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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
CBTeX Trial 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.Check my eligibility
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.See study design
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.
CBTeX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 17 years old.
Select...
I am female.
CBTeX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin Resistance
Secondary outcome measures
Adiposity
BMI
Cardiorespiratory fitness
+10 moreOther outcome measures
Automatic thoughts
Body image
Mindfulness
+3 moreCBTeX 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
Find a Location
Who is running the clinical trial?
Colorado State UniversityLead Sponsor
125 Previous Clinical Trials
38,059 Total Patients Enrolled
5 Trials studying Insulin Resistance
409 Patients Enrolled for Insulin Resistance
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,941 Total Patients Enrolled
87 Trials studying Insulin Resistance
12,925 Patients Enrolled for Insulin Resistance
University of Colorado, DenverOTHER
1,734 Previous Clinical Trials
2,148,583 Total Patients Enrolled
26 Trials studying Insulin Resistance
1,596 Patients Enrolled for Insulin Resistance
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have major health issues that prevent me from exercising.I am between 12 and 17 years old.I am female.I have a parent, sibling, or grandparent with Type 2 Diabetes.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.I am undergoing psychotherapy, a structured weight loss program, or had bariatric surgery.I use medications that affect my mood, insulin levels, or weight.If your depression score is 21 or higher on the CES-D scale, you may not be able to participate.Your weight is higher than what is considered healthy for your age and sex.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive-Behavioral Therapy Only
- Group 2: Cognitive-Behavioral Therapy followed by Exercise Training
- Group 3: Exercise Training followed by Cognitive-Behavioral Therapy
- Group 4: Exercise Training Only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to register for this research initiative?
"In order to be eligible for this clinical trial, individuals between the ages of 12 and 17 must have a diagnosis of insulin resistance. The study is looking to recruit 300 patients in total."
Answered by AI
Is eligibility for participation in the study restricted to individuals over 30 years old?
"In order to be accepted, participants must meet the age requirement of 12-17 years old. According to records, there are 569 clinical trials currently open for minors and 2428 such studies available for senior citizens."
Answered by AI
Is enrollment in this clinical trial still available?
"Affirmative. The information on clinicaltrials.gov indicates that this research trial, which has been posted since December 1st 2022 is actively seeking volunteers - with a total of 300 individuals needed to be recruited from two medical sites."
Answered by AI
What is the cap for enrollment in this clinical experiment?
"Affirmative. The information accessible on clinicaltrials.gov displays that this experiment is still looking for volunteers, which was initially posted on December 1st 2022 and updated lately the same date. A total of 300 participants are wanted from two different sites."
Answered by AI
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