Establishing Multi-site Feasibility and Fidelityof Yoga to Improve Management of Type-2 Diabetes

项目摘要/总结 迫切需要有效的干预措施来帮助2型糖尿病（T2 DM）成年人实现并保持健康的生活方式。一个显着的和不断增长的比例的美国人，近十分之一，有T2 DM。[1]不受控制的糖尿病会对肾脏、眼睛和神经造成严重损害，并增加患心脏病和中风的风险。[2，3]控制血糖是避免这些并发症的关键。实现血糖控制需要注意多种生活方式行为，包括健康饮食和定期体育活动。[4-7]然而，只有39%的成年糖尿病患者进行身体活动。[8]传统（西方）运动（例如，步行、骑自行车）可改善成人T2 DM患者的血糖水平。[9，10]长期坚持对维持健康益处至关重要。然而，与健康同龄人相比，T2 DM患者在维持体力活动方面面临更大的障碍，这是由于T2 DM患者中超重和肥胖的患病率以及糖尿病的合并症（例如，血液循环不良、足部护理问题），在运动过程中造成更多不适。 瑜伽在改善身体健康的能力方面与传统运动相似，但对那些身体有限制的人来说非常适合。[11]此外，作为一种专注练习，强调放松，冥想和深呼吸，瑜伽对减轻压力的影响可能与T2 DM患者特别相关。[12-14]增加正念会改善自我照顾行为，包括身体活动。最近的荟萃分析表明瑜伽对血糖结果有有益的影响。[15然而，现有的研究通常质量较低，并且是在非美国人群中进行的。 此U 01应用程序是成功完成T2 DM成人试点瑜伽干预（R21 AT 008830）后的下一个逻辑步骤。可行性和可接受性较高，通过项目出席率（>80%的会议）、研究完成率（92%的参与者）和参与者满意度（M=4.6 ±0.57，1-5分量表;第4.1.2节）进行测量。瑜伽还改善了糖尿病自我护理，生活质量，并导致情绪困扰和HbA 1c的减少。[17 18]拟议的研究将建立在这些努力的基础上，将来自三种不同状态（RI、MA和AL）的90名T2 DM成人的多样化样本随机分配到为期12周的（1）瑜伽或（2）标准运动（SE）计划中，并在治疗后3个月和6个月进行随访。本研究的结果将确定我们在多个临床试验机构中以高度严谨和忠实的方式提供这些干预措施的能力，并将确定该干预措施在不同种族和民族人群中的可行性和可接受性。我们还将检查因素（例如，结果期望，家庭练习的障碍），促进长期坚持瑜伽/体育活动。U 01的成功结束将加强未来多中心RCT的应用，以严格测试瑜伽改善HbA 1c和糖尿病管理的功效。如果得到支持，瑜伽可以为未来的糖尿病管理计划提供一种有吸引力的，可持续的身体活动形式。

PROJECT 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.