Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico (PROSPECT)

July 18, 2023 updated by: Josiemer Mattei, Harvard School of Public Health (HSPH)

Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends

The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00926
        • Recruiting
        • FDI Clinical Research
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jose F Rodriguez-Orengo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Convenience community-wide sample of eligible adults living in all of Puerto Rico.

Description

Inclusion Criteria:

  1. Age 30-75 years old at the time of enrollment
  2. Non-institutionalized
  3. Living in PR at the time of the first interview and the year before and not planning to move from the island within 3 years
  4. Able to answer questions without assistance
  5. Living in a stable dwelling

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with self-reported medically-diagnosed chronic diseases
Time Frame: 4 years
Estimate the prevalence and incidence of chronic diseases (and their dietary and psychosocial risk factors)
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area
Time Frame: 4 years
Estimate differences in prevalence and changes in chronic diseases (and their dietary and psychosocial risk factors) in urban vs. rural area
4 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of clinically-measured metabolic syndrome (e.g. high blood pressure, elevated adiposity, elevated blood glucose, and out-of-normal-range blood lipids), according to dietary and psychosocial risk factors
Time Frame: 4 years
Determine risk of biological metabolic risk factors by changes in psychosocial factors or diet-related factors
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
University of Puerto Rico
University of Massachusetts, Lowell
FDI Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 143792
  • R01HL143792 (U.S. NIH Grant/Contract)
  • R21MD013650 (U.S. NIH Grant/Contract)

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 on the study website.

IPD Sharing Time Frame

2-years

IPD Sharing Access Criteria

The requested data will be shared with investigators via a secured, password-protected software website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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