Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Puerto Rico
FDI Clinical Research
RECRUITING
San Juan
Contact Information
Primary
Sylvia Lillquist, MS, RDN, MPH
sylvia.lillquist@fdipr.com
954-243-1174
Time Frame
Start Date: 2024-05-02
Estimated Completion Date: 2029-05-02
Participants
Target number of participants: 250
Treatments
Experimental: Intervention
Intervention group will receive culturally-tailored portion-control Mediterranean-like advice through monthly individual counseling for 6 months, reinforced with daily text messages for 12 months, and a monthly household supply of legumes (i.e., beans and peanuts), vegetable oils (i.e., olive oil + a blend of canola and soybean), and locally sourced assorted fruit and vegetables for 18 months. From months 18 to 24, we will monitor maintenance of behavior (no food or counseling) with support from the nutritionist available.
Active_comparator: Control
Control group will receive portion-control standard non-tailored nutritional counseling in monthly individual sessions for 6 months, reinforced with daily text messages for 12 months, and monthly assistance to purchase healthy foods for 18 months. From months 18 to 24, we will monitor maintenance of behavior (no voucher or counseling), with support from the nutritionist available.
Sponsors
Collaborators: Broad Institute of MIT and Harvard, Yale University, FDI Clinical Research
Leads: Harvard School of Public Health (HSPH)

This content was sourced from clinicaltrials.gov