Clinical trial NCT03794531: Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico
Official title: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: FDI Clinical Research
name: University of Massachusetts, Lowell
name: San Diego State University
name: Albert Einstein College of Medicine
First posted: 2019-01-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience community-wide sample of eligible adults living in all of Puerto Rico.

Brief 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.


Eligibility criteria: 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:

Primary outcomes:
measure: Number of participants with self-reported medically-diagnosed chronic diseases
timeFrame: 4 years
Secondary outcomes:
measure: Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area
timeFrame: 4 years
Other outcomes:
measure: 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
timeFrame: 4 years
Locations:
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
Study officials:
References:
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.
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 Jan 4;5(1):e2139986. doi: 10.1001/jamanetworkopen.2021.39986.
citation: 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.
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.