Culturally Adapted Dietary Clinical Trial in PR (PRECISION)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Obesity; Diabetes Mellitus, Type 2; Dyslipidemias; Abdominal Obesity; High Triglycerides; High Blood Glucose
• Intervention / Treatment: Behavioral: Culturally tailored food and diet advice; Behavioral: Standard healthy eating advice

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 supermarket vouchers 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
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela Ruiz, MS, RDN; Phone Number: 787-309-4207; Email: gruiz@fdipr.com
• Study Contact Backup: Name: Sylvia Lillquist, RDN; Phone Number: 954-243-1174; Email: slillquist@fdipr.com

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00926
    • Recruiting
    • FDI Clinical Research
    • Sub-Investigator: Jose F Rodriguez-Orengo, PhD
    • Contact: Gabriela Ruiz, MS, RDN; Phone Number: 787-309-4207; Email: gruiz@fdipr.com
    • Contact: Sylvia Lillquist, RDN; Phone Number: 954-243-1174; Email: slillquist@fdipr.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 30-65y old at the time of enrollment
2. Non-institutionalized
3. 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
4. Able to answer questions without assistance
5. 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

6. Having at least one of the following:

   1. elevated BMI
   2. elevated waist circumference
   3. self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure at the baseline visit
   4. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the baseline visit
   5. self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia

Exclusion Criteria:

1. Under 30 or over 65 years of age (on the day of the interview).
2. Currently not living in Puerto Rico or not lived on the island for at least 1 year or planning to move within 3 years
3. Institutionalized
4. Not able to answer questions without assistance
5. Not having at least 1 of the five listed metabolic criteria
6. Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin) or diabetes-diagnosis values confirmed by laboratory
7. Self-reported pregnancy
8. Gastrointestinal or chronic condition that would impact eating behaviors or nutritional status
9. Intolerance or allergies to legumes (i.e.: beans and nuts), vegetable oils (i.e.: corn, olive, canola), or fresh produce
10. Living with another person participating in the study
11. Participating in another research study that conflicts with PRECISION

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Culturally tailored food and diet advice; Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
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 supermarket vouchers (no 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.	Behavioral: Standard healthy eating advice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-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%.	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.	6; 12; 18; 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in diet quality score	Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)	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)	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	6; 12; 18; 24 months
Change in levels of waist circumference	Estimate the change in the value of waist circumference (cm)	6; 12; 18; 24 months
Change in levels of BMI	Estimate the change in the value of body mass index (kg/m2)	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)	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)	6; 12; 18; 24 months
Change in food security status	Estimate the change in food security status assessed by the USDA Food Security Module	6; 12; 18; 24 months
Change in self-efficacy score	Estimate the change in self-efficacy score assessed by the Nutritional Self-Efficacy Scale	6; 12; 18; 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in social connectedness score	Estimate the change in social connectedness score from the Social Connectedness Scale/Social Assurance Scale	6; 12; 18; 24 months
Change in social support score	Estimate the change in social support score from the 12-item Social Support Scale	6; 12; 18; 24 months

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Yale University; Broad Institute; FDI Clinical Research
• Investigators: Study Director: Jose F Rodriguez Orengo, PhD, FDI Clinical Research; Principal Investigator: Josiemer Mattei, PhD, MPH, Harvard Chan School of Public Health

Study record dates

Study Major Dates

• Study Start (Estimated): April 16, 2024
• Primary Completion (Estimated): April 16, 2029
• Study Completion (Estimated): April 16, 2029

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Lipid Metabolism Disorders; Hyperlipidemias; Hyperglycemia; Diabetes Mellitus, Type 2; Obesity; Dyslipidemias; Hypertriglyceridemia; Obesity, Abdominal
• Other Study ID Numbers: IRB23-0951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control by contacting study investigators.
• IPD Sharing Time Frame: 10 years
• IPD Sharing Access Criteria: The requested data will be shared with investigators via a secured, password-protected software website, upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No