Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-28 @ 6:22 PM
Study NCT ID:
NCT01133093
Status:
COMPLETED
Last Update Posted:
2016-05-06
First Post:
2010-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Nutrition and Cardiovascular Risk in Spain.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11991}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2010-05-27', 'studyFirstSubmitQcDate': '2010-05-27', 'lastUpdatePostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Risk Factors Control', 'timeFrame': '2 years'}, {'measure': 'Health-related quality of life', 'timeFrame': '2 years'}, {'measure': 'Use of health care services', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiovascular risk factors', 'Nutritional assessment', 'Epidemiology'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '22151906', 'type': 'RESULT', 'citation': 'Gutierrez-Fisac JL, Guallar-Castillon P, Leon-Munoz LM, Graciani A, Banegas JR, Rodriguez-Artalejo F. Prevalence of general and abdominal obesity in the adult population of Spain, 2008-2010: the ENRICA study. Obes Rev. 2012 Apr;13(4):388-92. doi: 10.1111/j.1467-789X.2011.00964.x. Epub 2011 Dec 12.'}, {'pmid': '22483404', 'type': 'RESULT', 'citation': 'Guallar-Castillon P, Gil-Montero M, Leon-Munoz LM, Graciani A, Bayan-Bravo A, Taboada JM, Banegas JR, Rodriguez-Artalejo F. Magnitude and management of hypercholesterolemia in the adult population of Spain, 2008-2010: The ENRICA Study. Rev Esp Cardiol (Engl Ed). 2012 Jun;65(6):551-8. doi: 10.1016/j.recesp.2012.02.005. Epub 2012 Apr 5.'}, {'pmid': '22875552', 'type': 'RESULT', 'citation': 'Leon-Munoz LM, Guallar-Castillon P, Graciani A, Lopez-Garcia E, Mesas AE, Aguilera MT, Banegas JR, Rodriguez-Artalejo F. Adherence to the Mediterranean diet pattern has declined in Spanish adults. J Nutr. 2012 Oct;142(10):1843-50. doi: 10.3945/jn.112.164616. Epub 2012 Aug 8.'}, {'pmid': '22949530', 'type': 'RESULT', 'citation': 'Banegas JR, Graciani A, de la Cruz-Troca JJ, Leon-Munoz LM, Guallar-Castillon P, Coca A, Ruilope LM, Rodriguez-Artalejo F. Achievement of cardiometabolic goals in aware hypertensive patients in Spain: a nationwide population-based study. Hypertension. 2012 Oct;60(4):898-905. doi: 10.1161/HYPERTENSIONAHA.112.193078. Epub 2012 Sep 4.'}, {'pmid': '22577840', 'type': 'RESULT', 'citation': 'Mesas AE, Leon-Munoz LM, Guallar-Castillon P, Graciani A, Gutierrez-Fisac JL, Lopez-Garcia E, Aguilera MT, Banegas JR, Rodriguez-Artalejo F. Obesity-related eating behaviours in the adult population of Spain, 2008-2010. Obes Rev. 2012 Oct;13(10):858-67. doi: 10.1111/j.1467-789X.2012.01005.x. Epub 2012 May 11.'}, {'pmid': '22907330', 'type': 'RESULT', 'citation': 'Lundelin K, Graciani A, Garcia-Puig J, Guallar-Castillon P, Taboada JM, Rodriguez-Artalejo F, Banegas JR. Knowledge of stroke warning symptoms and intended action in response to stroke in Spain: a nationwide population-based study. Cerebrovasc Dis. 2012;34(2):161-8. doi: 10.1159/000341408. Epub 2012 Aug 17.'}, {'pmid': '23637851', 'type': 'RESULT', 'citation': 'Navarro-Vidal B, Banegas JR, Leon-Munoz LM, Rodriguez-Artalejo F, Graciani A. Achievement of cardiometabolic goals among diabetic patients in Spain. A nationwide population-based study. PLoS One. 2013 Apr 18;8(4):e61549. doi: 10.1371/journal.pone.0061549. Print 2013.'}, {'pmid': '23300271', 'type': 'RESULT', 'citation': 'Graciani A, Leon-Munoz LM, Guallar-Castillon P, Rodriguez-Artalejo F, Banegas JR. Cardiovascular health in a southern Mediterranean European country: a nationwide population-based study. Circ Cardiovasc Qual Outcomes. 2013 Jan 1;6(1):90-8. doi: 10.1161/CIRCOUTCOMES.112.967893. Epub 2013 Jan 8.'}, {'pmid': '24125427', 'type': 'RESULT', 'citation': 'Lopez-Garcia E, Guallar-Castillon P, Leon-Munoz L, Rodriguez-Artalejo F. Prevalence and determinants of metabolically healthy obesity in Spain. Atherosclerosis. 2013 Nov;231(1):152-7. doi: 10.1016/j.atherosclerosis.2013.09.003. Epub 2013 Sep 18.'}, {'pmid': '24164355', 'type': 'RESULT', 'citation': 'Soler-Vila H, Galan I, Valencia-Martin JL, Leon-Munoz LM, Guallar-Castillon P, Rodriguez-Artalejo F. Binge drinking in Spain, 2008-2010. Alcohol Clin Exp Res. 2014 Mar;38(3):810-9. doi: 10.1111/acer.12275. Epub 2013 Oct 24.'