A Psychological-behavioral Intervention to Increase Activity in Type 2 Diabetes: a 16-week Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of PP-MI Sessions Completed by Participants
研究概览
简要总结
The focus of this study is to examine the feasibility, acceptability, and impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention in a group of patients with type 2 diabetes (T2D).
详细描述
The investigators will compare a combined positive psychology and motivational interviewing (PP-MI) intervention that is adapted for patients with T2D to a diabetes education intervention (control) in a randomized controlled trial. The investigators will enroll 70 participants, who will be randomized to either a 16-week PP-MI health behavior intervention or an 16-week diabetes education intervention.
In this project, the investigators plan to do the following:
- Examine the feasibility and acceptability of a 16-week, telephone-delivered health behavior intervention utilizing PP exercises and MI with systematic goal-setting.
- Determine whether the PP-MI intervention leads to greater increases in physical activity than the education intervention in T2D patients.
- Explore the impact of the PP-MI intervention on other psychological, behavioral, and medical outcomes, compared to the education intervention.
Participants will undergo an initial screening visit during which they will meet with study staff in person. At this visit, study eligibility will be confirmed, and eligible and willing participants will be enrolled. Following enrollment, participants will complete self-report measures, and vital signs and A1c will be measured. They then will take home and wear an accelerometer for one week, to measure baseline physical activity.
Baseline information about enrolled participants will be obtained from the participants, care providers, and the electronic medical record as required for characterization of the population. This information will include data regarding medical history (type 2 diabetes mellitus), current medical variables (conditions affecting physical activity), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).
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
- •T2D. Eligible patients will meet American Diabetes Association (ADA) criteria for T2D (e.g., HbA1c [A1C] ≥6.5%, fasting glucose ≥126 mg/d), with diagnosis confirmed by their diabetes clinician and/or medical record review.
- •Low physical activity. Low physical activity will be defined as ≤150 minutes/week of MVPA (corresponding to ADA recommendations for moderate or greater intensity aerobic physical activity). Physical activity will be measured using a brief questionnaire adapted from the International Physical Activity Questionnaire (IPAQ).
排除标准
- •Cognitive impairment precluding consent or meaningful participation.
- •Lack of phone availability.
- •Inability to read/write in English.
- •Additional medical conditions (e.g., severe arthritis) that preclude physical activity.
- •Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac rehabilitation), or other clinical trials.
结局指标
主要结局
Number of PP-MI Sessions Completed by Participants
时间窗: 16 weeks
Measured by number of PP-MI sessions completed by participants in the PP-MI group.
次要结局
- Ease of MI Component(Weeks 1-16)
- Change in Self-Efficacy for Exercise(Change in score from Baseline to 16 weeks, and Baseline to 24 weeks)
- Change in Resilience(Change in score from Baseline to 16 weeks, and Baseline to 24 weeks)
- Utility of PP Component(Weeks 1-16)
- Change in Sedentary Time(Change from Baseline to 16 weeks, and Baseline to 24 weeks)
- Utility of MI Component(Weeks 1-16)
- Ease of PP Component(Weeks 1-16)
- Change in Optimism(Change in score from Baseline to 16 weeks, and Baseline to 24 weeks)
- Change in Anxiety(Change in score from Baseline to 16 weeks, and Baseline to 24 weeks)
- Change in Moderate-Vigorous Physical Activity(Change from Baseline to 16 weeks, and Baseline to 24 weeks)
- Change in Physical Activity(Change from Baseline to 16 weeks, and Baseline to 24 weeks)
- Change in Depression(Change in score from Baseline to 16 weeks, and Baseline to 24 weeks)
- Change in Positive Affect(Change in score from Baseline to 16 weeks, and Baseline to 24 weeks)
- Change in Diabetes Self-Care(Change in score from Baseline to 16 weeks, and Baseline to 24 weeks)
- Change in Perceived Social Support(Change in score from Baseline to 16 weeks, and Baseline to 24 weeks)
研究者
Jeff C. Huffman, MD
Associate Chief of Psychiatry for Clinical Services
Massachusetts General Hospital