Puerto Rico Consortium for Clinical Investigation
San Juan, 00926, Puerto Rico
Location status: Recruiting
NCT Number: NCT05962372
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.
Interested in participating?
Request Info30 year–65 year
All sexes
Interventional
Not applicable
San Juan, 00926, Puerto Rico
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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%.
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.
Time frame: 6; 12; 18; 24 months
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
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
Determine the change in servings/week of food groups
Time frame: 6; 12; 18; 24 months
Estimate the change in the value of waist circumference (cm)
Time frame: 6; 12; 18; 24 months
Estimate the change in the value of body mass index (kg/m2)
Time frame: 6; 12; 18; 24 months
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
Time frame: 6; 12; 18; 24 months
Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL)
Time frame: 6; 12; 18; 24 months
Estimate the change in food security status assessed by the USDA Food Security Module
Time frame: 6; 12; 18; 24 months
Estimate the change in self-efficacy score assessed by the Nutritional Self-Efficacy Scale
Time frame: 6; 12; 18; 24 months
Estimate the change in social connectedness score from the Social Connectedness Scale/Social Assurance Scale
Time frame: 6; 12; 18; 24 months
Estimate the change in social support score from the 12-item Social Support Scale
Contact information is provided by the study sponsor or research team.
Harvard School of Public Health (HSPH)
Other
Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)
Acronym: PRECISION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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