About this trial
This project will determine whether a diet culturally adapted to adults in Puerto Rico can effectively decrease cardiometabolic risk factors. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing cardiovascular, type 2 diabetes, and obesity outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 30-65y old at the time of enrollment
Non-institutionalized
Living in PR at the time of recruitment and for at least the previous year and not planning to move from the island within the next 3 years
Able to answer questions without assistance
Disqualifiers
Under 30 or over 65 years of age (on the day of the interview).
Currently not living in Puerto Rico or not lived on the island for at least 1 year or planning to move within 3 years
Institutionalized
Not able to answer questions without assistance
Trial design
Parallel
Treatments tested in this trial
Culturally tailored food and diet advice
BehavioralPuerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
Standard healthy eating advice
BehavioralStandard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate For A Healthy Puerto Rico dietary recommendations.
Treatment groups
Trial outcomes
Primary outcomes
10-year risk score for a first atherosclerotic CVD event (ASCVD score)
Estimate the change in first atherosclerotic CVD event (ASCVD) score; the score is calculated using the Pooled Cohort Equation which accounts for biological sex, age, race, total cholesterol, HDL-C, systolic blood pressure, treatment for high blood pressure, current diabetes diagnosis, and smoking status. Scores are expressed as percentage (0-100) with higher scores indicative of higher 10-year risk for ASCVD event. It is categorized as low-risk \<5%; borderline risk 5% to 7.4%; intermediate risk 7.5% to 19.9%; and high risk ≥20%.
Cardiometabolic Improvement Score (CIS)
Estimate the change in the score; calculated as the added number of risk factors changed over a predefined value; range of 0 to 10; from less to more improvement.
Secondary outcomes
Changes in diet quality score
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
Changes in diet satisfaction: diet satisfaction scale
Determine the change in the score of the Diet Satisfaction Questionnaire (DSat-45) (range 45-225; from lowest to highest satisfaction) and its summed seven subscales (ranges 5-40)
Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)
Determine the change in servings/week of food groups
Change in levels of waist circumference
Estimate the change in the value of waist circumference (cm)
Other outcomes
Change in social connectedness score
Estimate the change in social connectedness score from the Social Connectedness Scale/Social Assurance Scale
Change in social support score
Estimate the change in social support score from the 12-item Social Support Scale
Sponsors and contacts
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Harvard School of Public Health (HSPH)
Lead sponsor
Yale University
Collaborator
Broad Institute of MIT and Harvard
Collaborator
Puerto Rico Consortium for Clinical Investigations
Collaborator