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RecruitingNCT03794531PROSPECTUpdated May 5, 2026

Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

An observational study in Heart Diseases, Type2 Diabetes and Hypertension, sponsored by Harvard School of Public Health (HSPH). Recruiting at 1 site in Puerto Rico. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Harvard School of Public Health (HSPH) · Observational

From the registry’s dates

  • Started Mar 2019; still recruiting 7 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Diseases
  • Type2 Diabetes
  • Hypertension
  • Obesity
  • Dyslipidemias
  • Metabolic Syndrome
  • Cardiovascular Diseases
  • Chronic Disease
  • Inflammation
  • Psychological Stress
  • Physiological Stress
  • Depressive Symptoms
  • Coping Behavior
  • Diet Habit
  • Lifestyle
  • Food Insecurity

Keywords

  • Hispanics/Latinos
  • Minority health
  • Puerto Rico
  • Cardiovascular disease
  • Cardiometabolic health
  • Chronic disease risk factors
  • Disaster research
  • Caribbean and Latin America
  • Population health
  • Prospective study
  • Allostatic load
  • Food insecurity
  • Longitudinal study
03

In context

Heart Diseases

2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 350 across 592 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.

Browse Harvard School of Public Health (HSPH) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

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)

    Time frame: 4 years

Secondary outcomes

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

    Estimate differences in prevalence and changes in chronic diseases (and their dietary and psychosocial risk factors) in urban vs. rural area

    Time frame: 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

    Determine risk of biological metabolic risk factors by changes in psychosocial factors or diet-related factors

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 37395692 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: 2-years

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2019 (actual). Primary completion is estimated for Apr 2029, 121 months after the start.

Of 184 non-industry observational studies under Heart Diseases, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 118. This study's planned 121 months is above that.

Counting every sponsor, half of 238 studies reached it within 45 months; a quarter within 18 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2018
First posted
Jan 7, 2019
StartActual
Mar 1, 2019
Primary completionEst.
Apr 30, 2029
CompletionEst.
Apr 30, 2029
Last update
May 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03794531
Lead 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 Massachusetts, Lowell, San Diego State University, Albert Einstein College of Medicine, Puerto Rico Consortium for Clinical Investigations
Responsible party
Josiemer Mattei (Professor of Nutrition, Harvard School of Public Health (HSPH)) — Principal investigator
First posted
Jan 7, 2019
Start date
Mar 1, 2019
Primary completion
Apr 30, 2029 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
May 5, 2026

Study contacts

Josiemer Mattei, PhD
Contact
jmattei@hsph.harvard.edu
6174323017
Martha Tamez, ScD
Contact
m.tamez@mail.harvard.edu
6174323017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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