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试验提供了强有力的证据，表明坚持地中海饮食 2型糖尿病（T2 D）和心血管疾病（CVD）的风险较低。然而这样的饮食 不同文化背景的人群可能不熟悉或无法使用。很少有临床试验 研究了有助于心脏代谢改善的机制，假设是通过改变 代谢组学特征、心理社会因素或食物获取。我们的总体目标是预防CVD和T2 D 在美国（US）领土波多黎各（PR）的高风险成人中， 是过度的，通过促进健康，方便，和文化上适当的饮食。作为回应，我们领导了PROMED （波多黎各优化的Mediterranean样饮食#NCT 03975556），4个月、2组、平行试验和可行性研究 一项随机试验，测试了文化定制干预与标准健康饮食的功效 在改善心脏代谢危险因素的44名成年人在公关计划。参与者高度评价PROMED的 文化的可接受性、实用性和满意度。对血压和HDL-C的短期益处需要 进行长期测试。因此，我们建议测试这些机制和干预的有效性， 将PROMED扩展为一项在250名自由生活的成年人中进行的2年、2组、平行随机临床试验， 30- 65岁PR，至少有一个失调的风险因素，但没有CVD或T2 D。干预组将 通过每月一次的个人咨询，接受文化上量身定制的饮食控制建议， 短信，以及每月供应的豆类，植物油和当地生产的水果和蔬菜。 对照组的参与者将接受标准部分控制的非定制营养咨询， 每月一次的个别会议，每天发短信和每月一次的超市代金券，但没有 食品主要结局是心脏代谢改善评分（CIS），表示累积风险改善 具有临床意义的因素和10年动脉粥样硬化CVD（ASCVD）风险， 合并队列方程。我们的目的是确定介导PROMED与 通过测量预测CIS和10年ASCVD风险变化的血浆代谢物特征进行控制;评估 CIS和ASCVD的心理社会因素（自我效能、自我控制、意图）的变化和介导;以及 确定粮食安全的变化，获得，和支出组，对饮食，CIS和ASCVD的影响。作为 作为一个探索性的目标，我们将邀请一名70岁的家庭成员， 参与者随机进行临床和实验室评估。我们希望PROMED将提高参与者的 心脏代谢健康和阐明健康饮食的假定作用机制。这一新的严格 证据将加强饮食指南，并将范式从推荐一般饮食转变为 根据不同人群的生理、心理和社会需求调整指导。