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CBT + Exercise for Diabetes Prevention in Adolescents (CBTeX Trial)

N/A

Recruiting

Research Sponsored by Colorado State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 12-17 years

Female

Must not have

T2D/ Type 1 Diabetes (T1D) or any major medical condition (e.g. cardiovascular, renal) that would prohibit the ability to participate in exercise training

Regular medication use affecting mood, insulin, or weight, including stimulants, anti-depressants, anti-psychotics, insulin sensitizers, weight loss medications & chronic steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

No Placebo-Only Group

Summary

This trial is researching how to prevent type 2 diabetes in teenage girls using cognitive-behavioral therapy, exercise training, or a combination of the two.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the interventions might include discomfort during exercise and emotional distress during CBT sessions. However, these activities are generally considered safe with proper supervision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 17 years old.

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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I use medications that affect my mood, insulin levels, or weight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insulin Resistance

Secondary study objectives

Adiposity

BMI

Cardiorespiratory fitness

+10 more

Other study objectives

Automatic thoughts

Body image

Mindfulness

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive-Behavioral Therapy followed by Exercise TrainingExperimental Treatment1 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 OnlyActive Control1 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 TherapyActive Control1 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 OnlyActive Control1 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

0 / 4Eligibility criteria met