Heart DiseasesPROSPECTNCT03794531
Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico
An observational study of Heart Diseases and Type2 Diabetes, run by Harvard School of Public Health (HSPH) at 1 site in Puerto Rico.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases, Type2 Diabetes, Hypertension
- How many people
- 2,500 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 1 Mar 2019to 30 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Convenience community-wide sample of eligible adults living in all of Puerto Rico.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Puerto Rico1 site, 1 recruiting
- Recruiting
Puerto Rico Consortium for Clinical Investigation
San Juan, 00927
Jonathan Orozco, MS, (787) 930-3257, jonathan.orozco@prcci.org
Naomi Martinez, BSS, (787) 930-3257, nmartinezortiz@hsph.harvard.edu
About this study
Official title: 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 2,500 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.
- Conditions
- Heart Diseases, Type2 Diabetes, Hypertension, Obesity, Dyslipidemias, Metabolic Syndrome
- 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
- Medical subject headings
- Heart Diseases, Hypertension, Obesity, Dyslipidemias, Metabolic Syndrome, Cardiovascular Diseases, Chronic Disease, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start1 Mar 2019
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Josiemer Mattei, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794531
- Sponsor's protocol ID
- 143792
- Other IDs
- R01HL143792, R21MD013650
- Acronym
- PROSPECT
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 33083832Mattei 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 35019984Lopez-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 36048184Xu 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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends
- ClinicalTrials.gov ID
- NCT03794531
- Acronym / sponsor ID
- PROSPECT / 143792
- Conditions
- Heart Diseases, Type2 Diabetes, Hypertension, Obesity, Dyslipidemias, Metabolic Syndrome
- Keywords
- Hispanics/Latinos, Minority health, Puerto Rico, Cardiovascular disease, Cardiometabolic health, Chronic disease risk factors, Disaster research, Caribbean and Latin America
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- 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
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience community-wide sample of eligible adults living in all of Puerto Rico.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 33083832Mattei 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.
- Results publication: PubMed 35019984Mattei 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.
- Results publication: PubMed 36048184Lopez-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.
- Results publication: PubMed 37395692Xu 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.
- Study websiteLink provided by the sponsor.
- Facebook pageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Type2 Diabetes, run by Harvard School of Public Health (HSPH) at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josiemer Mattei, PhD (6174323017, jmattei@hsph.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with self-reported medically-diagnosed chronic diseases (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03794531, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.