- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060344
Hispanic Community Health Study / Study of Latinos (HCHS/SOL)
Hispanic Community Health Study / Study of Latinos (HCHS/SOL)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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This is a population-based cohort study of 16,400 Hispanic/Latinos. Objectives:
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Visit 2 data collection through 2019, preliminary and final analyses through 2019, Annual Follow-up through 2019
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Collaborators and Investigators
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
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
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Individual Participant Data Set
Information identifier: HCHS-SOLInformation 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.
- Study Forms
- 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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