The design and progress of a multidomain lifestyle intervention to improve brain health in middle-aged persons to reduce later Alzheimer's disease risk: The Gray Matters randomized trial

Abstract Introduction Most Alzheimer's disease (AD) prevention studies focus on older adults or persons with existing cognitive impairment. This study describes the design and progress of a novel pilot intervention, the Gray Matters study. Methods This proof-of-concept randomized controlled trial tests an evidence-based multidomain lifestyle intervention in 146 persons aged 40 to 64 years, in northern Utah. Data collectors were blinded to participants' randomization to treatment (n = 104) or control (n = 42). Intervention targeted physical activity, food choices, social engagement, cognitive simulation, sleep quality, and stress management, and uses a custom smartphone application, activity monitor, and educational materials. Secondary outcomes include biomarkers, body mass index, cognitive testing, and psychological surveys. Results Midway through the study, achievements include a 98.7% retention rate, a 96% rate of compliance with app data entry, and positive trends in behavioral change. Discussion Participants were empowered, learning that lifestyle might impact AD risk, exhibiting positive behavioral changes thus far.