A novel psychological-behavioral intervention to promote physical activity in type 2 diabetes.

一种促进 2 型糖尿病患者体力活动的新型心理行为干预措施。

• 批准号: 10634682
• 负责人: Jeff C Huffman
• 金额: $ 70.91万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10634682
• 关键词: Accelerometer; Address; Affect; American; Attention; Behavior Therapy; Cardiac; Clinic; Clinical; Cognitive; Complications of Diabetes Mellitus; Counseling; Death Rate; Diabetes Mellitus; Effectiveness; Elements; Exercise; Expectancy; Grant; Health; Intervention; Link; Measures; Mediating; Mediation; Mediator; Mental Depression; Modeling; Motivation; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Outcome Study; Patients; Performance; Personal Satisfaction; Persons; Physical activity; Population; Protocols documentation; Psychological Factors; Psychology; Public Health Practice; Randomized; Randomized, Controlled Trials; Recommendation; Resolution; Risk; Risk Factors; Self Efficacy; Site; Telephone; Testing; Text Messaging; Theoretical model; Time; United States National Institutes of Health; Well in self; Work; behavior change; cardiometabolic risk; cardiovascular risk factor; clinical practice; clinically relevant; comparison intervention; design; diabetes self-management; efficacy evaluation; efficacy trial; exercise intervention; exercise program; glycemic control; gratitude; improved; innovation; internal control; intervention effect; intervention refinement; moderate-to-vigorous physical activity; mortality; motivational enhancement therapy; novel; optimism; pilot trial; primary outcome; process optimization; programs; prospective; psychologic; remote delivery; secondary outcome; sedentary; standard of care; tailored text messaging; telephone session

Among the 30 million Americans with type 2 diabetes (T2D), physical activity is prospectively associated with better glycemic control, reduced cardiovascular risk, and lower rates of death. Unfortunately, more than 75% of T2D patients do not engage in recommended levels of physical activity. Many existing physical activity interventions in T2D have had limited effects on activity and diabetes outcomes, and most do not address psychological factors independently linked with greater activity. Furthermore, physical activity interventions that do appear to be effective are intensive and have been difficult to implement in clinical settings. Innovative, accessible interventions to promote physical activity in T2D are badly needed. Positive psychology (PP) interventions may represent a novel, effective component of a T2D activity intervention. Positive psychological well-being (e.g., optimism, positive affect) is prospectively associated with more physical activity, better glycemic control, and lower cardiac risk. PP interventions use simple exercises (e.g., using personal strengths, accessing gratitude) to systematically cultivate such well-being. In preliminary work, PP has led to substantial increases in activity when combined with existing behavior change programs. Motivational interviewing (MI) could be another element of a scalable activity intervention in T2D. MI is a well-established, effective approach to behavior change that can be delivered remotely. However, MI alone has had somewhat modest effects on activity in T2D, potentially due to low levels of optimism and self-efficacy in this population that could be addressed by PP. Given their complementary approaches to behavior change, PP and MI could be combined to promote optimism, self-efficacy, and motivation to engage in physical activity. We have developed a remotely delivered, combined PP-MI intervention to promote physical activity in T2D patients, and in an NIDDK R21 pilot trial (NIH Stage IB; N=60) we found the intervention to be well- accepted and associated with promising improvements in well-being and physical activity. We now aim to examine the efficacy of the 16-week PP-MI intervention, with 8 weeks of phone sessions and 16 total weeks of text messaging to further support change, in a randomized NIH Stage II efficacy trial in 280 patients with T2D and low baseline physical activity. PP-MI will be compared to a time-matched, MI-alone control condition. The primary study outcome will be improvement in moderate to vigorous physical activity (MVPA) at 16 weeks. We will also measure the intervention’s impact on overall physical activity, psychological measures, diabetes self- care, function, cardiac risk factors, and glycemic control at 8, 16, 24, and 52 weeks. Finally, we will assess PP- MI’s mechanism of effect on MVPA via causal mediation analyses to allow further intervention refinement. Through its potential to promote physical activity in T2D, the remotely delivered PP-MI program could impact public health and clinical practice. If PP-MI shows efficacy in this trial, we will more definitively examine its effects on glycemic control and cardiac risk in a larger, Stage III effectiveness-based trial.

在3000万患有2型糖尿病（T2D）的美国人中， 与更好的血糖控制、降低心血管风险和降低死亡率相关。不幸的是， 超过75%的2型糖尿病患者没有进行推荐水平的体力活动。许多现有 2型糖尿病患者的体力活动干预对活动和糖尿病结局的影响有限， 没有解决与更大活动独立相关的心理因素。此外，体力活动 似乎确实有效的干预措施是密集的，并且难以在临床上实施。 设置.迫切需要创新的、可获得的干预措施来促进T2D患者的身体活动。 积极心理学（PP）干预可能是T2D活动的一种新的有效成分 干预积极的心理健康（例如，乐观，积极的影响）与 更多的体力活动，更好的血糖控制，更低的心脏病风险。PP干预使用简单的练习 (e.g.,利用个人优势，获得感恩），系统地培养这种幸福感。初步 工作，PP已经导致活动的大幅增加时，与现有的行为改变计划相结合。 动机访谈（MI）可能是T2D可扩展活动干预的另一个要素。mi是 一种行之有效的方法来改变行为，可以远程交付。但是，MI单独 对2型糖尿病患者的活动有一定程度的影响，可能是由于乐观和自我效能水平较低 可以通过PP解决的问题。鉴于他们在行为改变方面的互补方法， PP和MI可以结合起来，以促进乐观，自我效能感和动机从事体力活动。 我们已经开发了一种远程交付的PP-MI联合干预，以促进体力活动， 在NIDDK R21试点试验（NIH阶段IB; N = 60）中，我们发现干预效果良好。 接受并与幸福和身体活动的有希望的改善相关联。我们现在的目标是 检查为期16周的PP-MI干预的有效性，其中8周的电话会议和16周的 在280例T2D患者中进行的一项随机NIH II期疗效试验中， 和低基线身体活动。将PP-MI与时间匹配的单独MI对照条件进行比较。的 主要研究结果是在16周时中度至剧烈体力活动（MVPA）的改善。我们 还将测量干预对整体身体活动、心理测量、糖尿病自我 第8、16、24和52周时的护理、功能、心脏风险因素和血糖控制。最后，我们将评估PP- 通过因果中介分析MI对MVPA的影响机制，以进一步完善干预措施。 通过其促进T2D患者身体活动的潜力，远程提供的PP-MI计划可以 影响公共卫生和临床实践。如果PP-MI在本试验中显示有效性，我们将更明确地检查 其对血糖控制和心脏病风险的影响，在一个更大的，III期有效性为基础的试验。