Lifestyle Intervention for Adults With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in physical activity: accelerometer counts
研究概览
简要总结
Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. The investigators developed a lifestyle intervention based on individual's home activity patterns. The goal of the study is to test the efficacy of this intervention among older adults with diabetes. In addition to physical activity, the investigators will also assess if the intervention will improve social participation.
详细描述
To tailor to the needs of older adults, the investigators developed an innovative lifestyle modification intervention that incorporates rehabilitation approaches to improve the participation of physical activities (PA) among sedentary older adults with type 2 diabetes. The intervention is developed based on well-established health behavior theory (i.e., self-regulation) and the conceptual framework from the World Health Organization, with several innovations not previously investigated in this population. The intervention:
- is tailored based on individual's unique patterns of daily PA performed within his/her environment as opposed to the total amount of PA performed in a day or a recall of activities over some time period;
- uses an accelerometer-assisted, field-based method to address the individual's unique physical and social environment;
- is delivered by a trained occupational therapist in brief counseling sessions, which can be easily translated into real clinical settings; and
- addresses participation, a patient-centered outcome that is associated with quality of life but has received limited attention outside of rehabilitation research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 years or older
- •Has Type 2 diabetes mellitus
- •Sedentary (less than 150 minutes of exercise in week)
- •English-speaking
- •Community living (i.e., not a nursing home resident)
- •Ambulatory with or without cane or walker
- •Able to operate accelerometer
- •Competent to provide informed consent
排除标准
- •Medically unstable
- •Dementia diagnosis
- •Currently taking any medications for memory impairment
- •Currently participating in a physical activity program
- •Heart attack within the past month
- •Self-reported illness or condition that would impair the cooperation with the study team or the ability to complete the study
结局指标
主要结局
Change in physical activity: accelerometer counts
时间窗: baseline, 18 weeks
Change in physical activity from baseline as measured by having participants wearing an accelerometer on their wrists for one week at home at baseline and then at the end of the study.
Change in physical activity: Community Healthy Activities Model Program for Seniors (CHAMPS) survey
时间窗: baseline, 18 weeks
Change in self reported physical activities (Kcal/week) from baseline as measured by participants answering CHAMPS survey questions at baseline and at the end of the study.
次要结局
- Change in social participation:validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) assessment center(baseline, 18 weeks)
研究者
Pearl G Lee, MD
Assistant Professor
University of Michigan