Recruiting
Culturally Adapted Dietary Clinical Trial in PR
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.
ClinicalTrials.gov IDNCT05962372
PhaseNA
Enrollment250
SponsorHarvard School of Public Health (HSPH)
Age30 Years
SexALL
Conditions studied
Diabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, High Triglycerides, High Blood Glucose, Abdominal Obesity
About this study
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.
Interventions
- Behavioral: Culturally tailored food and diet advice — Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
- Behavioral: Standard healthy eating advice — 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)
- Cardiometabolic Improvement Score (CIS) (6; 12; 18; 24 months)
Eligibility information
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
Study locations
- Puerto Rico Consortium for Clinical Investigation, San Juan, 00926 Puerto Rico
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.