type 2 diabetes: Protocol for a randomized controlled trial. Gutierrez-Colina, AM., Bristol, M., Clark, ELM., et al.[2023]

In a study involving 72 adolescent females with type I diabetes, those who engaged in 45 minutes of aerobic exercise showed significant reductions in various emotional issues, including depression and anxiety, compared to a control group that did not exercise.

The results indicate that regular exercise can positively impact the emotional well-being of adolescent females with diabetes, highlighting its potential as an effective intervention for managing emotional reactions in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of exercise on affective responses in female adolescents with type I diabetes. Talakoub, S., Gorbani, S., Hasanpour, M., et al.[2021]

A clinical trial involving 65 adolescents aged 13 to 20 showed that combining coping skills training (CST) with intensive diabetes management led to lower HbA1c levels, indicating better metabolic control compared to those receiving intensive management alone.

Participants who underwent CST reported improved self-efficacy in managing diabetes and experienced a better quality of life, suggesting that behavioral interventions can enhance both health outcomes and emotional well-being in adolescents with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of coping skills training as adjunct to intensive therapy in adolescents. Grey, M., Boland, EA., Davidson, M., et al.[2022]

The Diabetes Prevention Program (DPP) demonstrated significant success in reducing weight and decreasing the incidence of type-2 diabetes by 58% through a structured lifestyle intervention over one year, outperforming metformin medication.

The DPP's approach, which includes physical activity, diet, and behavioral strategies, has been effectively adapted for various populations, including those with disabilities, showing promising outcomes in combating obesity and related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Model Programs to Address Obesity and Cardiometabolic Disease: Interventions for Suboptimal Nutrition and Sedentary Lifestyles. Nash, MS., Kressler, J.[2018]

Regular physical activity is highly effective in preventing coronary heart disease, with strong evidence supporting its use for primary prevention and acceptable data for secondary prevention.

Public health recommendations suggest that adults should engage in at least 30 minutes of exercise daily, while children and adolescents should aim for one hour, as a response to rising obesity and sedentary lifestyles, with minimal side effects associated with physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prescription of physical activity in cardiology: classical and new indications (a review based on evidence based data)]. Delagardelle, C., Feiereisen, P.[2006]

Supervised physical training (PT) significantly improved aerobic fitness and reduced body fat in obese black girls aged 7 to 11, while lifestyle education (LSE) led to greater improvements in dietary habits and glucose levels.

Both interventions effectively improved certain risk factors for coronary artery disease and diabetes, suggesting that PT enhances physical fitness and fat loss, whereas LSE focuses on dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical training, lifestyle education, and coronary risk factors in obese girls. Gutin, B., Cucuzzo, N., Islam, S., et al.[2019]

In a study of 119 adolescent girls at risk for type 2 diabetes, those who received cognitive-behavioral therapy (CBT) showed significant decreases in depression, which in turn was linked to lower fasting insulin levels after one year.

The results suggest that reducing depression may help prevent type 2 diabetes in at-risk adolescents, particularly for those with higher initial levels of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect Effects of a Cognitive-Behavioral Intervention on Adolescent Weight and Insulin Resistance Through Decreasing Depression in a Randomized Controlled Trial. Gulley, LD., Shomaker, LB., Kelly, NR., et al.[2021]

Physical activity interventions, especially when combined with dietary changes, are more effective for treating overweight and obesity in adults than physical activity alone, although long-term success remains challenging.

For type 2 diabetes, multifactorial interventions that include diet, physical activity, and medication can lead to meaningful improvements in blood sugar control, but there is limited evidence on the effectiveness of community-based programs for sustained glycaemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of physical activity interventions for the treatment of overweight and obesity and type 2 diabetes. Miller, YD., Dunstan, DW.[2019]

Regular physical exercise is crucial for both preventing and treating type 2 diabetes, leading to benefits such as improved insulin sensitivity, better glycemic control, and enhanced cardiovascular health.

Before starting an exercise program, individuals with type 2 diabetes should undergo a thorough medical evaluation to assess their cardiovascular health and any complications, ensuring a safe and effective exercise plan that gradually increases in intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and exercise in type 2 diabetes mellitus. Hamdy, O., Goodyear, LJ., Horton, ES.[2019]

Regular physical activity significantly benefits youth with diabetes by improving their fitness, body composition, and overall health, yet many do not meet recommended activity levels.

The review introduces a new exercise management algorithm to help youth with type 1 diabetes adjust insulin and carbohydrate intake during exercise, addressing the complexities of managing diabetes while being active.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current perspectives on physical activity and exercise for youth with diabetes. Pivovarov, JA., Taplin, CE., Riddell, MC.[2015]

A systematic review of 4 studies involving children aged 6-12 years at risk for Type 2 diabetes showed that behavioral-based interventions can significantly improve weight status, with 3 out of 4 studies reporting positive outcomes.

However, the interventions did not lead to significant changes in fasting glucose, HbA1c, or cholesterol levels, indicating that while weight management is beneficial, further research is needed to understand their full impact on cardiometabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Behavioral Interventions on Children at Risk for Diabetes. Verdezoto Alvarado, A., Burns, KF., Katz, SE., et al.[2023]

A 6-week cognitive behavioral therapy (CBT) program helped reduce depressive symptoms in adolescent females at risk for type 2 diabetes, with significant improvements noted in those with moderate baseline depression.

While overall insulin sensitivity remained stable in both the CBT and health education groups, girls with moderate depressive symptoms in the CBT group showed a significant reduction in 2-hour insulin levels, suggesting potential metabolic benefits from CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of insulin resistance in adolescents at risk for type 2 diabetes with depressive symptoms: 1-year follow-up of a randomized trial. Shomaker, LB., Kelly, NR., Radin, RM., et al.[2020]

In a study of 77 adolescents starting intensive insulin therapy, those who received coping skills training (CST) showed significantly better metabolic control and self-efficacy after 6 months compared to those who did not receive CST.

Participants who underwent CST reported a reduced negative impact of diabetes on their quality of life and experienced fewer worries about their condition, suggesting that CST can be an effective behavioral intervention for improving both health outcomes and psychosocial well-being in youths with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping skills training for youths with diabetes on intensive therapy. Grey, M., Boland, EA., Davidson, M., et al.[2022]

Physical exercise plays a crucial role in disease prevention at all levels, particularly in enhancing insulin sensitivity, which is most beneficial for primary prevention and early-stage disease management.

There is emerging evidence that exercise can improve metabolic control and may help prevent or delay complications in individuals with type II diabetes, but further trials are necessary to evaluate the long-term efficacy of exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of type II diabetes by physical training. Epidemiological considerations and study methods. King, H., Kriska, AM.[2022]

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