Type 2 diabetes (T2D) is a serious chronic disease that affects 28 million Americans and costs $245 billion in annual U.S. healthcare expenditures. Although previously a disease limited to adulthood, of serious concern are studies showing that rates of adolescent-onset T2D are on the rise. Adolescent-onset T2D is associated with greater health comorbidities and shorter life expectancy than adult-onset T2D. T2D is preventable by decreasing insulin resistance, the major physiological precursor to T2D. Unfortunately, standard-of-care behavioral lifestyle interventions to decrease insulin resistance through weight loss demonstrate insufficient effectiveness in adolescents, necessitating alternative approaches targeting novel risk factors. One novel modifiable risk factor is depression symptoms, a prospective risk factor for worsening insulin resistance and the onset of T2D over time, even after accounting for obesity. Depression likely promotes insulin resistance through stress-related behavior (e.g., hedonic eating, physical inactivity) and stress physiology (e.g., cortisol dysregulation, stress reactivity). In theory, mindfulness-based intervention (MBI) may be distinctively suited for adolescents at-risk for T2D through its potential to decrease depression symptoms, improve stress-related behavior and physiology, and thereby, improve insulin resistance and lessen T2D risk. To begin to test this approach, we completed a single-site, pilot randomized controlled trial (R00 HD069516) that established initial feasibility of recruitment, randomization, retention, protocol adherence, and acceptability/credibility of a 6-week group MBI program, Learning to BREATHE, among the target population. Compared to 6-week group cognitive-behavioral therapy (CBT; a standard-of-care depression intervention), MBI produced significantly greater decreases in depression symptoms and insulin resistance at 6-week/post-treatment follow-up and at 1-year follow-up in adolescents at- risk for T2D. Directly building upon our prior work, the proposed U01 study is a multisite, pilot randomized controlled trial implemented at four sites in preparation for a future multisite efficacy trial assessing the effects of 6-week group MBI, relative to another active treatment (CBT) and a didactic, health education control group (HealthEd), on depression and insulin resistance, as well as stress-related behavior and stress physiology.
Specific aims of the current proposal are to: (1) Test multisite fidelity of training and implementation of 6-week group MBI, CBT, and HealthEd, to adolescents at-risk for T2D with depression symptoms; (2) Evaluate multisite feasibility and acceptability of recruitment, retention, and adherence for a protocol involving randomization to 6- week group MBI, CBT, or HealthEd with 6-week/post-treatment follow-up and 1-year follow-up; and (3) Modify intervention training/implementation and protocol procedures in preparation for a future fully-powered multisite randomized controlled efficacy trial. Completion of these aims will prepare us to apply for a UG3/UH3 efficacy trial. Ultimately, this research will inform a complementary and integrative healthcare approach to adolescents at high-risk for T2D.
The proposed research is highly relevant to public health because the identification of feasible, brief, and cost- effective interventions to decrease depression symptoms in adolescents with overweight/obesity offers the prospect of decreasing insulin resistance, and consequently, mitigating the risk of developing type 2 diabetes (T2D). Adolescents from historically disadvantaged racial/ethnic and socioeconomic backgrounds disproportionately face major stressful life events and psychosocial adversity, develop depression, and experience a high prevalence of obesity and earlier-life onset of T2D. By systematically studying the usefulness of a mindfulness-based intervention to decrease depression, and ultimately, to decrease insulin resistance in adolescents at-risk for T2D, the proposed research is highly consistent with NCCIH's mission to apply rigorous scientific methods to the identification of complementary and integrative health interventions and their roles in improving health and healthcare.
