Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Generalized Self-Efficacy Scale
研究概览
简要总结
Modifying health behaviors like physical activity level, diet, stress, and mental activity level can lower risk for Alzheimer's disease, but many middle-aged and older adults find it difficult to sustain health behavior changes over the long term. This project will develop a new intervention that educates people about Alzheimer's disease risk factors and helps them understand how their personal health beliefs may prevent them from making long-lasting lifestyle changes. The goal is to help people sustain health behavior changes to prevent or delay the onset of Alzheimer's disease and related dementias.
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
- None
入排标准
- 年龄范围
- 45 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 45-69 years
- •normal cognition (Minnesota Cognitive Acuity Scale > 52)
- •English language fluency
- •at least two of the following: i) BMI > 24.9; ii) systolic blood pressure > 125 mmHg; iii) LDL cholesterol > 115 mg/dL; iv) HbA1C > 6.0%; v) at least one APOE ε4 allele; vi) first-degree relative with AD.
排除标准
- •history of serious mental illness (i.e., schizophrenia, bipolar disorder)
- •history of neurologic or neurodevelopmental disorder
- •current alcohol or drug use disorder based on self-report
- •current enrollment in an AD prevention clinical trial.
研究组 & 干预措施
Healthy Living Education
The basic healthy living education intervention is a 24-session program (two sessions/week for 12 weeks) designed to educate participants about major modifiable risk factors for Alzheimer's disease. The first session each week is didactic, intended to increase knowledge about each Alzheimer's disease risk factor. The second session involves repetition and practice of didactic material as well as strategizing cues to action
干预措施: Basic Healthy Living Education (Behavioral)
Enhanced Healthy Living Education
The enhanced healthy living education intervention will include the same didactic content as the basic HLE course for the first session each week. The second session will focus on personal health beliefs and how they affect specific health behaviors. This may include discussing perceived benefits, troubleshooting barriers to action, making specific action plans, and implementing natural reward systems to bolster self-efficacy.
干预措施: Enhanced Healthy Living Education (Behavioral)
结局指标
主要结局
Generalized Self-Efficacy Scale
时间窗: 12 weeks
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Perceived Threat of Alzheimer's Disease Scale
时间窗: 12 weeks (treatment endpoint)
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Dementia Awareness Questionnaire
时间窗: 12 weeks
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Perceived Threat of Alzheimer's Disease Scale
时间窗: baseline
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Perceived Threat of Alzheimer's Disease Scale
时间窗: 4 weeks
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Dementia Awareness Questionnaire
时间窗: baseline
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Perceived Threat of Alzheimer's Disease Scale
时间窗: 8 weeks
7-item Likert-type scale assessing perceived likelihood, concern, and consequences of Alzheimer's disease; higher scores indicate greater perceived threat
Dementia Awareness Questionnaire
时间窗: 4 weeks
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Dementia Awareness Questionnaire
时间窗: 8 weeks
self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness
Generalized Self-Efficacy Scale
时间窗: baseline
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Generalized Self-Efficacy Scale
时间窗: 4 weeks
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
Generalized Self-Efficacy Scale
时间窗: 8 weeks
10-item self-report questionnaire assessing belief in one's own abilities; higher scores indicate greater self-efficacy
次要结局
- Florida Cognitive Activities Scale(12 weeks)
- Mediterranean Diet Assessment Tool(12 weeks)
- CHAMPS Activities Questionnaire for Older Adults(12 weeks)
- Perceived Stress Scale(12 weeks)
- Positive and Negative Affect Schedule(12 weeks)
- Mediterranean Diet Assessment Tool(baseline)
- CHAMPS Activities Questionnaire for Older Adults(baseline)
- Florida Cognitive Activities Scale(baseline)
- Perceived Stress Scale(baseline)
- Perceived Stress Scale(4 weeks)
- Perceived Stress Scale(8 weeks)
- Positive and Negative Affect Schedule(baseline)
- Positive and Negative Affect Schedule(4 weeks)
- Positive and Negative Affect Schedule(8 weeks)