NCT02060344

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,400

participants targeted

Target at P75+ for all trials

Timeline
78mo left

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2006Nov 2032

Study Start

First participant enrolled

January 1, 2006

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
18.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2032

Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

26.9 years

First QC Date

January 31, 2014

Last Update Submit

June 18, 2025

Conditions

Cardiovascular Disease

Keywords

Cardiovascular DiseaseHispanicLatinos

Outcome Measures

Primary Outcomes (1)

  • Prevalence of cardiovascular and pulmonary disease risk factors in Hispanics/Latinos

    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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (15)

  • Sorlie PD, Aviles-Santa LM, Wassertheil-Smoller S, Kaplan RC, Daviglus ML, Giachello AL, Schneiderman N, Raij L, Talavera G, Allison M, Lavange L, Chambless LE, Heiss G. Design and implementation of the Hispanic Community Health Study/Study of Latinos. Ann Epidemiol. 2010 Aug;20(8):629-41. doi: 10.1016/j.annepidem.2010.03.015.

    PMID: 20609343BACKGROUND

  • Isasi CR, Gallo LC, Cai J, Gellman MD, Xie W, Heiss G, Kaplan RC, Talavera GA, Daviglus ML, Pirzada A, Wassertheil-Smoller S, Llabre MM, Youngblood ME, Schneiderman N, Perez-Stable EJ, Napoles AM, Perreira KM. Economic and Psychosocial Impact of COVID-19 in the Hispanic Community Health Study/Study of Latinos. Health Equity. 2023 Mar 27;7(1):206-215. doi: 10.1089/heq.2022.0211. eCollection 2023.

    PMID: 37007686DERIVED

  • Alvarez CS, Aviles-Santa ML, Freedman ND, Perreira KM, Garcia-Bedoya O, Kaplan RC, Daviglus ML, Graubard BI, Talavera GA, Thyagarajan B, Camargo MC. Associations of Helicobacter pylori and hepatitis A seropositivity with asthma in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL): addressing the hygiene hypothesis. Allergy Asthma Clin Immunol. 2021 Nov 24;17(1):120. doi: 10.1186/s13223-021-00625-3.

    PMID: 34819160DERIVED

  • Maldonado LE, Adair LS, Sotres-Alvarez D, Mattei J, Mossavar-Rahmani Y, Perreira KM, Daviglus ML, Van Horn LV, Gallo LC, Isasi CR, Albrecht SS. Dietary Patterns and Years Living in the United States by Hispanic/Latino Heritage in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). J Nutr. 2021 Sep 4;151(9):2749-2759. doi: 10.1093/jn/nxab165.

    PMID: 34320207DERIVED

  • Bai F, Chen J, Pandey D, Durazo-Arvizu R, Talavera GA, Allison MA, Perreira KM, Schneiderman N, Sutherland MW, Cai J, Daviglus ML, Testai FD. Stroke Risk Factor Status and Use of Stroke Prevention Medications Among Hispanic/Latino Adults in HCHS/SOL. Stroke. 2021 Apr;52(4):1339-1346. doi: 10.1161/STROKEAHA.120.031216. Epub 2021 Mar 4.

    PMID: 33657859DERIVED

  • Chen GC, Qi Q, Hua S, Moon JY, Spartano NL, Vasan RS, Sotres-Alvarez D, Castaneda SF, Evenson KR, Perreira KM, Gallo LC, Pirzada A, Diaz KM, Daviglus ML, Gellman MD, Kaplan RC, Xue X, Mossavar-Rahmani Y. Accelerometer-assessed physical activity and incident diabetes in a population covering the adult life span: the Hispanic Community Health Study/Study of Latinos. Am J Clin Nutr. 2020 Nov 11;112(5):1318-1327. doi: 10.1093/ajcn/nqaa232.

    PMID: 32910816DERIVED

  • Chen GC, Chai JC, Yu B, Michelotti GA, Grove ML, Fretts AM, Daviglus ML, Garcia-Bedoya OL, Thyagarajan B, Schneiderman N, Cai J, Kaplan RC, Boerwinkle E, Qi Q. Serum sphingolipids and incident diabetes in a US population with high diabetes burden: the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). Am J Clin Nutr. 2020 Jul 1;112(1):57-65. doi: 10.1093/ajcn/nqaa114.

    PMID: 32469399DERIVED

  • Elfassy T, Mossavar-Rahmani Y, Van Horn L, Gellman M, Sotres-Alvarez D, Schneiderman N, Daviglus M, Beasley JM, Llabre MM, Shaw PA, Prado G, Florez H, Zeki Al Hazzouri A. Associations of Sodium and Potassium with Obesity Measures Among Diverse US Hispanic/Latino Adults: Results from the Hispanic Community Health Study/Study of Latinos. Obesity (Silver Spring). 2018 Feb;26(2):442-450. doi: 10.1002/oby.22089. Epub 2018 Jan 10.

    PMID: 29318759DERIVED

  • Corsino L, Sotres-Alvarez D, Butera NM, Siega-Riz AM, Palacios C, Perez CM, Albrecht SS, Espinoza Giacinto RA, Perera MJ, Horn LV, Aviles-Santa ML. Association of the DASH dietary pattern with insulin resistance and diabetes in US Hispanic/Latino adults: results from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). BMJ Open Diabetes Res Care. 2017 Jul 7;5(1):e000402. doi: 10.1136/bmjdrc-2017-000402. eCollection 2017.

    PMID: 28761660DERIVED

  • Mattei J, Sotres-Alvarez D, Daviglus ML, Gallo LC, Gellman M, Hu FB, Tucker KL, Willett WC, Siega-Riz AM, Van Horn L, Kaplan RC. Diet Quality and Its Association with Cardiometabolic Risk Factors Vary by Hispanic and Latino Ethnic Background in the Hispanic Community Health Study/Study of Latinos. J Nutr. 2016 Oct;146(10):2035-2044. doi: 10.3945/jn.116.231209. Epub 2016 Sep 7.

    PMID: 27605403DERIVED

  • Wong WW, Strizich G, Heo M, Heymsfield SB, Himes JH, Rock CL, Gellman MD, Siega-Riz AM, Sotres-Alvarez D, Davis SM, Arredondo EM, Van Horn L, Wylie-Rosett J, Sanchez-Johnsen L, Kaplan RC, Mossavar-Rahmani Y. Relationship between body fat and BMI in a US hispanic population-based cohort study: Results from HCHS/SOL. Obesity (Silver Spring). 2016 Jul;24(7):1561-71. doi: 10.1002/oby.21495. Epub 2016 May 17.

    PMID: 27184359DERIVED

  • Oelsner EC, Loehr LR, Henderson AG, Donohue KM, Enright PL, Kalhan R, Lo Cascio CM, Ries A, Shah N, Smith BM, Rosamond WD, Barr RG. Classifying Chronic Lower Respiratory Disease Events in Epidemiologic Cohort Studies. Ann Am Thorac Soc. 2016 Jul;13(7):1057-66. doi: 10.1513/AnnalsATS.201601-063OC.

    PMID: 27088163DERIVED

  • Mossavar-Rahmani Y, Jung M, Patel SR, Sotres-Alvarez D, Arens R, Ramos A, Redline S, Rock CL, Van Horn L. Eating behavior by sleep duration in the Hispanic Community Health Study/Study of Latinos. Appetite. 2015 Dec;95:275-84. doi: 10.1016/j.appet.2015.07.014. Epub 2015 Jul 16.

    PMID: 26189885DERIVED

  • Mossavar-Rahmani Y, Shaw PA, Wong WW, Sotres-Alvarez D, Gellman MD, Van Horn L, Stoutenberg M, Daviglus ML, Wylie-Rosett J, Siega-Riz AM, Ou FS, Prentice RL. Applying Recovery Biomarkers to Calibrate Self-Report Measures of Energy and Protein in the Hispanic Community Health Study/Study of Latinos. Am J Epidemiol. 2015 Jun 15;181(12):996-1007. doi: 10.1093/aje/kwu468. Epub 2015 May 20.

    PMID: 25995289DERIVED

  • Siega-Riz AM, Sotres-Alvarez D, Ayala GX, Ginsberg M, Himes JH, Liu K, Loria CM, Mossavar-Rahmani Y, Rock CL, Rodriguez B, Gellman MD, Van Horn L. Food-group and nutrient-density intakes by Hispanic and Latino backgrounds in the Hispanic Community Health Study/Study of Latinos. Am J Clin Nutr. 2014 Jun;99(6):1487-98. doi: 10.3945/ajcn.113.082685. Epub 2014 Apr 23.

    PMID: 24760972DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and DNA samples were collected.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Scott Solomon, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 12, 2014

Study Start

January 1, 2006

Primary Completion (Estimated)

November 1, 2032

Study Completion (Estimated)

November 1, 2032

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations

US(1)