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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12-17
SponsorColorado State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female

Age 12-17 years

Body Mass Index (BMI)>= 85 for age and sex

Type 2 Diabetes (T2D) first-or second-degree relative

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive-Behavioral Therapy followed by Exercise Training

    Behavioral

    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 Therapy

    Behavioral

    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 Only

    Behavioral

    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 Only

    Behavioral

    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.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Cognitive-Behavioral Therapy followed by Exercise TrainingExperimental treatment 1 intervention
Group B: Exercise Training followed by Cognitive-Behavioral TherapyActive comparator 1 intervention
Group C: Exercise Training OnlyActive comparator 1 intervention
Group D: Cognitive-Behavioral Therapy OnlyActive comparator 1 intervention

Trial outcomes

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

Time frame
1-year

Secondary outcomes

1

Insulin sensitivity

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

Time frame
1-year
2

Cardiorespiratory fitness

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

Time frame
1-year
3

Rate Perceived Exertion

Adolescent report on the Borg Scale during cycle ergometry testing

Time frame
1-year
4

Exercise enjoyment

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

Time frame
1-year

Other outcomes

1

Dispositional mindfulness

Adolescent report on the Mindful Attention Awareness Scale - Adolescent Version (MAAS-A), total score

Time frame
1-year
2

Weight bias internalization

Adolescent report on the Weight Bias Internalization Scale for Youth (WBIS-Y), total score

Time frame
1-year
3

Body image

Multidimensional Body Self-Relations Questionnaire Measure composed of 10 subscales: appearance evaluation, fitness evaluation, fitness orientation, health evaluation, health orientation, illness orientation, body areas satisfaction, overweight preoccupation, and self-classified weight.

Time frame
1-year
4

Automatic thoughts

Adolescent report of frequency of negative and positive thoughts on the Automatic Thoughts Questionnaire (ATQ), negative and positive scale scores

Time frame
1-year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Colorado State University

Lead sponsor

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

Collaborator

University of Colorado, Denver

Collaborator