Gray Matters Alzheimer's Disease Prevention Intervention
2015年12月2日 更新者:Maria C Norton, PhD、Utah State University
Gray Matters: Multi-domain Lifestyle Behavioral Alzheimer's Disease Prevention Randomized Controlled Trial
This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years.
研究概览
详细说明
This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years.
Participants are randomized to treatment or control condition.
The intervention, spanning a six month period, is an evidence-based health education program.
研究类型
介入性
注册 (实际的)
146
阶段
- 不适用
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
40年 至 64年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age
- Residing or working in Cache County Utah
- Possessing smart phone or tablet
Exclusion Criteria:
- Dementia
- Pregnancy
- Untreated chronic major depression or other psychiatric condition
- Body mass index > 41
- Heart or stroke in prior 6 weeks
- Active cancer treatment
- Unwillingness to seek medical help when serious condition identified at intake
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:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:控制
无干预
|
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实验性的:Treatment
Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology
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The intervention is a health education program including: informational website, experiential classes, custom smart phone or smart table application, wearable activity monitor, and informal coaching by student researchers to provide moral support for lifestyle behavioral change goals.
Participants are not placed on any specific behavioral regimen but instead are encouraged to adopt healthier lifestyle behaviors per the evidence-based health education program, and to attend the experiential classes "cafeteria style" (i.e. based on their individual preferences).
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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 |
|---|---|---|
|
Picture Vocabulary
大体时间:up to 7 months
|
Picture Vocabulary cognitive test score
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up to 7 months
|
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Flanker Inhibitory Control and Attention Test
大体时间:up to 7 months
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Flanker Inhibitory Control and Attention Test cognitive test score
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up to 7 months
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List Sorting Working Memory Test
大体时间:up to 7 months
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List Sorting Working Memory Test cognitive test score
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up to 7 months
|
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Oral Symbol Digit Test
大体时间:up to 7 months
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Oral Symbol Digit Test cognitive test score
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up to 7 months
|
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Montreal Cognitive Assessment
大体时间:up to 7 months
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Montreal Cognitive Assessment test score
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up to 7 months
|
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Rey Auditory Verbal Learning Test
大体时间:up to 7 months
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Rey Auditory Verbal Learning Test score
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up to 7 months
|
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Controlled Oral Word Association Test
大体时间:up to 7 months
|
Controlled Oral Word Association Test score
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up to 7 months
|
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Blood pressure
大体时间:up to 7 months
|
Systolic and diastolic blood pressure
|
up to 7 months
|
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Body mass index
大体时间:up to 7 months
|
Height and weight measurement for computing body mass index
|
up to 7 months
|
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Insulin
大体时间:up to 7 months
|
insulin from venipuncture blood sample
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up to 7 months
|
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Systemic inflammation
大体时间:up to 7 months
|
C-reactive protein from venipuncture blood sample
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up to 7 months
|
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Skin carotenoid status
大体时间:up to 7 months
|
Biophotonic device that shines a light-emitting diode (LED) light at a site on the palm, to measure the skin carotenoid level in units of Raman counts
|
up to 7 months
|
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Triglycerides
大体时间:up to 7 months
|
triglycerides from venipuncture blood sample
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up to 7 months
|
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HDL Cholesterol
大体时间:up to 7 months
|
High-density lipoprotein from venipuncture blood sample
|
up to 7 months
|
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LDL Cholesterol
大体时间:up to 7 months
|
Low-density lipoprotein from venipuncture blood sample
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up to 7 months
|
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Total cholesterol
大体时间:up to 7 months
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Total cholesterol from venipuncture blood sample
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up to 7 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Depression
大体时间:up to 7 months
|
Center for Epidemiologic Studies - Depression scale score
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up to 7 months
|
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Motivation
大体时间:up to 7 months
|
Situational Motivation Scale score
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up to 7 months
|
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Sleep Quality
大体时间:up to 7 months
|
Pittsburgh Sleep Quality Index scale score
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up to 7 months
|
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Stress
大体时间:up to 7 months
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Perceived Stress Scale score
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up to 7 months
|
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Emotional Support
大体时间:up to 7 months
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Emotional Support subscale from the NIH Toolbox measures for social engagement
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up to 7 months
|
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Friendship
大体时间:up to 7 months
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Friendship subscale from the NIH Toolbox measures for social engagement
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up to 7 months
|
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Hostility
大体时间:up to 7 months
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Hostility subscale from the NIH Toolbox measures for social engagement
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up to 7 months
|
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Loneliness
大体时间:up to 7 months
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Loneliness subscale from the NIH Toolbox measures for social engagement
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up to 7 months
|
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Physical Activity - Moderate
大体时间:up to 7 months
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self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)
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up to 7 months
|
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Physical Activity - Vigorous
大体时间:up to 7 months
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self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)
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up to 7 months
|
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Nutrition
大体时间:up to 7 months
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Diet History Questionnaire
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up to 7 months
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Readiness for Change
大体时间:up to 7 months
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Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale
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up to 7 months
|
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Metacognition
大体时间:up to 7 months
|
Total score from a set of seven items (1=much worse to 5=much better), comparing current memory to how it was three years ago, adapted from a questionnaire of functional ability
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up to 7 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。
调查人员
- 首席研究员:Maria C Norton, PhD、Utah State University
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
2014年4月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2014年11月6日
首先提交符合 QC 标准的
2014年11月10日
首次发布 (估计)
2014年11月14日
研究记录更新
最后更新发布 (估计)
2015年12月3日
上次提交的符合 QC 标准的更新
2015年12月2日
最后验证
2015年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.