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

MIND 食品和患有 HTN 的黑人成人的有氧训练：ADRD 预防试点随机对照试验 (MAT)

基本信息

批准号：
10585366
负责人：
DANIEL O CLARK
金额：
$ 68.64万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-03-15 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10585366
关键词：
Address Adult Adverse event Aerobic Exercise Aftercare Age Age Years Alzheimer&apos s disease related dementia Behavior Therapy Biological Markers Black race Blood Blood Pressure Blood specimen Cardiovascular Diseases Caring Cognition Cognitive Dementia Diet Disease Disparity Drops Education Educational Intervention Educational Status Federally Qualified Health Center Food Foundations Future Genetic Glycosylated hemoglobin A Health Personnel Home Hypertension Intervention Measures Mediator Medical Minority Nerve Degeneration Not Hispanic or Latino Outcome Assessment Participant Patients Plasma Prevention Prevention trial Primary Care Process Provider Public Health Race Randomized Randomized, Controlled Trials Recommendation Research Risk Factors Scientist Self Efficacy Self Management Site Social support Socioeconomic Status Source System Testing Training Trust Unhealthy Diet United States National Institutes of Health Work age related attentional control behavior change black patient cardiovascular disorder risk cardiovascular risk factor care seeking cooking dementia risk design diet and fitness fitness follow-up health disparity high risk improved intervention cost intervention effect intervention participants intervention refinement lifestyle intervention low socioeconomic status middle age novel nutrition patient oriented pilot trial preference prevent primary care patient primary care provider racial disparity safety net satisfaction socioeconomic disparity therapy design therapy development treatment as usual treatment effect videoconference

项目摘要

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.

抽象的中年非西班牙裔黑人（NHB）成年人的高血压率是世界上最高的，这是ADRD种族分布的重要来源。 2020年9月，建议两名NIH董事安全网医疗保健提供者，患者和科学家共同设计新颖的干预措施，以减轻种族和高血压中的社会经济差异。同样在2020年，预防柳叶刀委员会提到了这种生活方式的干预措施对于在高群中预防ADRD可能特别有效心血管疾病风险。该证据表明对行为干预共同设计的重要需求具有高心血管风险的亚群。那就是我们与安全网络的初级保健提供者和NHB患者合作，以迭代共同设计干预以支持高血压自我管理和地中海 - 划干的干预措施神经退行性延迟（思维）饮食和有氧训练（MAT）。由于共同设计过程，垫子解决患者和安全网络提供商的偏好，因此可能是一种引人入胜且可持续的策略在外部有效的环境中，可以在非常高风险的情况下促进思维饮食和有氧活动亚种群。 MAT也可能是潜在的饮食和健身差，这对ADRD差异做出了巨大贡献。 MAT涉及我们的疾病预防控制中心的高血压自我管理教育和支持课程，然后由家用的心灵食品成分以及每周两次的思维烹饪，营养和有氧活动视频会议。这种新颖的干预措施尚未评估其对认知的影响。在早期随机对照试验，我们旨在证明可行性并研究MAT对认知的影响。我们将建议在IB阶段PILOT RCT中测试MAT与我们的注意力控制干预措施（AC）。我们将随机分组128 NHB安全网络医疗高收缩压（≥140mm Hg）至28WKS的初级保健患者交流或垫子。提供者为28周提供了24周的垫子。措施将处于基线，治疗后（28周）和随访（52周）。我们将衡量可行性和认知。我们也会探索干预过程并获取并存储血液样本以进行未来的分析。成功飞行员将支持跨安全网络的初级保健站点进行的后续预防试验，其目标预防和减少ADRD差异。