RESUMO
Background: Adhering to a Mediterranean Diet (MedDiet) is associated with a healthier cardiometabolic profile. However, there are limited studies on the MedDiet benefits for non-Mediterranean racial/ethnic minorities, for whom this diet may be unfamiliar and inaccessible and who have a high risk of chronic diseases. Objectives: To describe the study design of a pilot trial testing the efficacy of a MedDiet-like tailored to adults in Puerto Rico (PR). Methods: The Puerto Rican Optimized Mediterranean-like Diet (PROMED) was a single-site 4-mo parallel two-arm randomized pilot trial among a projected 50 free-living adults (25-65 y) living in PR with at least two cardiometabolic risk factors (clinicaltrials.gov registration #NCT03975556). The intervention group received 1 individual nutritional counseling session on a portion-control culturally-tailored MedDiet. Daily text messages reinforced the counseling content for 2 mo, and we supplied legumes and vegetable oils. Participants in the control group received cooking utensils and one standard portion-control nutritional counseling session that was reinforced with daily texts for 2 mo. Text messages for each group were repeated for two more months. Outcome measures were assessed at baseline, 2 and 4 m. The primary outcome was a composite cardiometabolic improvement score; secondary outcomes included individual cardiometabolic factors; dietary intake, behaviors, and satisfaction; psychosocial factors; and the gut microbiome. Results: PROMED was designed to be culturally appropriate, acceptable, accessible, and feasible for adults in PR. Strengths of the study include applying deep-structure cultural components, easing structural barriers, and representing a real-life setting. Limitations include difficulty with blinding and with monitoring adherence, and reduced timing and sample size. The COVID-19 pandemic influenced implementation, warranting replication. Conclusions: If PROMED is proven efficacious in improving cardiometabolic health and diet quality, the findings would strengthen the evidence on the healthfulness of a culturally-appropriate MedDiet and support its wider implementation in clinical and population-wide disease-prevention programs.
RESUMO
The Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends (PROSPECT) is a prospective cohort study in Puerto Rico (PR) aiming to identify trends and longitudinal associations in risk factors for cardiovascular disease (CVD). In 2019, PROSPECT investigators started recruiting a sample of 2,000 adults aged 30-75 years in PR using multistage probabilistic sampling of households and community approaches. Culturally sensitive trained research assistants assess participants, at baseline and at 2-year follow-up, in private rooms at a network of partner clinics. The study collects comprehensive data on demographic factors, socioeconomic and environmental factors, medical history, health conditions, lifestyle behaviors, psychosocial status, and biomarkers of CVD and stress. PROSPECT will estimate the prevalence and incidence of psychosocial, lifestyle, and biological CVD risk factors, describe variations in risk factors by urbanicity (urban areas vs. rural areas) and exposure (before and after) to natural disasters, and determine predictors of longitudinal changes in CVD risk factors. The study has 4 coordinated operational strategies: 1) research productivity (including synergy with existing epidemiologic cohorts of Hispanics/Latinos for comparison); 2) research infrastructure (biorepository, ancillary studies, and clinical research network); 3) capacity-building, education, and training; and 4) community outreach, dissemination, and policy. PROSPECT will inform public health priorities to help reduce CVD in PR.
