Hispanic Community Health Study / Study of Latinos (HCHS/SOL)

Hispanic Community Health Study / Study of Latinos (HCHS/SOL)

The Hispanic Community Health Study / Study of Latinos (HCHS/SOL) is a multi-center epidemiologic study in Hispanic/Latino populations to determine the role of acculturation in the prevalence and development of disease, and to identify risk factors playing a protective or harmful role in Hispanics/Latinos.

Study Overview

Status

Active, not recruiting

Detailed Description

Study goals include studying the prevalence and development of disease in Hispanics/Latinos, the role of acculturation, and to identify risk factors that play protective or harmful roles in Hispanics/Latinos. The target population of 16,000 persons of Hispanic/Latino origin, specifically Cuban, Puerto Rican, Mexican, and Central/South American, to be recruited through four Field Centers affiliated with San Diego State University, Northwestern University in Chicago, Albert Einstein College of Medicine in the Bronx area of New York, and the University of Miami. Seven additional academic centers serve as scientific and logistical support centers.

Study participants aged 18-74 years underwent an extensive clinic exam and assessments to determine baseline risk factors. Annual follow-up interviews will be conducted for 2-4 years to determine health outcomes of interest. Study results will be disseminated through scientific journals and also conveyed to the communities involved in the study in order to improve public health at the local level. Annual follow-up interviews will be conducted for 2-4 years to determine health outcomes of interest. Study results will be disseminated through scientific journals and also conveyed to the communities involved in the study in order to improve public health at the local level.

Study Type

Observational

Enrollment (Actual)

16400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The of over 16,400 persons of Hispanic/Latino origin, specifically Cuban, Puerto Rican, Mexican, and Central/South American, to be recruited through four Field Centers affiliated with San Diego State University, Northwestern University in Chicago, Albert Einstein College of Medicine in the Bronx area of New York, and the University of Miami.

Description

Inclusion Criteria:

• Hispanic/Latino persons living in the US, aged 18-74 in four communities: San Diego, Bronx NY, Chicago, and Miami.Examination of the cohort following a standardized protocol

Exclusion Criteria:

  • Plans to move from the region within 6 months.
  • Unable to complete the study questionnaires in English or Spanish.
  • Women who are pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hispanic/Latinos residing in the US
The cohort consists of over 16,400 persons of Hispanic/Latino origin, ages 18-74, specifically Cuban, Puerto Rican, Mexican, and Central/South American, to be recruited through four Field Centers affiliated with San Diego State University, Northwestern University in Chicago, Albert Einstein College of Medicine in the Bronx area of New York, and the University of Miami.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of cardiovascular and pulmonary disease risk factors in Hispanics/Latinos
Time Frame: Visit 2 data collection through 2019, preliminary and final analyses through 2019, Annual Follow-up through 2019

This is a population-based cohort study of 16,400 Hispanic/Latinos. Objectives:

  • Examination of the cohort following a standardized protocol
  • Follow-up of the cohort to assess vital status, changes in health status, medication intake, and new cardiovascular and pulmonary events (fatal and non-fatal MI, heart failure, stroke, asthma, and COPD.
  • Understand the relationship between changes in risk factors and protective factors and onset of CV and pulmonary disease progression
  • Understand the relationship between changes in sociocultural factors and changes in health
  • Understand the relationship between baseline CV risk profile of women of childbearing age and incidence of select pregnancy complications
Visit 2 data collection through 2019, preliminary and final analyses through 2019, Annual Follow-up through 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Scott Solomon, MD, Brigham and Women's Hospital
  • Principal Investigator: Jianwen Cai, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Robert Kaplan, PhD, Einstein College of Medicine
  • Principal Investigator: Neil Schneiderman, PhD, University of Miami
  • Principal Investigator: Gregory Talavera, MD, MPH, San Diego State University
  • Principal Investigator: Martha Daviglus, MD, PhD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 31, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimated)

February 12, 2014

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCHS-SOL
  • HHSN268201300001I (Other Grant/Funding Number: NHLBI)
  • HHSN268201300002I (Other Grant/Funding Number: NHLBI)
  • HHSN268201300003I (Other Grant/Funding Number: NHLBI)
  • HHSN268201300004I (Other Grant/Funding Number: NHLBI)
  • HHSN268201300005I (Other Grant/Funding Number: NHLBI)
  • HHSN268201300024C (Other Grant/Funding Number: NHLBI)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: HCHS-SOL
    Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
  2. Study Forms
  3. Manual of Procedures

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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