Obesity Clinical Trial
— PROSPECTOfficial 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 2,000 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.
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: |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | FDI Clinical Research | San Juan |
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 |
Puerto Rico,
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
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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