. 2018 Dec:75:19-28.

doi: 10.1016/j.cct.2018.10.007. Epub 2018 Oct 17.

Design of a randomized controlled trial to decrease depression and improve insulin sensitivity in adolescents: Mood and INsulin sensitivity to prevent Diabetes (MIND)

Affiliations

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.

PMID: 30342256
PMCID: PMC6249074
DOI: 10.1016/j.cct.2018.10.007

Design of a randomized controlled trial to decrease depression and improve insulin sensitivity in adolescents: Mood and INsulin sensitivity to prevent Diabetes (MIND)

Lauren B Shomaker et al. Contemp Clin Trials. 2018 Dec.

. 2018 Dec:75:19-28.

doi: 10.1016/j.cct.2018.10.007. Epub 2018 Oct 17.

Authors

Affiliations

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.

PMID: 30342256
PMCID: PMC6249074
DOI: 10.1016/j.cct.2018.10.007

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.

Keywords: Adolescent; Depression; Insulin resistance; Insulin sensitivity; Type 2 diabetes.

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Design of a randomized controlled trial to decrease depression and improve insulin sensitivity in adolescents: Mood and INsulin sensitivity to prevent Diabetes (MIND)

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Design of a randomized controlled trial to decrease depression and improve insulin sensitivity in adolescents: Mood and INsulin sensitivity to prevent Diabetes (MIND)

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