Center for Health Outcomes and Interdisciplinary Research (CHOIR), Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States.
Harvard Medical School, Boston, MA, United States.
JMIR Res Protoc. 2024 Nov 21;13:e64149. doi: 10.2196/64149.
Lifestyle behavior change and mindfulness have direct and synergistic effects on cognitive functioning and may prevent Alzheimer disease and Alzheimer 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. Our pilot studies (National Institutes of Health [NIH] stage 1A) have shown that MHB is feasible, acceptable, and associated with improvement in lifestyle behavior and cognitive outcomes.
We will compare the feasibility of MHB versus an education control (health enhancement program [HEP]) in 50 older adults (aged ≥60 y) with subjective cognitive decline and AD/ADRD risk factors. In an NIH stage 1B randomized controlled trial (RCT), we will evaluate feasibility benchmarks, improvements in cognitive and lifestyle outcomes, and engagement of hypothesized mechanisms.
We are recruiting through clinics, flyers, web-based research platforms, and community partnerships. Participants are randomized to MHB or the HEP, both delivered in telehealth groups over 8 weeks. MHB participants learn behavior modification and mindfulness skills to achieve individualized lifestyle goals. HEP participants receive lifestyle education and group support. Assessments are repeated after the intervention and at a 6-month follow-up. Our primary outcomes are feasibility, acceptability, appropriateness, credibility, satisfaction, and fidelity benchmarks. The secondary outcomes are cognitive function and lifestyle (physical activity, sleep, nutrition, alcohol and tobacco use, and mental and social activity) behaviors. Data analyses will include the proportion of MHB and HEP participants who meet each benchmark (primary outcome) and paired samples 2-tailed t tests, Cohen d effect sizes, and the minimal clinically important difference for each measure (secondary outcomes).
Recruitment began in January 2024. We received 225 inquiries. Of these 225 individuals, 40 (17.8%) were eligible. Of the 40 eligible participants, 21 (52.5%) were enrolled in 2 group cohorts, 17 (42.5%) were on hold for future group cohorts, and 2 (5%) withdrew before enrollment. All participants have completed before the intervention assessments. All cohort 1 participants (9/21, 43%) have completed either MHB or the HEP (≥6 of 8 sessions) and after the intervention assessments. The intervention for cohort 2 (12/21, 57%) is ongoing. Adherence rates for the Garmin Vivosmart 5 (128/147, 87.1% weeks) and daily surveys (105/122, 86.1% weeks) are high. No enrolled participants have dropped out. Enrollment is projected to be completed by December 2024.
The RCT will inform the development of a larger efficacy RCT (NIH stage 2) of MHB versus the 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 and sustainable approach for increasing the uptake of AD/ADRD risk reduction strategies among older adults.
ClinicalTrials.gov NCT05934136; https://www.clinicaltrials.gov/study/NCT05934136.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/64149.
生活方式行为改变和正念具有直接和协同作用，可以改善认知功能，预防阿尔茨海默病和与阿尔茨海默病相关的痴呆症（AD/ADRD）。我们正在迭代开发和测试 My Healthy Brain（MHB），这是第一个针对有主观认知能力下降的老年人的基于正念的生活方式团体项目，旨在针对 AD/ADRD 的风险因素。我们的初步研究（美国国立卫生研究院[NIH]阶段 1A）表明，MHB 是可行的、可接受的，并且与生活方式行为和认知结果的改善相关。
我们将在 50 名有主观认知能力下降和 AD/ADRD 风险因素的老年人（年龄≥60 岁）中比较 MHB 与教育对照（健康增强计划[HEP]）的可行性。在 NIH 阶段 1B 随机对照试验（RCT）中，我们将评估可行性基准、认知和生活方式结果的改善以及假设机制的参与情况。
我们通过诊所、传单、基于网络的研究平台和社区伙伴关系进行招募。参与者被随机分配到 MHB 或 HEP 组，两组均通过远程医疗小组在 8 周内进行。MHB 参与者学习行为改变和正念技能，以实现个性化的生活方式目标。HEP 参与者接受生活方式教育和小组支持。干预后和 6 个月随访时重复评估。我们的主要结果是可行性、可接受性、适当性、可信度、满意度和保真度基准。次要结果是认知功能和生活方式（体育活动、睡眠、营养、酒精和烟草使用以及心理和社会活动）行为。数据分析将包括满足每个基准（主要结果）的 MHB 和 HEP 参与者的比例，以及配对样本 2 尾 t 检验、Cohen d 效应大小以及每个措施的最小临床重要差异（次要结果）。
招募工作于 2024 年 1 月开始。我们收到了 225 个查询。在这 225 个人中，有 40 人（17.8%）符合条件。在 40 名合格的参与者中，21 人（52.5%）入组了 2 个小组队列，17 人（42.5%）等待未来的小组队列，2 人（5%）在入组前退出。所有参与者都完成了干预前的评估。所有队列 1 参与者（9/21，43%）都完成了 MHB 或 HEP（≥8 次中的 6 次）和干预后的评估。队列 2 的干预（12/21，57%）正在进行中。Garmin Vivosmart 5（128/147，87.1%周）和日常调查（105/122，86.1%周）的依从率很高。没有入组的参与者退出。预计到 2024 年 12 月完成招募。
RCT 将为更大规模的 MHB 与 HEP 在更广泛的老年人样本中进行的疗效 RCT（NIH 阶段 2）提供信息，通过理论驱动的中介和调节因素测试改善的机制。MHB 将正念与生活方式行为改变相结合，具有成为提高老年人 AD/ADRD 风险降低策略采用率的有效和可持续方法的潜力。
ClinicalTrials.gov NCT05934136；https://www.clinicaltrials.gov/study/NCT05934136。
国际注册报告标识符（IRRID）：DERR1-10.2196/64149。
