Gray Matters: Multi-domain Lifestyle Behavioral Alzheimer's Disease Prevention Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 主要终点
- Picture Vocabulary
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residing or working in Cache County Utah
- •Possessing smart phone or tablet
排除标准
- •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
结局指标
主要结局
Picture Vocabulary
时间窗: up to 7 months
Picture Vocabulary cognitive test score
Oral Symbol Digit Test
时间窗: up to 7 months
Oral Symbol Digit Test cognitive test score
Montreal Cognitive Assessment
时间窗: up to 7 months
Montreal Cognitive Assessment test score
Rey Auditory Verbal Learning Test
时间窗: up to 7 months
Rey Auditory Verbal Learning Test score
Blood pressure
时间窗: up to 7 months
Systolic and diastolic blood pressure
Flanker Inhibitory Control and Attention Test
时间窗: up to 7 months
Flanker Inhibitory Control and Attention Test cognitive test score
List Sorting Working Memory Test
时间窗: up to 7 months
List Sorting Working Memory Test cognitive test score
Controlled Oral Word Association Test
时间窗: up to 7 months
Controlled Oral Word Association Test score
Body mass index
时间窗: up to 7 months
Height and weight measurement for computing body mass index
LDL Cholesterol
时间窗: up to 7 months
Low-density lipoprotein from venipuncture blood sample
Insulin
时间窗: up to 7 months
insulin from venipuncture blood sample
Skin carotenoid status
时间窗: 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
Triglycerides
时间窗: up to 7 months
triglycerides from venipuncture blood sample
HDL Cholesterol
时间窗: up to 7 months
High-density lipoprotein from venipuncture blood sample
Systemic inflammation
时间窗: up to 7 months
C-reactive protein from venipuncture blood sample
Total cholesterol
时间窗: up to 7 months
Total cholesterol from venipuncture blood sample
次要结局
- Motivation(up to 7 months)
- Depression(up to 7 months)
- Sleep Quality(up to 7 months)
- Physical Activity - Moderate(up to 7 months)
- Physical Activity - Vigorous(up to 7 months)
- Metacognition(up to 7 months)
- Loneliness(up to 7 months)
- Hostility(up to 7 months)
- Stress(up to 7 months)
- Emotional Support(up to 7 months)
- Friendship(up to 7 months)
- Readiness for Change(up to 7 months)
- Nutrition(up to 7 months)
研究者
Maria C Norton, PhD
Professor
Utah State University