Abstract
BACKGROUND: A total of 12 modifiable risk factors account for 40% of dementia cases globally, yet population adherence to health behaviors associated with these factors is low. Midlife is a critical window for dementia prevention, as brain pathology often begins to accumulate years or decades before the onset of symptoms. Although multidomain behavioral interventions have been efficacious in reducing the risk of cognitive decline, adherence is low. Intrapersonal factors, such as health beliefs, are known mediators of the relationship between knowledge and health behavior. OBJECTIVE: In keeping with stage I of the National Institutes of Health (NIH) Stage Model for Behavioral Intervention Development, this study will use mixed methods to (1) develop an enhanced health education intervention, including an explanatory method for communicating information about dementia risk and personal health beliefs, and (2) conduct a pilot randomized controlled trial (n=20 per intervention arm) over 8 weeks to assess the feasibility of delivering the enhanced intervention versus basic health education alone. METHODS: Phase 1 will involve focus groups and individual qualitative interviews. Focus groups will be analyzed using (1) a descriptive framework matrix analysis and (2) interpretive data review by the research team. Individual qualitative interviews will be coded using applied thematic analysis using a phenomenographic approach. Phase 2 will involve a pilot randomized controlled trial. Proximal outcomes (measured at baseline, 4 weeks, and 8 weeks) include the perceived threat of Alzheimer disease, dementia awareness, and self-efficacy. RESULTS: This project was funded in August 2022. Data collection began in 2023 and is projected to be completed in 2025. CONCLUSIONS: Study findings will reveal the feasibility of delivering an 8-week multidomain health education intervention for primary prevention of dementia in midlife and will provide preliminary evidence of mechanisms of change. TRIAL REGISTRATION: ClinicalTrials.gov NCT05599425; https://clinicaltrials.gov/study/NCT05599425. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/60395.