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Cognitive-behavioral therapy and exercise training in adolescent females with elevated depression symptoms and at-risk for type 2 diabetes: Protocol for a randomized controlled trial.

Ana M. Gutierrez-Colina,Madison Bristol,E. Clark,Natalia Sanchez,Lauren D. Gulley,Elizabeth B. Ruzicka,Elizabeth P. Handing,E. Kinsella,Eve Kutchman,M. Witten,M. Clementi,T. Thompson,L. Pyle,Stephen Aichele,Andrea B. Goldschmidt,B. Belcher,K. Nadeau,M. Kelsey,L. Shomaker

Published 2023 in Contemporary Clinical Trials

ABSTRACT

BACKGROUND Adolescent-onset type 2 diabetes (T2D) is a major public health concern of growing proportions. Prevention, therefore, is critical. Unfortunately, standard-of-care treatment for T2D prevention (e.g., exercise training) show insufficient effectiveness and do not address key modifiable barriers (e.g., depression symptoms) to exercise engagement. Depression symptoms are associated with both poorer physical fitness and greater insulin resistance, the key risk factor in adolescent-onset T2D. Thus, a targeted prevention approach that addresses depression symptoms in combination with exercise training may offer a novel approach to mitigating T2D risk. METHODS This manuscript describes the design and study protocol for a multi-site, four-arm randomized controlled trial comparing the efficacy of group cognitive-behavioral therapy, group exercise training, and their combinations for the targeted prevention of worsening insulin resistance in N = 300 adolescent females at-risk for T2D with BMI ≥85th percentile and elevated depression symptoms. All four intervention arms will run in parallel and meet weekly for 1 h per week for 6-week to 6-week segments (12 weeks total). Outcomes are assessed at baseline, 6-week mid-treatment, 12-week follow-up, and 1-year follow-up. RESULTS The primary outcome is insulin resistance. Key secondary outcomes include insulin sensitivity, cardiorespiratory fitness, physical activity, depression symptoms, and body measurements. CONCLUSION Study findings will guide the ideal sequencing of two brief T2D prevention interventions for ameliorating the course of insulin resistance and lessening T2D risk in vulnerable adolescents. These interventions will likely be cost-effective and scalable for dissemination, having the potential for significant public health impact on communities at risk for T2D.

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