Establishing multi-site feasibility and fidelityof yoga to improve management of type-2 diabetes

This $742,805 cooperative agreement from the National Center for Complementary and Integrative Health, a part of the National Institutes of Health, supports research under the Research and Training in Complementary and Integrative Health program. The Miriam Hospital will establish the multi-site feasibility and fidelity of yoga to improve management of type 2 diabetes. Over three years, the awardee will randomize 90 adults with type 2 diabetes from Rhode Island, Massachusetts, and Alabama to a 12-week yoga or standard exercise program with follow-ups at 3 and 6 months post-treatment. The study aims to determine the ability to deliver interventions across multiple sites with strong rigor and fidelity, as well as the feasibility and acceptability of yoga across racially and ethnically diverse populations. Researchers will also examine factors promoting long-term adherence to yoga or physical activity. Successful completion will support future applications to rigorously test the efficacy of yoga for improving HbA1c and diabetes management through a multi-site randomized controlled trial.

Abstract

/summary effective interventions are urgently needed to help adults with type 2 diabetes (T2DM) achieve and maintain a healthy lifestyle. A significant and growing proportion of americans, nearly 1 in 10, have T2DM.[1] uncontrolled diabetes causes serious damage to kidneys, eyes and nerves, and increases risk of heart disease and stroke.[2,3] controlling blood glucose is crucial to avoid these complications. Achieving glycemic control requires attention to multiple lifestyle behaviors including healthy eating and regular physical activity.[4-7] however, only 39% of adults with diabetes are physically active.[8] traditional (western) exercise (e.g., walking, cycling) improves blood glucose levels in adults with T2DM.[9,10] long-term adherence is essential to maintain health benefits. However, individuals with T2DM face greater barriers to sustaining physical activity compared to their healthy peers due to the prevalence of overweight and obesity among those with T2DM and the CO- morbidities of diabetes (e.g., poor circulation, foot care issues) that create more discomfort during exercise. Yoga is similar to traditional exercise in its ability to improve physical fitness but can be highly accommodating to those with physical limitations.[11] moreover, as a mindfulness practice, with emphasis on relaxation, meditation, and deep breathing, yoga's effects on stress reduction may have special relevance to people with T2DM.[12-14] increased mindfulness leads to improved self-care behaviors including physical activity. Recent meta-analyses suggest a beneficial effect of yoga on glycemic outcomes.[15,16] however, existing studies have generally been of low quality and conducted with non-US populations. This U01 application is the next logical step following successful conclusion of our pilot yoga intervention for adults with T2DM (R21AT008830). Feasibility and acceptability were high as measured by program attendance (>80% of sessions), study completion (92% of participants) and participant satisfaction (m=4.6 ±0.57, 1-5 scale; section 4.1.2). Yoga also improved diabetes self-care, quality of life and led to reductions in emotional distress and HBA1C.[17,18] the proposed study will build on these efforts by randomizing a diverse sample of 90 adults with T2DM from three different states (RI, MA, and AL) to a 12-week program of either (1) yoga or (2) standard exercise (SE) with follow up at 3 and 6-months post-treatment. Results of this study will determine our ability to deliver these interventions with strong rigor and fidelity across multiple sites and will establish the feasibility and acceptability of this intervention across racially and ethnically diverse populations. We will also examine factors (e.g., outcome expectations, barriers to home practice) that promote long-term adherence to yoga/physical activity. Successful conclusion of this U01 will strengthen future applications for a multi-site RCT to rigorously test the efficacy of yoga for improving HBA1C and diabetes management. If supported, yoga could offer an attractive, sustainable form of physical activity for future diabetes management programs.