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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

基本信息

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
项目类别：
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

项目摘要

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.

项目总结