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。

基本信息

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
项目类别：
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

项目摘要

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，身体活动预计会受到影响不幸的是，与更好的血糖控制、降低心血管风险和降低死亡率有关。超过 75% 的 T2D 患者没有进行许多现有的推荐水平的身体活动。 T2D 体力活动干预对活动和糖尿病结局的影响有限，而且大多数干预措施对 T2D 的影响有限没有解决与更大的活动独立相关的心理因素。看似有效的干预措施是密集的，并且很难在临床中实施迫切需要创新且易于实施的干预措施来促进 T2D 患者的身体活动。积极心理学 (PP) 干预可能是 T2D 活动的一种新颖、有效的组成部分积极的心理健康（例如乐观、积极的情感）与预期相关。通过简单的锻炼进行更多的体力活动、更好的血糖控制和更低的心脏病风险。（例如，利用个人优势、表达感激之情）初步系统地培养这种幸福感。工作中，PP 与现有的行为改变计划相结合，导致活动大幅增加。动机访谈 (MI) 可能是 T2D 的可扩展活动干预的另一个要素。这是一种行之有效的、可以远程实施的行为改变方法。对 T2D 活动的影响不大，可能是由于乐观程度和自我效能感较低鉴于其行为改变的互补方法，可以通过 PP 来解决这一问题， PP 和 MI 可以结合起来，以促进乐观、自我效能和参与体育活动的动力。我们开发了一种远程交付的组合 PP-MI 干预措施，以促进身体活动 T2D 患者，在 NIDDK R21 试点试验（NIH IB 期；N=60）中，我们发现干预效果很好- 我们现在的目标是：检查为期 16 周的 PP-MI 干预的效果，其中包括 8 周的电话会议和总共 16 周的在一项对 280 名 T2D 患者进行的随机 NIH II 期疗效试验中，通过短信进一步支持变革 PP-MI 将与时间匹配的单独 MI 控制条件进行比较。主要研究结果是第 16 周时中度至剧烈体力活动 (MVPA) 的改善。还将衡量干预措施对整体身体活动、心理测量、糖尿病自我评估的影响最后，我们将评估第 8、16、24 和 52 周时的护理、功能、心脏危险因素和血糖控制。 MI 通过因果中介分析对 MVPA 的影响机制，以便进一步细化干预措施。通过其促进 T2D 身体活动的潜力，远程交付的 PP-MI 程序可以如果 PP-MI 在本次试验中显示出疗效，我们将进行更明确的检查。在一项更大规模的基于有效性的 III 期试验中，它对血糖控制和心脏风险的影响。