Randomized Controlled Trial of a Six-Month Mindfulness-Based Intervention for Type 2 Diabetes

为期 6 个月的基于正念的 2 型糖尿病干预措施的随机对照试验

• 批准号: 9914275
• 负责人: NAZIA T. RAJA-KHAN
• 金额: $ 66.52万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-15 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9914275
• 关键词: Accelerometer; Address; Adult; Adverse effects; Affect; Amputation; Anxiety Disorders; Behavior; Behavioral; Behavioral Sciences; Biometry; Blindness; Blood Glucose; Caring; Cause of Death; Chronic; Chronic Disease; Clinical; Clinical Psychology; Clinical Trials; Complications of Diabetes Mellitus; Control Groups; Development; Diabetes Mellitus; Diet; Dietary intake; Direct Costs; Distress; Endocrinology; Exposure to; Facilities and Administrative Costs; Glucose; Glycosylated hemoglobin A; Guidelines; Health; Health education; High Prevalence; Hour; Hydrocortisone; Inflammation; Informal Social Control; International; Intervention; Kidney Failure; Lead; Link; Longterm Follow-up; Massachusetts; Measures; Mediating; Mental Depression; Meta-Analysis; Mission; Myocardial Infarction; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Overweight; Patients; Physical activity; Physiological; Pilot Projects; Prediabetes syndrome; Prevalence; Procedures; Protocols documentation; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Reporting; Reproducibility; Research; Research Personnel; Resources; Risk; Salivary; Sample Size; Serum; Stress; Stroke; Sympathetic Nervous System; TNF gene; Telephone; Time; United States; Universities; Video Recording; Woman; active control; adverse outcome; alpha-amylase; anxiety symptoms; base; blood glucose regulation; clinically significant; compare effectiveness; comparison intervention; coping; diabetes management; diabetes risk; diabetes self-management; empowered; fasting glucose; follow up assessment; hypothalamic-pituitary-adrenal axis; improved; innovation; medication compliance; mindfulness; mindfulness intervention; mindfulness-based stress reduction; novel; nutrition education; patient population; perceived stress; primary outcome; programs; psychologic; psychosocial; secondary outcome; skills; stress reactivity; stress reduction; systematic review

Project Summary/Abstract Type 2 diabetes (T2DM) is a major public health concern affecting nearly 30 million people in the U.S. and increasing their risk for serious complications including blindness, amputations, kidney failure, heart attacks and strokes. Forty five percent (45%) of people with diabetes report considerable stress related to their diabetes, which is increasingly being recognized as a key factor in worsening glucose control and the progression of T2DM. The proposed project uses mindfulness-based stress reduction (MBSR), a powerful and well researched mindfulness-based intervention, to address stress as a critical barrier to glucose control in patients with T2DM. The objective of this proposal is to conduct a large, fully-powered randomized controlled trial (RCT) to definitively determine the effects of a 6-month MBSR intervention on glucose control in patients with uncontrolled T2DM. We will randomize 290 adults with uncontrolled T2DM to a 6-month MBSR intervention or health education control. The 6-month intervention will consist of the University of Massachusetts standard 8-week MBSR program followed by monthly MBSR booster sessions. Outcomes will be assessed at baseline, 8-weeks, 6 months and 12 months. Specific Aims are: 1) To conduct a RCT to determine the effects of a 6-month MBSR intervention compared to health education on glucose control in 290 patients with uncontrolled T2DM. The primary outcome will be hemoglobin A1c (HbA1c), a measure of average glucose levels over the past 3 months. We hypothesize that between the two groups, there will be a clinically significant 0.5% absolute difference in the mean change in HbA1c from baseline to month 6. Additionally, we will look at fasting glucose and glucose variability as they are also linked with adverse outcomes; 2) To determine the effects of MBSR versus health education control on psychosocial, behavioral and physiological mechanisms potentially mediating its glucose-lowering effects in patients with uncontrolled T2DM. Subjective stress, diabetes-related distress and other psychosocial measures will be assessed. Accelerometry will be used to track physical activity. Unannounced phone calls will be used to obtain 24 hour diet recalls. Physiologic measures include serum hsCRP and TNF-α as markers of chronic inflammation, salivary cortisol to assess the hypothalamic-pituitary-adrenal axis, and salivary α-amylase to assess sympathetic nervous system activity. The proposed study has the potential to transform current standards of care for T2DM by using a novel long- term MBSR intervention as a powerful adjunct intervention for T2DM. MBSR could impact the clinical picture of T2DM by empowering patients with skills for strengthening their own internal resources to promote self- regulation and adaptive coping and reduce stress reactivity, which are all essential for implementing healthy behaviors and are expected to lead to improved glucose control and reduced risk of diabetes complications. This proposal is relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct research on diabetes to improve people's health and quality of life.

项目概要/摘要 2 型糖尿病 (T2DM) 是影响美国近 3000 万人的主要公共卫生问题 增加发生严重并发症的风险，包括失明、截肢、肾衰竭、心脏病 百分之四十五 (45%) 的糖尿病患者报告称其承受了相当大的压力。 糖尿病，越来越多地被认为是血糖控制恶化的关键因素， T2DM 的进展采用基于正念的减压方法（MBSR），这是一种强大且有效的方法。 经过充分研究的基于正念的干预措施，以解决压力作为血糖控制的关键障碍 该提案的目的是进行大规模、全功率的随机对照研究。 试验 (RCT)，以确定 6 个月的 MBSR 干预对患者血糖控制的影响 我们将 290 名患有不受控制的 T2DM 的成年人随机分为 6 个月的 MBSR。 为期 6 个月的干预将由大学组成。 马萨诸塞州标准 8 周 MBSR 计划，随后每月进行 MBSR 加强课程。 在基线、8 周、6 个月和 12 个月时进行评估 具体目标是： 1) 进行随机对照试验： 确定 6 个月的 MBSR 干预与健康教育相比对血糖控制的影响 290 未受控制的 T2DM 患者的主要结果是糖化血红蛋白 (HbA1c)，这是一种平均指标。 我们发现两组之间过去 3 个月的血糖水平存在临床差异。 从基线到第 6 个月，HbA1c 平均变化有 0.5% 的绝对差异。此外，我们 将关注空腹血糖和血糖变异性，因为它们也与不良后果相关 2) 确定 MBSR 与健康教育控制对心理社会、行为和生理的影响 机制可能介导其对未受控制的 T2DM 患者的降血糖作用。 将评估压力、糖尿病相关的痛苦和其他社会心理测量。 用于跟踪身体活动情况的电话将用于获取 24 小时的饮食回忆。 措施包括血清 hsCRP 和 TNF-α 作为慢性炎症的标志物，唾液皮质醇来评估 下丘脑-垂体-肾上腺轴和唾液 α-淀粉酶以评估交感神经系统活动。 拟议的研究有可能通过使用一种新型的长期治疗方法来改变 T2DM 的当前护理标准。 术语 MBSR 干预作为 T2DM 的强大辅助干预措施可能会影响 T2DM 的临床情况。 T2DM 通过赋予患者增强自身内部资源的技能来促进自我 调节和适应性应对并减少压力反应，这些对于实施健康的 行为，预计将改善血糖控制并降低糖尿病并发症的风险。 该提案与国家糖尿病、消化和肾脏研究所的使命相关 疾病（NIDDK）开展糖尿病研究，以改善人们的健康和生活质量。