A Novel Psychological-behavioral Intervention to Promote Physical Activity in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks
研究概览
简要总结
The focus of this study is to test the efficacy of an 8-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks), compared to MI-alone, in a randomized trial of 280 individuals with type 2 diabetes and low baseline physical activity.
详细描述
The investigators are proposing a study that will focus on testing the efficacy of a PP-MI intervention, with additional twice text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks) in individuals with type 2 diabetes. The investigators will enroll 280 type 2 diabetes patients, who will take part in either an 8-week intervention (with 16 weeks of supplemental text messages) or an attention-matched, MI-alone condition.
In this project, the investigators hope to do the following:
- Examine the efficacy of an 8-week, phone-delivered PP-MI intervention for individuals with type 2 diabetes on physical activity-related outcomes, as compared to the MI-alone condition.
- Assess PP-MI's impact on psychological measures (e.g., positive affect [key secondary outcome]), diabetes self-care, function, glycemic control, and cardiometabolic risk, compared to MI alone.
- Examine causal mediation of PP-MI's effects on MVPA at 16 weeks by positive affect (primary hypothesized mediator) and other psychological/cognitive variables across our theoretical model.
Participants will be adult outpatients with type 2 diabetes. They will attend an in-person visit to provide informed consent and complete baseline outcome measures, then will wear an accelerometer to monitor their physical activity for one week to obtain information about baseline activity levels. Upon confirmation of low moderate to vigorous physical activity, participants will be randomized to receive the PP-MI intervention or the MI-alone intervention.
Participants in both groups will be provided a treatment manual, an activity tracker, and other treatment materials. The intervention will be introduced, and the first exercise will be assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 2 Diabetes
- •Low physical activity (<150 minutes/week of moderate to vigorous physical activity)
排除标准
- •Cognitive deficits impeding a participant's ability to provide informed consent or participate
- •Medical conditions likely to lead to death within 6 months.
- •Pre-existing coronary artery disease
- •Moderate-severe depression (Patient Health Questionnaire-9 [PHQ-9] score ≥15)
- •Use of non-basal insulin
- •Inability to participate in physical activity due to another medical condition
- •Inability to receive text messages
- •Inability to read, write, or speak in English
- •Current participation in another intervention or program that has been designed to promote well-being or physical activity
研究组 & 干预措施
Positive Psychology + Motivational Interviewing
Each week, participants in the PP-MI intervention group will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. Each phone session will include PP and goal setting portions. In the PP portion, the study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. In the goal-setting portion, the trainer will (a) review the participant's physical activity goal from the prior week, (b) discuss techniques for improving physical activity (e.g. tracking activity), and (c) help the participant to set a physical activity goal for the next week. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).
干预措施: Positive Psychology + Motivational Interviewing (Behavioral)
Motivational Interviewing
Each week, participants in the MI-alone group will complete an activity related to a health behavior (e.g., thinking about the pros and cons of changing the behavior), then complete a phone session with a study trainer. During the phone session, the trainer will (a) review the prior week's topic, (b) discuss techniques for improving adherence to health behaviors (e.g. tracking activity), and (c) problem-solve barriers and encourage the use of resources. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).
干预措施: Motivational Interviewing (Behavioral)
结局指标
主要结局
Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks
时间窗: Measured for 7 days at baseline and 16 weeks
MVPA will be measured via an accelerometer and recorded in mean minutes/day.
次要结局
- Change from Baseline Overall Activity at 16 weeks(Measured for 7 days at baseline and 16 weeks)
- Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 16 weeks(Baseline, 16 weeks)
研究者
Jeff C. Huffman, MD
Director, Cardiac Psychiatry Research Program
Massachusetts General Hospital