跳至主要内容
临床试验/NCT05599425
NCT05599425招募中不适用

Development of a Personalized Intervention to Motivate Health Behavior Change in Midlife Adults at Risk for Alzheimer's Disease

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
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

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.

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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