Lauren B Shomaker1, Lauren Gulley2, Allison M Hilkin3, Emma Clark4, Shelly Annameier4, Sangeeta Rao5, Bonny Rockette-Wagner6, Andrea Kriska6, Kenneth P Wright7, Eric Stice8, Kristen J Nadeau3, Megan M Kelsey3. 1. Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, Fort Collins, CO 80523, United States; Department of Pediatrics, Section of Endocrinology, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, United States; Department of Community and Behavioral Health, Colorado School of Public Health, Aurora, CO, United States. Electronic address: lauren.shomaker@colostate.edu. 2. Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, Fort Collins, CO 80523, United States; Department of Pediatrics, Section of Endocrinology, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, United States. 3. Department of Pediatrics, Section of Endocrinology, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, United States. 4. Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, Fort Collins, CO 80523, United States. 5. Department of Clinical Sciences, Colorado State University, Fort Collins, CO, United States. 6. Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States. 7. Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, United States. 8. Oregon Research Institute, Eugene, OR, United States.
Abstract
BACKGROUND: Depressive symptoms often manifest in adolescence and predict worsening insulin sensitivity, a key precursor in the path to β-cell failure and type 2 diabetes (T2D). OBJECTIVE: To assess the efficacy of a six-week cognitive-behavioral group versus six-week health education group for improving insulin sensitivity and preserving β-cell function in adolescent girls at-risk for T2D with depressive symptoms and evaluate mechanisms underlying the association between depression and insulin dynamics. DESIGN: Randomized controlled trial of N = 150 12-17-year-old girls with overweight/obesity (body mass index [BMI; kg/m2] ≥85th percentile), elevated depressive symptoms (Center for Epidemiologic Studies-Depression Scale [CES-D] total score > 20), and diabetes family history. METHODS:Girls at-risk for T2D with elevated depressive symptoms are recruited from the Denver-metropolitan area and randomized to participate in one of two six-week interventions. The cognitive-behavioral group is a depression prevention program involving psycho-education, restructuring negative thoughts, and behavioral activation. The health education group is a didactic control that provides knowledge about healthy living. Participants are assessed at baseline, immediate post-intervention, and one-year follow-up. Primary outcomes are insulin sensitivity and β-cell function from oral glucose tolerance tests. Secondary outcomes are disinhibited eating, physical activity, sleep, and cortisol. SUMMARY: Results from this adequately powered randomized controlled trial will determine whether decreasing depressive symptoms with a behavioral health program preventatively alters insulin sensitivity and β-cell function trajectories in adolescents at-risk for T2D. Results from the MIND Project will add to knowledge of the contribution of depressive symptoms to T2D risk.
RCT Entities:
BACKGROUND:Depressive symptoms often manifest in adolescence and predict worsening insulin sensitivity, a key precursor in the path to β-cell failure and type 2 diabetes (T2D). OBJECTIVE: To assess the efficacy of a six-week cognitive-behavioral group versus six-week health education group for improving insulin sensitivity and preserving β-cell function in adolescent girls at-risk for T2D with depressive symptoms and evaluate mechanisms underlying the association between depression and insulin dynamics. DESIGN: Randomized controlled trial of N = 150 12-17-year-old girls with overweight/obesity (body mass index [BMI; kg/m2] ≥85th percentile), elevated depressive symptoms (Center for Epidemiologic Studies-Depression Scale [CES-D] total score > 20), and diabetes family history. METHODS:Girls at-risk for T2D with elevated depressive symptoms are recruited from the Denver-metropolitan area and randomized to participate in one of two six-week interventions. The cognitive-behavioral group is a depression prevention program involving psycho-education, restructuring negative thoughts, and behavioral activation. The health education group is a didactic control that provides knowledge about healthy living. Participants are assessed at baseline, immediate post-intervention, and one-year follow-up. Primary outcomes are insulin sensitivity and β-cell function from oral glucose tolerance tests. Secondary outcomes are disinhibited eating, physical activity, sleep, and cortisol. SUMMARY: Results from this adequately powered randomized controlled trial will determine whether decreasing depressive symptoms with a behavioral health program preventatively alters insulin sensitivity and β-cell function trajectories in adolescents at-risk for T2D. Results from the MIND Project will add to knowledge of the contribution of depressive symptoms to T2D risk.
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