MIND Foods and Aerobic Training in Black Adults with HTN: An ADRD Prevention Pilot RCT (MAT)

摘要 中年非西班牙裔黑人（NHB）成年人的高血压发病率是世界上最高的， 这是ADRD中种族差异的重要来源。2020年9月，两名NIH主任建议 安全网卫生保健提供者和病人和科学家共同设计新的干预措施，以减轻种族和 高血压的社会经济差异。同样在2020年，《柳叶刀》痴呆症预防委员会指出， 生活方式干预可能对高ADRD亚群的ADRD预防特别有效， 心血管疾病风险。这一证据表明，行为干预协同设计的重要性 有高心血管风险的亚群。 因此，我们与安全网初级保健提供者和NHB患者合作，反复共同设计一个 支持高血压自我管理的干预措施和Mediterranean-Dash干预措施 神经退行性延迟（MIND）饮食和有氧训练（MAT）。由于共同设计过程，MAT 解决了患者和安全网提供者的偏好，因此可能是一种吸引人的可持续战略 在一个外部有效的设置，促进心灵饮食和有氧活动，在一个非常高的风险， 亚群MAT也可能是有效的，因为NHB成人中超过50%的CVD归因于 不良的饮食和健康状况，这在很大程度上导致了ADRD的差异。 MAT包括我们的CDC认可的高血压自我管理教育和支持课程， 家庭交付的MIND食品成分和每周两次的MIND烹饪，营养和有氧活动， 视频会议。这种新的干预措施尚未评估其对认知的影响。在早期阶段 随机对照试验，我们的目的是证明可行性和研究MAT对认知的影响。 我们建议在IB阶段试点RCT中测试MAT与我们的注意力控制干预（AC）。我们将 将128名患有高收缩压（≥140 mm Hg）的NHB安全网初级保健患者随机分配至28周 AC或MAT。供应商主导的MAT是28周，其次是24周的自我主导的MAT。测量将处于基线， 治疗后（28周）和随访（52周）。我们将衡量可行性和认知。我们还将 探索干预程序，获取和储存血样，以备将来可能进行的分析。一个成功 试点将支持在安全网初级保健站点进行后续ADRD预防试验，目的是 ADRD预防和减少ADRD差异。

ABSTRACT Hypertension rates among middle-aged non-Hispanic black (NHB) adults are among the highest in the world, which is a significant source of racial disparities in ADRD. In September 2020, two NIH directors recommended safety-net health care providers and patients and scientists co-design novel interventions to alleviate racial and socioeconomic disparities in hypertension. Also in 2020, the Lancet Commission on dementia prevention noted that lifestyle interventions may be particularly efficacious for ADRD prevention in subpopulations with high cardiovascular disease risk. This evidence points to a significant need for behavioral intervention co-design with subpopulations at high cardiovascular risk. Thus, we worked with safety-net primary care providers and NHB patients to iteratively co-design an intervention to support hypertension self-management and Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) diet and aerobic training (MAT). Due to the co-design process, MAT addresses patient and safety-net provider preferences and thus may be an engaging and sustainable strategy in an externally valid setting for the promotion of MIND diet and aerobic activity in a very high-risk subpopulation. MAT is also likely to be potent as over 50% of CVD among NHB adults has been attributed to poor diet and fitness, which contribute greatly to ADRD disparities. MAT involves our CDC-endorsed hypertension self-management education and support classes followed by home-delivered MIND food ingredients and twice-weekly MIND cooking, nutrition, and aerobic activity via videoconference. This novel intervention has not been evaluated for its effects on cognition. In an early stage randomized controlled trial, we aim to demonstrate feasibility and investigate MAT effects on cognition. We propose to test, in a Stage IB pilot RCT, MAT versus our attention control intervention (AC). We will randomize 128 NHB safety-net primary care patients with high systolic blood pressure (≥140 mm Hg) to 28wks of AC or MAT. Provider-led MAT is 28wks followed by 24wks of self-led MAT. Measures will be at baseline, post-treatment (28 weeks), and follow-up (52 weeks). We will measure feasibility and cognition. We will also explore intervention processes and obtain and store blood samples for possible future analyses. A successful pilot would support a follow-on ADRD prevention trial across safety-net primary care sites with the objectives of ADRD prevention and reduction of ADRD disparities.