Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 250
- Locations
- 3
- Primary Endpoint
- Cardiometabolic Improvement Score (CIS)
Study Overview
Brief 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.
Detailed Description
This intervention will culturally tailor a diet to the adult population in Puerto Rico based on staple foods as well as culturally appropriate strategies to reduce cardiometabolic risk factors. Based on preliminary results from studies on the island, investigators will conduct a 24-month, 2-arm intervention among 250-350 adults (125-175 per arm) ages 30-65 living in Puerto Rico with at least 1 of 5 cardiometabolic risk factors. The two arms are (1) intervention group with culturally-tailored portion-control Mediterranean Diet-like advice through monthly individual counseling for 12 months, reinforced with daily text messages for 12 months, and a monthly household supply of legumes, vegetable oils, and locally sourced assorted fruit and vegetables for 18 months; (2) control arm with portion-control standard non-tailored nutritional counseling in monthly individual sessions for 12 months, reinforced with daily text messages for 12 months, and monthly assistance to purchase healthy foods for 18 months. From months 18-24, we will monitor behavior maintenance (no food/voucher or counseling), with support from the nutritionist, and cues-to-action texts. Investigators will measure changes in cardiometabolic risk factors and metrics of eating behaviors and psychological factors. The two co-primary outcomes are changes in ASCVD score and cardiometabolic improvement score.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Participants will be unaware of which educational messages are considered intervention or control. Investigators will not be in contact with participants and will only receive coded data. Outcome assessor will be unaware of treatment allocation of participant. Senior investigators, Research Assistants, and laboratory personnel will be blinded to the participants' group allocation.
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Culturally tailored food and diet advice (Behavioral)
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.
Intervention: Standard healthy eating advice (Behavioral)
Outcomes
Primary Outcomes
Cardiometabolic Improvement Score (CIS)
Time Frame: 6; 12; 18; 24 months
Estimate the change in the score; calculated as the added number of risk factors changed over a predefined value; range of 0 to 10; from less to more improvement.
10-year risk score for a first atherosclerotic CVD event (ASCVD score)
Time Frame: 6; 12; 18; 24 months
Estimate the change in first atherosclerotic CVD event (ASCVD) score; the score is calculated using the Pooled Cohort Equation which accounts for biological sex, age, race, total cholesterol, HDL-C, systolic blood pressure, treatment for high blood pressure, current diabetes diagnosis, and smoking status. Scores are expressed as percentage (0-100) with higher scores indicative of higher 10-year risk for ASCVD event. It is categorized as low-risk \<5%; borderline risk 5% to 7.4%; intermediate risk 7.5% to 19.9%; and high risk ≥20%.
Secondary Outcomes
- Change in levels of waist circumference(6; 12; 18; 24 months)
- Change in levels of metabolic risk factors(6; 12; 18; 24 months)
- Change in food security status(6; 12; 18; 24 months)
- Change in self-efficacy score(6; 12; 18; 24 months)
- Changes in diet quality score(6; 12; 18; 24 months)
- Changes in diet satisfaction: diet satisfaction scale(6; 12; 18; 24 months)
- Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)(6; 12; 18; 24 months)
- Change in levels of BMI(6; 12; 18; 24 months)
- Change in levels of blood pressure risk factors(6; 12; 18; 24 months)
Investigators
Josiemer Mattei
Professor of Nutrition
Harvard School of Public Health (HSPH)