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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
250
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.
FDI Clinical Research
San Juan, Puerto Rico
RECRUITING10-year risk score for a first atherosclerotic CVD event (ASCVD score)
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%.
Time frame: 6; 12; 18; 24 months
Cardiometabolic Improvement Score (CIS)
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.
Time frame: 6; 12; 18; 24 months
Changes in diet quality score
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
Time frame: 6; 12; 18; 24 months
Changes in diet satisfaction: diet satisfaction scale
Determine the change in the score of the Diet Satisfaction Questionnaire (DSat-45) (range 45-225; from lowest to highest satisfaction) and its summed seven subscales (ranges 5-40)
Time frame: 6; 12; 18; 24 months
Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)
Determine the change in servings/week of food groups
Time frame: 6; 12; 18; 24 months
Change in levels of waist circumference
Estimate the change in the value of waist circumference (cm)
Time frame: 6; 12; 18; 24 months
Change in levels of BMI
Estimate the change in the value of body mass index (kg/m2)
Time frame: 6; 12; 18; 24 months
Change in levels of blood pressure risk factors
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
Time frame: 6; 12; 18; 24 months
Change in levels of metabolic risk factors
Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL)
Time frame: 6; 12; 18; 24 months
Change in food security status
Estimate the change in food security status assessed by the USDA Food Security Module
Time frame: 6; 12; 18; 24 months
Change in self-efficacy score
Estimate the change in self-efficacy score assessed by the Nutritional Self-Efficacy Scale
Time frame: 6; 12; 18; 24 months
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