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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03794531
Other study ID # 143792
Secondary ID R01HL143792R21MD
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date May 31, 2029

Study information

Verified date May 2024
Source Harvard School of Public Health (HSPH)
Contact Josiemer Mattei, PhD
Phone 6174323017
Email jmattei@hsph.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date May 31, 2029
Est. primary completion date May 31, 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 75 Years
Eligibility 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 Design


Locations

Country Name City State
Puerto Rico FDI Clinical Research San Juan

Sponsors (6)

Lead Sponsor Collaborator
Harvard School of Public Health (HSPH) FDI Clinical Research, National Heart, Lung, and Blood Institute (NHLBI), National Institute on Minority Health and Health Disparities (NIMHD), University of Massachusetts, Lowell, University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

References & Publications (4)

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. 202 — View Citation

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 J — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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 4 years
Primary 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 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 4 years
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