NCT03794531

Brief Summary

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 2,500 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Mar 2019Apr 2029

First Submitted

Initial submission to the registry

December 18, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

10.2 years

First QC Date

December 18, 2018

Last Update Submit

April 30, 2026

Conditions

Keywords

Hispanics/LatinosMinority healthPuerto RicoCardiovascular diseaseCardiometabolic healthChronic disease risk factorsDisaster researchCaribbean and Latin AmericaPopulation healthProspective studyAllostatic loadFood insecurityLongitudinal study

Outcome Measures

Primary Outcomes (1)

  • Number of participants with self-reported medically-diagnosed chronic diseases

    Estimate the prevalence and incidence of chronic diseases (and their dietary and psychosocial risk factors)

    4 years

Secondary Outcomes (1)

  • Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area

    4 years

Other Outcomes (1)

  • 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

    4 years

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 30-75 years old at the time of enrollment
  • Non-institutionalized
  • 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
  • Able to answer questions without assistance
  • Living in a stable dwelling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puerto Rico Consortium for Clinical Investigation

San Juan, 00927, Puerto Rico

RECRUITING

Related Publications (4)

  • Mattei J, Tucker KL, Falcon LM, Rios-Bedoya CF, Kaplan RM, O'Neill HJ, Tamez M, Mendoza S, Diaz-Alvarez CB, Orozco JE, Acosta Perez E, Rodriguez-Orengo JF. Design and Implementation of the Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends (PROSPECT). Am J Epidemiol. 2021 May 4;190(5):707-717. doi: 10.1093/aje/kwaa231.

    PMID: 33083832BACKGROUND
  • Mattei J, Tamez M, O'Neill J, Haneuse S, Mendoza S, Orozco J, Lopez-Cepero A, Rios-Bedoya CF, Falcon LM, Tucker KL, Rodriguez-Orengo JF. Chronic Diseases and Associated Risk Factors Among Adults in Puerto Rico After Hurricane Maria. JAMA Netw Open. 2022 Jan 4;5(1):e2139986. doi: 10.1001/jamanetworkopen.2021.39986.

  • Lopez-Cepero A, O'Neill HJ, Marrero A, Falcon LM, Tamez M, Rodriguez-Orengo JF, Mattei J. Association between adverse experiences during Hurricane Maria and mental and emotional distress among adults in Puerto Rico. Soc Psychiatry Psychiatr Epidemiol. 2022 Dec;57(12):2423-2432. doi: 10.1007/s00127-022-02355-2. Epub 2022 Sep 1.

  • Xu W, Lopez-Cepero A, O'Neill HJ, Plym A, Austin SB, Mattei J. Food Insecurity Is Associated With Dysfunctional Eating Behaviors Among Adults in Puerto Rico. J Nutr Educ Behav. 2023 Sep;55(9):644-650. doi: 10.1016/j.jneb.2023.05.255. Epub 2023 Jul 1.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, saliva, hair.

MeSH Terms

Conditions

Heart DiseasesHypertensionObesityDyslipidemiasMetabolic SyndromeCardiovascular DiseasesChronic DiseaseInflammationStress, PsychologicalDepressionFeeding Behavior

Condition Hierarchy (Ancestors)

Vascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersDisease AttributesPathologic ProcessesBehavioral SymptomsBehaviorBehavior, Animal

Central Study Contacts

Josiemer Mattei, PhD

CONTACT

Martha Tamez, ScD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition

Study Record Dates

First Submitted

December 18, 2018

First Posted

January 7, 2019

Study Start

March 1, 2019

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
2-years
Access Criteria
The requested data will be shared with investigators via a secured, password-protected software website.

Locations