Culturally Adapted Dietary Clinical Trial in PR
Recruiting · NCT05962372 · Interventional (participants receive a specific treatment) · Lead sponsor: Harvard School of Public Health (HSPH)
View the official record on ClinicalTrials.gov →Interventions studied
Culturally tailored food and diet adviceStandard healthy eating advice
What this trial 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.
Who can take part
Age range
30 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- elevated waist circumference
- self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure at the baseline visit
- self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the baseline visit
- self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia
Exclusion criteria
- 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
- Intolerance or allergies to legumes (i.e.: beans and nuts), vegetable oils (i.e.: corn, olive, canola), or fresh produce
- Living with another person participating in the study
- Participating in another research study that conflicts with PRECISION
Where it is running
3 locations listed.
- Puerto Rico Consortium for Clinical Investigation - San Juan, Puerto Rico
- Puerto Rico Consortium for Clinical Investigation - San Juan, Puerto Rico
- Puerto Rico Consortium for Clinical Investigation - San Juan, Puerto Rico