}, {'pmid': '24795130', 'type': 'RESULT', 'citation': 'Graciani A, Rodriguez-Artalejo F, Navarro-Vidal B, Banegas JR. Glycemic control using individualized targets among diabetic patients in Spain: a population-based study. Rev Esp Cardiol (Engl Ed). 2014 Feb;67(2):151-3. doi: 10.1016/j.rec.2013.07.018. Epub 2013 Dec 4. No abstract available.'}, {'pmid': '24774729', 'type': 'RESULT', 'citation': 'Guallar-Castillon P, Perez RF, Lopez Garcia E, Leon-Munoz LM, Aguilera MT, Graciani A, Gutierrez-Fisac JL, Banegas JR, Rodriguez-Artalejo F. Magnitude and management of metabolic syndrome in Spain in 2008-2010: the ENRICA study. Rev Esp Cardiol (Engl Ed). 2014 May;67(5):367-73. doi: 10.1016/j.rec.2013.08.014. Epub 2014 Jan 14.'}, {'pmid': '25288520', 'type': 'RESULT', 'citation': 'Leon-Munoz LM, Galan I, Donado-Campos J, Sanchez-Alonso F, Lopez-Garcia E, Valencia-Martin JL, Guallar-Castillon P, Rodriguez-Artalejo F. Patterns of alcohol consumption in the older population of Spain, 2008-2010. J Acad Nutr Diet. 2015 Feb;115(2):213-224. doi: 10.1016/j.jand.2014.08.017. Epub 2014 Oct 5.'}, {'pmid': '31623843', 'type': 'DERIVED', 'citation': 'Blanco-Rojo R, Sandoval-Insausti H, Lopez-Garcia E, Graciani A, Ordovas JM, Banegas JR, Rodriguez-Artalejo F, Guallar-Castillon P. Consumption of Ultra-Processed Foods and Mortality: A National Prospective Cohort in Spain. Mayo Clin Proc. 2019 Nov;94(11):2178-2188. doi: 10.1016/j.mayocp.2019.03.035. Epub 2019 Oct 14.'}, {'pmid': '30737049', 'type': 'DERIVED', 'citation': 'Laclaustra M, Rodriguez-Artalejo F, Guallar-Castillon P, Banegas JR, Graciani A, Garcia-Esquinas E, Lopez-Garcia E. The inflammatory potential of diet is related to incident frailty and slow walking in older adults. Clin Nutr. 2020 Jan;39(1):185-191. doi: 10.1016/j.clnu.2019.01.013. Epub 2019 Jan 24.'}, {'pmid': '21821340', 'type': 'DERIVED', 'citation': 'Rodriguez-Artalejo F, Graciani A, Guallar-Castillon P, Leon-Munoz LM, Zuluaga MC, Lopez-Garcia E, Gutierrez-Fisac JL, Taboada JM, Aguilera MT, Regidor E, Villar-Alvarez F, Banegas JR. [Rationale and methods of the study on nutrition and cardiovascular risk in Spain (ENRICA)]. Rev Esp Cardiol. 2011 Oct;64(10):876-82. doi: 10.1016/j.recesp.2011.05.019. Epub 2011 Aug 6. Spanish.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the distribution, awareness and control of main cardiovascular risk factors in the Spanish population. The main study variables are:\n\n* Lifestyles (tobacco, alcohol, nutrition, physical activity)\n* Biological risk factors either well-established (blood lipids, glucose, insulin and blood pressure) or emergent (leptin, C-reactive protein and other markers of inflammation)', 'detailedDescription': 'Data collection comprised 3 sequential stages:\n\n1. computer-assisted telephone interview to obtain information on lifestyle, knowledge and attitudes about cardiovascular disease risk factors, and the signs and symptoms of heart attack and stroke, subjective health, and morbidity;\n2. first homevisit, to collect blood and urine samples for analysis by a central laboratory;\n3. second home visit, to measure anthropometric variables and blood pressure and to administer a computer-assisted dietary history; data on functional limitations are also collected from participants aged 65 years and older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample representative of the non-institutionalized Spanish population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-institutionalized Spanish resident\n* 18 years and over\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01133093', 'acronym': 'ENRICA', 'briefTitle': 'Study on Nutrition and Cardiovascular Risk in Spain.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Madrid'}, 'officialTitle': 'Study on Nutrition and Cardiovascular Risk in Spain.', 'orgStudyIdInfo': {'id': 'ENRICA'}}, 'contactsLocationsModule': {'locations': [{'zip': '28029', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Jose R Banegas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Preventive Medicine and Public Health, Universidad Autonoma de Madrid'}, {'name': 'Fernando Rodriguez-Artalejo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Preventive Medicine and Public Health, Universidad Autonoma de Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Preventive Medicine and Public Health', 'investigatorFullName': 'Jose R Banegas', 'investigatorAffiliation': 'Universidad Autonoma de Madrid'}}}}