Sustainability of MOVE UP Lifestyle Intervention (MOVEUP-S)
2021年11月19日 更新者：Steven M. Albert、University of Pittsburgh
Mobility and Vitality Lifestyle Program-Sustainability
In prior research the investigators have shown that 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.
The current study will pilot a modified and streamlined program to see if it will be similarly effective.
研究概览
详细说明
The investigators aim to test feasibility of Community Health Worker 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. The current objective is to:
- 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 trained Community Health Workers (CHWs).
- 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 adults ages 60-75 years old.
研究类型
介入性
注册 (实际的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15261
- University of Pittsburgh Prevention Research Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 60-75 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.
Exclusion Criteria:
- 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 2.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：MOVE UP-Sustainability
12-week lifestyle intervention focusing on diet and activity
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Each of the 12-group-sessions will focus on incremental behavioral strategies for maintaining recommended healthy eating, activity, and weight loss behaviors.
Participants will monitor body weight and weight loss behaviors.
Body weight will be measured at each in-person session and participants will also be encouraged to measure their body weight on their own.
Beginning in Session 3, participants are given a home physical activity goal of 10 minutes/day, 50 minutes/week.
The goal is raised by 5 minutes/day, 25 minutes/week every other session, the final goal being 30 minutes/day, 150 minutes/week.
All subjects will be recommended to engage in an energy restricted dietary intervention that evidence demonstrates has effectively reduced body weight by 5-7% within the initial 4 months of the intervention.
This will include reducing energy intake to 1200 to 1800 kcal/d based on initial body weight (<200 pounds = 1200 kcal/d; 200 to 250 pounds = 1500 kcal/d; >250 pounds = 1800 kcal/d).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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体重从基线到 4 个月的变化
大体时间：4个月
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4 个月时体重较基线至少下降 5% 的参与者人数
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4个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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客观测量的身体机能从基线到 4 个月的变化
大体时间：4个月
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使用 SPPB 观察性能测量。
分数范围从 0（最差表现）到 12（最佳表现）
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4个月
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从基线到 4 个月的社会心理测量变化
大体时间：4个月
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使用 CES-D 进行自我报告。
分数范围为 0-60，其中分数越高表示抑郁症状越严重。
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4个月
|
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Change in objectively measured physical function from Baseline to 4 months
大体时间：4 months
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Self-reports using CHAMPS.
Score range is 0- 793, with higher scores indicating greater physical activity.
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4 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年6月19日
初级完成 (实际的)
2019年10月30日
研究完成 (实际的)
2019年12月30日
研究注册日期
首次提交
2019年5月21日
首先提交符合 QC 标准的
2019年5月24日
首次发布 (实际的)
2019年5月28日
研究记录更新
最后更新发布 (实际的)
2021年12月2日
上次提交的符合 QC 标准的更新
2021年11月19日
最后验证
2021年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Study19010159
- U48DP005001 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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