Culturally tailored diet intervention for adults in Puerto Rico
Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)
This study is testing a special diet plan designed for adults in Puerto Rico to see if it can help reduce heart and diabetes risks over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Harvard School of Public Health (HSPH) Academic / other |
| Locations | 1 site (San Juan) |
| Trial ID | NCT05962372 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of a culturally adapted diet intervention designed for adults in Puerto Rico to reduce cardiometabolic risk factors. The study will involve a 24-month, two-arm intervention with 250-350 participants aged 30-65 who have at least one cardiometabolic risk factor. Participants in the intervention group will receive tailored dietary advice, monthly counseling, and a supply of culturally relevant foods, while the control group will receive standard nutritional counseling and supermarket vouchers. The study will measure changes in cardiometabolic risk factors and eating behaviors over the intervention period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 30-65 living in Puerto Rico with at least one cardiometabolic risk factor.
Not a fit: Patients outside the age range of 30-65 or those not residing in Puerto Rico may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to significant reductions in cardiovascular disease, type 2 diabetes, and obesity among the Puerto Rican adult population.
How similar studies have performed: Other studies have shown success with culturally tailored dietary interventions, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Juan
- FDI Clinical Research — San Juan, Puerto Rico (Recruiting)
Study contacts
- Principal investigator: Josiemer Mattei, PhD, MPH — Harvard Chan School of Public Health
- Study coordinator: Sylvia Lillquist, MS, RDN, MPH
- Email: sylvia.lillquist@fdipr.com
- Phone: 954-243-1174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.