Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

Obesity Clinical Trial

— PROSPECT  

Official title:

Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03794531
• Other study ID #: 143792
• Secondary ID: R01HL143792R21MD
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: Josiemer Mattei, PhD
• Phone: 6174323017
• Email: jmattei[@]hsph.harvard.edu
• Is FDA regulated: No
• 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: March 31, 2024
• Est. primary completion date: March 31, 2024
• 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:

Related Conditions & MeSH terms

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

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 Jun 30:S1499-4046(23)00391-3. doi: 10.1016/j.jneb.2023.05.255. Online ahe — 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

External Links

•   Facebook page
•   Study website