Menu
Recruiting NCT03794531

Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

— Observational Heart Diseases Type2 Diabetes Hypertension Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Diseases, Type2 Diabetes, Hypertension, Obesity. Basic parameters: 30 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Number of participants with self-reported medically-diagnosed chronic diseases [Time frame: 4 years]
Secondary outcome measures (1)
  • Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area [Time frame: 4 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Puerto Rico · 1 center
  • Puerto Rico Consortium for Clinical Investigation — San Juan

Publications

  • 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 33083832
  • 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. PMID 35019984
  • 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. PMID 36048184
  • 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. PMID 37395692

Identifiers

NCT: NCT03794531 · 143792 · R01HL143792 · R21MD013650

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