Recruiting

NCT Number: NCT03794531

Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

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.

Recruiting

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Key information

Conditions

Heart Diseases Behavior Behavior, Animal Behavioral Symptoms Body Weight Cardiovascular Diseases Chronic Disease Coping Behavior Depression Depressive Symptoms Diet Habit Disease Attributes Dyslipidemias Feeding Behavior Food Insecurity Glucose Metabolism Disorders Hyperinsulinism Hypertension Inflammation Insulin Resistance Lifestyle Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Physiological Stress Psychological Stress Signs and Symptoms Stress, Psychological Type2 Diabetes Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Puerto Rico Consortium for Clinical Investigation

San Juan, 00927, Puerto Rico

Location status: Recruiting

Location contact

Amarilys Silva, PhD

PRINCIPAL_INVESTIGATOR

Jonathan Orozco, MS

CONTACT

[email protected]

(787) 930-3257

Jose F Rodriguez-Orengo, PhD

SUB_INVESTIGATOR

Naomi Martinez, BSS

CONTACT

[email protected]

(787) 930-3257

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary outcomes

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)

Secondary outcomes

Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area

Time frame: 4 years

Estimate differences in prevalence and changes in chronic diseases (and their dietary and psychosocial risk factors) in urban vs. rural area

Other outcomes

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

Time frame: 4 years

Determine risk of biological metabolic risk factors by changes in psychosocial factors or diet-related factors

Study contacts

Contact information is provided by the study sponsor or research team.

Josiemer Mattei, PhD

CONTACT

[email protected]

6174323017

Martha Tamez, ScD

CONTACT

[email protected]

6174323017

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

Albert Einstein College of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Minority Health and Health Disparities (NIMHD)
Puerto Rico Consortium for Clinical Investigations
San Diego State University
University of Massachusetts, Lowell

Registry information

Official study title

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

Acronym: PROSPECT

Important dates

Study start: 2019
Primary completion: 2029
Study completion: 2029
First posted: Jan 7, 2019
Registry last updated: May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed