Culturally tailored diet intervention for adults in Puerto Rico

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Puerto Rico Consortium for Clinical Investigation
  San Juan, Puerto Rico Recruiting

Study contacts

• Principal investigator: Josiemer Mattei, PhD, MPH — Harvard Chan School of Public Health
• Study coordinator: Natalia Torres, BS
• Email: natalia.torres@prcci.org
• Phone: 787-523-1593

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.