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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
. Having at least one of the following:
. elevated BMI
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
10-year risk score for a first atherosclerotic CVD event (ASCVD score)
. 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
. Not having at least 1 of the five listed metabolic criteria
. Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin) or diabetes-diagnosis values confirmed by laboratory
. Self-reported pregnancy
. Gastrointestinal or chronic condition that would impact eating behaviors or nutritional status