Culturally Adapted Dietary Clinical Trial in PR
Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)
Harvard School of Public Health (HSPH)
250 participants
May 2, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria11
- 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
Interventions
Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05962372