Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
All Genders
Healthy Volunteers
NCT05962372

Culturally Adapted Dietary Clinical Trial in PR

Led by Harvard School of Public Health (HSPH) · Updated on 2025-07-31

250

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

H

Harvard School of Public Health (HSPH)

Lead Sponsor

F

FDI Clinical Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Culturally Adapted Dietary Clinical Trial in PR

Who Can Participate

Age: 30Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 30-65 years at enrollment
  • Not living in an institution
  • Living in Puerto Rico at recruitment and for at least the past year, with no plans to move in the next 3 years
  • Able to answer questions without help
  • Owns a cellphone that can receive daily text messages and agrees to receive them
  • Has at least one of the following: elevated BMI, elevated waist circumference, diagnosed or treated hypertension, diagnosed pre-diabetes, or diagnosed or treated dyslipidemia
Not Eligible

You will not qualify if you...

  • Younger than 30 or older than 65 years at interview
  • Not living in Puerto Rico, lived there less than 1 year, or plans to move within 3 years
  • Living in an institution
  • Unable to answer questions without help
  • Does not have at least one of the five cardiometabolic risk factors
  • Diagnosed with type 1 or type 2 diabetes or using diabetes medications
  • Pregnant
  • Has gastrointestinal or chronic conditions affecting eating or nutrition
  • Allergic or intolerant to legumes, vegetable oils, or fresh produce
  • Lives with another study participant
  • Participating in another conflicting research study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

FDI Clinical Research

San Juan, Puerto Rico, 00926

Actively Recruiting

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Research Team

S

Sylvia Lillquist, MS, RDN, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Culturally Adapted Dietary Clinical Trial in PR | DecenTrialz