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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
实验性的:Treatment
Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology
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).

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
up to 7 months
Flanker Inhibitory Control and Attention Test
大体时间:up to 7 months
Flanker Inhibitory Control and Attention Test cognitive test score
up to 7 months
List Sorting Working Memory Test
大体时间:up to 7 months
List Sorting Working Memory Test cognitive test score
up to 7 months
Oral Symbol Digit Test
大体时间:up to 7 months
Oral Symbol Digit Test cognitive test score
up to 7 months
Montreal Cognitive Assessment
大体时间:up to 7 months
Montreal Cognitive Assessment test score
up to 7 months
Rey Auditory Verbal Learning Test
大体时间:up to 7 months
Rey Auditory Verbal Learning Test score
up to 7 months
Controlled Oral Word Association Test
大体时间:up to 7 months
Controlled Oral Word Association Test score
up to 7 months
Blood pressure
大体时间:up to 7 months
Systolic and diastolic blood pressure
up to 7 months
Body mass index
大体时间:up to 7 months
Height and weight measurement for computing body mass index
up to 7 months
Insulin
大体时间:up to 7 months
insulin from venipuncture blood sample
up to 7 months
Systemic inflammation
大体时间:up to 7 months
C-reactive protein from venipuncture blood sample
up to 7 months
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
Triglycerides
大体时间:up to 7 months
triglycerides from venipuncture blood sample
up to 7 months
HDL Cholesterol
大体时间:up to 7 months
High-density lipoprotein from venipuncture blood sample
up to 7 months
LDL Cholesterol
大体时间:up to 7 months
Low-density lipoprotein from venipuncture blood sample
up to 7 months
Total cholesterol
大体时间:up to 7 months
Total cholesterol from venipuncture blood sample
up to 7 months

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
up to 7 months
Motivation
大体时间:up to 7 months
Situational Motivation Scale score
up to 7 months
Sleep Quality
大体时间:up to 7 months
Pittsburgh Sleep Quality Index scale score
up to 7 months
Stress
大体时间:up to 7 months
Perceived Stress Scale score
up to 7 months
Emotional Support
大体时间:up to 7 months
Emotional Support subscale from the NIH Toolbox measures for social engagement
up to 7 months
Friendship
大体时间:up to 7 months
Friendship subscale from the NIH Toolbox measures for social engagement
up to 7 months
Hostility
大体时间:up to 7 months
Hostility subscale from the NIH Toolbox measures for social engagement
up to 7 months
Loneliness
大体时间:up to 7 months
Loneliness subscale from the NIH Toolbox measures for social engagement
up to 7 months
Physical Activity - Moderate
大体时间:up to 7 months
self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)
up to 7 months
Physical Activity - Vigorous
大体时间:up to 7 months
self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)
up to 7 months
Nutrition
大体时间:up to 7 months
Diet History Questionnaire
up to 7 months
Readiness for Change
大体时间:up to 7 months
Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale
up to 7 months
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
up to 7 months

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.

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