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.

项目概要 PREDIMED 试验提供了强有力的证据，表明坚持地中海饮食 模式与较低的 2 型糖尿病 (T2D) 和心血管疾病 (CVD) 风险相关。然而这样的饮食 不同文化背景的人群可能不熟悉或无法理解。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 代谢组概况、心理社会因素或食物获取情况。我们的总体目标是预防 CVD 和 T2D 美国 (US) 领土波多黎各 (PR) 的高危成年人中，心脏代谢负担 通过促进健康、可及且文化上适当的饮食来避免过度饮食。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臂、平行试验和可行性 随机试验，测试根据文化定制的干预措施与标准健康饮食的效果 改善 44 名 PR 成人心脏代谢危险因素的计划。参与者高度评价 PROMED 文化可接受性、实用性和满意度。对血压和 HDL-C 需求的短期益处 需要经过长期的考验。因此，我们建议通过以下方式测试这些机制和干预措施的功效： 将 PROMED 扩展为一项为期 2 年、2 组、平行随机临床试验，受试者为 250 名自由生活的老年人 PR 30-65 年，至少有一种失调的危险因素，但无 CVD 或 T2D。干预组将 通过每月的个人咨询并辅之以每日的咨询，获得适合文化的份量控制建议 短信，以及每月供应的豆类、植物油以及当地生产的水果和蔬菜。 对照组的参与者将接受标准份量控制的非定制营养咨询 每月的个人会议通过每日短信和每月的超市优惠券得到加强，但没有 食物。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) 风险估计 合并队列方程。我们的目标是确定介导 PROMED 与 PROMED 功效的生物学机制。 通过测量血浆代谢特征来预测 CIS 和 10 年 ASCVD 风险的变化进行控制；评估 CIS 和 ASCVD 心理社会因素（自我效能、自我控制、意图）的变化和调节；和 确定按群体划分的粮食安全、获取和支出的变化，以及对饮食、CIS 和 ASCVD 的影响。作为 作为一个探索性目标，我们将邀请 70 人中的一名家庭成员来评估干预措施的溢出效应 随机参与者进行临床和实验室评估。我们预计 PROMED 将提高参与者的 心脏代谢健康并阐明健康饮食的作用机制。这种新的严格 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。