Skip to main content
Clinical Trials/NCT05599425
NCT05599425
Recruiting
N/A

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

Rhode Island Hospital1 site in 1 country40 target enrollmentMarch 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Rhode Island Hospital
Enrollment
40
Locations
1
Primary Endpoint
Generalized Self-Efficacy Scale
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
February 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Generalized Self-Efficacy Scale

Time Frame: 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

Time Frame: 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

Time Frame: 12 weeks

self-report measure of knowledge of modifiable Alzheimer's disease risk factors; higher scores are associated with greater dementia awareness

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials