Culturally Adapted Dietary Clinical Trial in PR

NCT05962372 | Recruiting

• 1 other identifier: IRB23-0951
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Obesity; Hypertension; Dyslipidemias; High Triglycerides; High Blood Glucose; Abdominal Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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 waist circumference

  6; 12; 18; 24 months

• Change in levels of BMI

  6; 12; 18; 24 months

Other Outcomes (2)

• Change in social connectedness score

  6; 12; 18; 24 months

• Change in social support score

  6; 12; 18; 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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.

Behavioral: Standard healthy eating advice

Interventions

Culturally tailored food and diet advice BEHAVIORAL

Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.

Intervention

Standard healthy eating advice BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• FDI Clinical Research: collaborator
• Yale University: collaborator
• Broad Institute of MIT and Harvard: collaborator

Study Sites (1)

FDI Clinical Research

San Juan, 00926, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Hypertension; Dyslipidemias; Hypertriglyceridemia; Hyperglycemia; Obesity, Abdominal

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Josiemer Mattei, PhD, MPH

  Harvard Chan School of Public Health

  PRINCIPAL INVESTIGATOR

• Jose F Rodriguez Orengo, PhD

  FDI Clinical Research

  STUDY DIRECTOR

Central Study Contacts

Sylvia Lillquist, MS, RDN, MPH

CONTACT

954-243-1174; sylvia.lillquist@fdipr.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Donald and Sue Pritzker Associate Professor of Nutrition

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 27, 2023
• Study Start: May 2, 2024
• Primary Completion (Estimated): May 2, 2029
• Study Completion (Estimated): May 2, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 10 years
• Access Criteria: The requested data will be shared with investigators via a secured, password-protected software website, upon request.

Locations

PR (1)