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

项目摘要/摘要 迫切需要有效的干预措施来帮助成年2型糖尿病患者实现并保持健康的生活方式。越来越多的美国人患有2型糖尿病，比例接近十分之一。[1]糖尿病不加控制会对肾脏、眼睛和神经造成严重损害，并增加心脏病和中风的风险。控制血糖对避免这些并发症至关重要。要实现血糖控制，需要注意多种生活方式，包括健康的饮食和定期的体育活动。[4-7]然而，只有39%的糖尿病成年人进行体育锻炼。[8]传统的(西方)运动(如散步、骑自行车)可以改善成年T2 DM患者的血糖水平。[9，10]长期坚持对于维持健康益处是必不可少的。然而，与健康的同龄人相比，T2 DM患者在维持体力活动方面面临着更大的障碍，这是因为T2 DM患者超重和肥胖的流行，以及糖尿病的共病(例如，血液循环不佳，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上与传统运动相似，但它可以高度适应身体有缺陷的人。[11]此外，作为一种强调放松、冥想和深呼吸的正念练习，瑜伽对缓解压力的效果可能与T2 DM患者特别相关。[12-14]增加正念可以改善包括体育活动在内的自我照顾行为。最近的荟萃分析表明瑜伽对血糖产生有益影响。[15，16]然而，现有的研究质量普遍较低，而且是在非美国人群中进行的。 这一U01应用是我们成功结束针对成人T2 DM患者的瑜伽干预试验(R21AT008830)后的下一个合乎逻辑的步骤。可行性和可接受性通过项目出席率(80%的课程)、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；第4.1.2节)来衡量。瑜伽还改善了糖尿病患者的自我护理、生活质量，并降低了情绪困扰和糖化血红蛋白。[17，18]这项拟议的研究将在这些努力的基础上，从三个不同的状态(RI、MA和AL)随机抽取90名成年T2 DM患者，进行为期12周的(1)瑜伽或(2)标准运动(SE)计划，并在治疗后3个月和6个月进行随访。这项研究的结果将确定我们在多个地点以强大的严密性和保真度提供这些干预措施的能力，并将确定这种干预措施在不同种族和民族人群中的可行性和可接受性。我们还将研究促进长期坚持瑜伽/体力活动的因素(例如，结果预期、在家练习的障碍)。U01的成功结束将加强未来多点RCT的应用，以严格测试瑜伽改善HbA1c和糖尿病管理的效果。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.