Clinical trial

Culturally Adapted Dietary Clinical Trial in PR

Recruiting now · Not applicable · 1 countries · Registry ID NCT05962372

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionDiabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, High Triglycerides, High Blood Glucose, Abdominal Obesity

Full registry criteria

Inclusion Criteria: 1. Age 30-65y old at the time of enrollment 2. Non-institutionalized 3. 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 4. Able to answer questions without assistance 5. Having a cellphone with the capacity to receive text messages and be willing to receive daily text messages from the study on the designated cellphone number 6. Having at least one of the following: 1. elevated BMI 2. elevated waist circumference 3. self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure at the baseline visit 4. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the baseline visit 5. self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia Exclusion Criteria: 1. Under 30 or over 65 years of age (on the day of the interview). 2. Currently not living in Puerto Rico or not lived on the island for at least 1 year or planning to move within 3 years 3. Institutionalized 4. Not able to answer questions without assistance 5. Not having at least 1 of the five listed metabolic criteria 6. Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin) or diabetes-diagnosis values confirmed by laboratory 7. Self-reported pregnancy 8. Gastrointestinal or chronic condition that would impact eating behaviors or nutritional status 9. Intolerance or allergies to legumes (i.e.: beans and nuts), vegetable oils (i.e.: corn, olive, canola), or fresh produce 10. Living with another person participating in the study 11. Participating in another research study that conflicts with PRECISION

Treatments and study arms

Culturally tailored food and diet advice

Behavioral

Puerto 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

Behavioral

Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate For A Healthy Puerto Rico dietary recommendations.

Primary outcomes

10-year risk score for a first atherosclerotic CVD event (ASCVD score)6; 12; 18; 24 months

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)6; 12; 18; 24 months

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Puerto Rico Consortium for Clinical Investigation🇵🇷 San Juan, Puerto Rico
Natalia Torres, BSContact
Amarilys F Sylva, PhDSub Investigator