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试验产生了强有力的证据表明，坚持地中海饮食 这种模式与患2型糖尿病(T2D)和心血管疾病(CVD)的风险较低有关。然而，这样的饮食 不同文化背景的人可能不熟悉或接触不到。很少有临床试验 检查了有助于心脏代谢改善的机制，假设是通过改变 代谢组谱、心理社会因素或获取食物的途径。我们的总体目标是预防心血管疾病和T2D 在美国波多黎各(PR)领土上的高危成年人中，心脏代谢负担 是过度的，通过促进健康、可获得和文化上合适的饮食。作为回应，我们领导了ProMED (波多黎各优化的地中海式饮食#NCT03975556)，4个月、2个臂、平行试验和可行性 一项随机试验，测试文化定制干预与标准健康饮食的效果 改善PR中44名成年人心脏代谢危险因素的计划。参与者对ProMED的评价很高 文化的可接受性、实用性和满足感。对血压和高密度脂蛋白胆固醇需求的短期益处 需要长期测试。因此，我们建议通过以下方式测试这些机制和干预的有效性 将ProMED扩展为一项为期2年的2臂平行随机临床试验，对象为250名生活自理的老年人 30-65岁的PR，至少有一个调节失调的危险因素，但没有CVD或T2D。干预组将 通过每月的个人咨询接受量身定做的量身定做的份量控制建议，并每天 短信，每月供应豆类、植物油和当地生产的水果和蔬菜。 控制组的参与者将接受标准部分控制的非定制营养咨询 每月的个人会议用每天的短信和每月的超市代金券加强，但没有 食物。主要结果是心脏代谢改善评分(CIS)，表示累积风险改善 具有临床显著价值的因素和10年动脉粥样硬化性心血管疾病(ASCVD)风险 集合队列方程。我们的目标是确定调节ProMED疗效的生物学机制。 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 心理社会因素(自我效能感、自我控制力、意向)对CIS和ASCVD的影响及其调节作用 按群体确定食品安全、获取和支出方面的变化，以及对饮食、独联体和ASCVD的影响。AS 作为一个探索性的目标，我们将通过邀请一位70岁的家庭成员来评估干预的溢出效应 随机参加临床和实验室评估。我们预计ProMED将改善参与者的 心脏新陈代谢健康，并阐明健康饮食可能的作用机制。这一新的严谨 证据将加强饮食指南，并将范式从推荐通用饮食转变为 根据不同人群的生物、心理和社会需求调整指导。