JMIR Publications

ABSTRACT

Background:

Lifestyle behavior change and mindfulness have direct and synergistic effects on cognitive functioning and may prevent Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD). We are iteratively developing and testing My Healthy Brain (MHB), the first mindfulness-based lifestyle group program targeting AD/ADRD risk factors in older adults with subjective cognitive decline (SCD). Our uncontrolled pilot studies (NIH Stage 1a) have shown that MHB is feasible, acceptable, and associated with improvement in lifestyle behavior and cognitive outcomes.

Objective:

We will compare the feasibility of MHB versus a time- and attention-matched education control (Health Enhancement Program, HEP) in 50 older adults (age ≥ 60) with SCD and AD/ADRD risk factors. Here, we report on the randomized controlled trial (RCT) NIH Stage 1b protocol, manualized treatments, and improved procedures to enhance study outcomes. The RCT will evaluate feasibility benchmarks, improvements in cognitive and lifestyle outcomes, and engagement of hypothesized mechanisms.

Methods:

We are recruiting from clinics, flyers, online research platforms, and community partnerships. Interested individuals are screened for eligibility, provide informed consent, and complete baseline measures via Zoom. Participants are randomized to MHB or HEP, both delivered in small virtual groups (5-10 participants) by a clinical psychologist over eight weeks. MHB participants learn behavior modification and mindfulness skills to achieve individualized lifestyle goals. HEP participants receive lifestyle education and group support. Participants wear a Garmin Vívosmart® 5 to monitor activity and log home practice (mindfulness [MHB], journaling [HEP]) via daily surveys. Assessments are repeated at the end of the program and at a 6-month follow-up. Our primary outcomes are a-priori defined benchmarks for feasibility, acceptability, appropriateness, credibility, satisfaction, and fidelity. Secondary outcomes are cognitive function and lifestyle (physical activity, sleep, nutrition, alcohol/tobacco use, mental and social activity) behaviors.

Results:

Recruitment began in January 2024. We have received 225 inquiries, 40 were eligible, and 21 enrolled in a total of 2 group cohorts. All participants have completed baselines (21/21, 100%). All cohort one participants (n = 9) completed MHB or HEP (≥ 6 of 8 sessions) and post-tests (9/9, 100%). Cohort two (n = 12) is ongoing. Adherence rates for the Garmin (87.1%) and daily surveys (86.1%) are high. No participants have dropped out. Enrollment is projected to be completed by December 2024.

Conclusions:

The RCT will inform the development of a larger efficacy RCT (NIH Stage 2) of MHB versus HEP in a more diverse sample of older adults, testing mechanisms of improvements through theoretically-driven mediators and moderators. The integration of mindfulness with lifestyle behavior change in MHB has the potential to be an effective, accessible, and sustainable approach for increasing the uptake of AD/ADRD risk reduction strategies among older adults. Clinical Trial: ClinicalTrials.gov NCT05934136