A culturally-tailored dietary trial for cardiometabolic health in Puerto Rico

波多黎各心脏代谢健康的文化定制饮食试验

• 批准号: 10718150
• 负责人: JOSIEMER MATTEI
• 金额: $ 62.35万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-19 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10718150
• 关键词: Address; Adoption; Adult; American; Atherosclerosis; Biological; Blood Pressure; Cardiovascular Diseases; Clinical; Clinical Trials; Consumption; Control Groups; Cooking Utensils; Counseling; Cultural Backgrounds; Data; Diet; Dietary Practices; Dryness; Dyslipidemias; Equation; Expenditure; Fabaceae; Food; Food Access; Goals; Health; Health Food; Healthy Eating; High Density Lipoproteins; Household; Household Products; Hypertension; Individual; Intervention; Laboratories; Maintenance; Measures; Mediating; Mediation; Monitor; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Nutritional Study; Obesity; Olives - dietary; Overweight; Participant; Persons; Plasma; Population; Population Heterogeneity; Prediabetes syndrome; Psychosocial Factor; Puerto Rico; Recommendation; Reporting; Resources; Risk; Risk Estimate; Risk Factors; Risk Reduction; Role; Secure; Self Efficacy; Self-control as a personality trait; Social support; Soybeans; Strategic Planning; Sum; Supermarket; Testing; Text Messaging; Treatment Efficacy; Triglycerides; United States; United States National Institutes of Health; Vegetable Oils; aged; arm; bean; blood lipid; cardiometabolic risk; cardiometabolism; cardiovascular disorder risk; clinically significant; cohort; dietary; dietary guidelines; efficacy testing; experience; food insecurity; food security; fruits and vegetables; glucose metabolism; good diet; group intervention; health disparity; high risk; high risk population; improved; intervention effect; member; metabolome; multidisciplinary; portion control; precision nutrition; predictive signature; prevent; preventive intervention; primary outcome; programs; psychosocial; randomized trial; randomized, clinical trials; response; satisfaction; social; texting support; treatment arm; voucher

Project Summary The PREDIMED trial produced strong evidence showing that adhering to a Mediterranean dietary pattern is associated with lower risk of type 2 diabetes (T2D) and cardiovascular disease (CVD). Yet such a diet may not be familiar or accessible to populations of different cultural backgrounds. Few clinical trials have examined the mechanisms that contribute to cardiometabolic improvements, posited to be through changes in the metabolome profile, psychosocial factors, or access to food. Our overall goal is to prevent CVD and T2D among high-risk adults in the United States (US) territory of Puerto Rico (PR), where cardiometabolic burden is excessive, by promoting a healthy, accessible, and culturally appropriate diet. In response, we led PROMED (Puerto Rico-Optimized Mediterranean-like Diet #NCT03975556), a 4-mo, 2-arm, parallel pilot and feasibility randomized trial that tested the efficacy of a culturally tailored intervention vs. standard healthy eating program in improving cardiometabolic risk factors in 44 adults in PR. Participants highly rated PROMED’s cultural acceptability, practicality, and satisfaction. The short-term benefits on blood pressure and HDL-C need to be tested long-term. We therefore propose to test these mechanisms and the intervention’s efficacy by expanding PROMED to a 2-year, 2-arm, parallel randomized clinical trial among 250 free-living adults aged 30-65y in PR with at least one dysregulated risk factor but free of CVD or T2D. The intervention group will receive culturally tailored portion-control advice through monthly individual counseling reinforced with daily text messages, and a monthly supply of legumes, vegetable oils, and locally produced fruit and vegetables. Participants in the control arm will receive standard portion-control non-tailored nutritional counseling in monthly individual sessions reinforced with daily text messages and monthly supermarket vouchers, but no foods. Primary outcomes are a cardiometabolic improvement score (CIS) denoting improved cumulative risk factors at a clinically significant value and 10-year atherosclerotic CVD (ASCVD) risk estimated from the pooled cohort equation. We aim to determine the biological mechanisms mediating the efficacy of PROMED vs. control by measuring plasma metabolite signatures that predict changes in CIS and 10-year ASCVD risk; assess change and mediation of psychosocial factors (self-efficacy, self-control, intent) on CIS, and ASCVD; and ascertain changes in food security, access, and expenditure by group, and effects on diet, CIS, and ASCVD. As an exploratory aim, we will assess spillover effect of the intervention by inviting one household member of 70 participants at random for clinical and laboratory assessments. We expect PROMED will improve participants’ cardiometabolic health and elucidate posited mechanisms of action of a healthy diet. This new rigorous evidence will enhance dietary guidelines and shift the paradigm from recommending generalized diets to adapting guidance according to the biological, psychosocial, and social needs of diverse populations.

项目摘要 Predimed试验产生了有力的证据，表明坚持地中海饮食 模式与较低的2型糖尿病风险（T2D）和心血管疾病（CVD）有关。然而这样的饮食 可能对不同文化背景的种群不熟悉或无法获得。很少有临床试验有 检查了有助于心脏代谢改进的机制，这表明是通过变化 代谢组的剖面，社会心理因素或获得食物的机会。我们的总体目标是防止CVD和T2D 在美国（美国）的高风险成年人中，波多黎各地区（PR） 通过促进健康，可及且在文化上适当的饮食过度。作为回应，我们领导了 （波多黎各优先化的地中海饮食＃NCT03975556），一个4-MO，2臂，平行的飞行员和可行性 随机试验测试了文化量身定制的干预措施与标准健康饮食的效率 PR中有44名成年人改善心脏代谢危险因素的计划。参与者评为高度评价 文化可接受性，实用性和满意度。血压和HDL-C需要的短期益处 长期测试。因此，我们建议通过 在250名自由生活的成年人中，扩展到2年2年的2年，平行的随机临床试验 30-65y在PR中至少有一个失调的危险因素，但不含CVD或T2D。干预小组将 通过每天加强每日的个人咨询，获得文化量身定制的部分控制建议 短信，每月供应腿部，植物油以及当地生产的水果和蔬菜。 控制臂的参与者将在 每月的每日会议每天都有每日短信和每月超市凭证，但没有 食物。主要结果是表示改善累积风险的心脏代谢改进评分（CIS） 从临床上显着的值和10年动脉粥样硬化CVD（ASCVD）处于临床意义上的因素 汇总队列方程。我们旨在确定介导促进效率的生物学机制。 通过测量预测CI和10年ASCVD风险变化的血浆代谢物特征来控制；评估 在顺式和ASCVD上的社会心理因素（自我效能感，自我控制，意图）的变化和中介；和 确定按小组按粮食安全，获得和支出的变化，以及对饮食，顺式和ASCVD的影响。作为 一个探索目的，我们将通过邀请评估干预效果的一名家庭成员70 参与者随机进行临床和实验室评估。我们希望诺言将改善参与者的 心脏代谢健康和阐明健康饮食作用的后代机制。这个新的严格 证据将增强饮食指南，并将范式从推荐广义饮食转移到 根据不同人群的生物学，社会心理和社会需求来调整指导。