Mobility and Vitality Lifestyle Program-Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Body weight change from Baseline to 4 months
研究概览
简要总结
In prior research the Mobility and Vitality Lifestyle Program for healthy aging and weight management (MOVE UP) was effective in producing a mean loss of >= 5% body weight, with increased physical activity and reduced fatigue. This research will pilot a modified and streamlined version to see if it will be similarly effective for caregivers of family members or friends who have dementia, physical and/or developmental issues, or health problems.
详细描述
The investigators aim to test the feasibility of delivery of a modified and streamlined lifestyle program in volunteer community settings and to provide pilot data to inform the design of future randomized controlled trials that may improve physical and mental health in older adults (50-75) who are providing care for a family member or friend who has dementia, physical and/or developmental issues, or health problems. Current objectives include:
1 . Adapt and pilot the previously studied 32-session, 13-month MOVE UP intervention to a streamlined 12-session (4-month) community-based translational behavioral weight management program. The pilot program will be delivered by a staff interventionist.
- Implement and evaluate the program's impact on weight and healthy lifestyle changes, including physical performance outcomes, at 2 sites, each with at least 6 eligible obese and caregiving adults ages 50-75 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50-75 years of age
- •BMI >=27.0, but <45.0
- •Able to consent for participation and data collection.
- •Medical clearance from physician/health care provider before session 2 in program.
- •Ability to walk with or without assistive device.
- •Acting as a caregiver to someone with dementia, a serious illness, and/or a developmental or physical disability.
排除标准
- •Past MOVE UP participant.
- •If weight loss in the past year is >=10% body weight.
- •Use of wheelchair; participant must be willing and able to increase physical activity.
- •Uncontrolled diabetes mellitus (FBS > 30 & A1C > 11%); to be assessed by physician on medical release.
- •Uncontrolled hypertension (SBP > 180/110) %); to be assessed by physician on medical release.
- •Recent overnight hospitalization (past 6 months).
- •Active treatment for cancer (including melanoma).
- •Significant visual or hearing impairment.
- •Significant cognitive disorder/relevant and significant psychiatric disorder (to be assessed on medical release).
- •Inability to communicate in English/lack of translator.
- •Currently enrolled in another research study that could impact study outcomes or interfere with either study. Exclude if less than 12 months post-graduation from previously enrolled study.
- •Currently enrolled in a weight loss program, such as Weight Watchers.
- •Inability or unwillingness to attend the majority of sessions.
- •In the past year, participating in (other) ways of losing weight, such as bariatric surgery, prescription medications, or non-surgical interventions (reviewed by investigators).
- •Unable to obtain medical clearance by session
- •Not acting as a caregiver.
结局指标
主要结局
Body weight change from Baseline to 4 months
时间窗: 4 months
Number of participants with at least a 5% decrease in body weight from baseline at 4 months
次要结局
- Change in objectively measured physical function from Baseline to 4 months(4 months)
- Changes in caregiver burden(4 months)
- Change in physical function from Baseline to 4 months(4 months)
- Change in psychosocial measures from Baseline to 4 months(4 months)
- Changes in physical, mental, and social health(4 months)
研究者
Steven M. Albert
Professor and Chair
University of Pittsburgh