Culturally Adapted Dietary Clinical Trial in PR

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

Interventions

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.

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.

Sponsors & Collaborators

• FDI Clinical Research

  collaborator OTHER

• Yale University

  collaborator OTHER

• Broad Institute of MIT and Harvard

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  lead OTHER

Principal Investigators

• Josiemer Mattei, PhD, MPH · Harvard Chan School of Public Health

• Jose F Rodriguez Orengo, PhD · FDI Clinical Research

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-02

Primary Completion

2029-05-02

Completion

2029-05-02

Countries

• Puerto Rico

Study Locations