Depression & Insulin Sensitivity in Adolescents
NCT03263351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147
Last updated 2025-09-23
Summary
There has been a rise in type 2 diabetes (T2D) rates in adolescents, disproportionately in girls from disadvantaged racial/ethnic groups. This group of girls also is at heightened risk for depression, and depression and T2D are linked. Depressive symptoms are a risk factor for worsening of insulin sensitivity, one if the major precursors to T2D. In preliminary studies, the investigators found that a brief cognitive-behavioral therapy group decreased depressive symptoms and prevented worsening of insulin sensitivity in adolescent girls at-risk for T2D with moderate depressive symptoms. The aims of this study are: 1) to assess the efficacy of a cognitive-behavioral therapy depression group vs. a health education control group for improving insulin sensitivity and preserving insulin secretion in racially/ethnically diverse adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up; 2) to evaluate changes in eating, physical activity, and sleep as explanatory and 3) to test changes in cortisol factors as explanatory.
Conditions
- Type2 Diabetes
- Type 2 Diabetes Mellitus
- Insulin Sensitivity
- Insulin Resistance
- Depression
- Adolescent Obesity
Interventions
- BEHAVIORAL
-
Cognitive-behavioral therapy group
Psychoeducation on depression; cognitive restructuring of negative thoughts; engagement in pleasant activities; healthy rewards; stress and coping.
- BEHAVIORAL
-
Health education group
Didactic health knowledge about interpersonal violence; basic nutrition guidance; sun safety; depression and signs of suicide; gang violence; substance use.
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
National Center for Advancing Translational Sciences (NCATS)
collaborator NIH -
Children's Hospital Colorado
collaborator OTHER -
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
Colorado State University
lead OTHER
Principal Investigators
-
Lauren B Shomaker, PhD · Colorado State University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 17 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-01
- Primary Completion
- 2025-03-31
- Completion
- 2025-05-26
Countries
- United States
Study Locations
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