Study on Nutrition and Cardiovascular Risk in Spain.

Cardiovascular Disease Clinical Trial

— ENRICA  

Official title:

Study on Nutrition and Cardiovascular Risk in Spain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133093
• Other study ID #: ENRICA
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: May 5, 2016
• Start date: March 2008
• Est. completion date: October 2010

Study information

• Verified date: May 2016
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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:

• Lifestyles (tobacco, alcohol, nutrition, physical activity)

• Biological risk factors either well-established (blood lipids, glucose, insulin and blood pressure) or emergent (leptin, C-reactive protein and other markers of inflammation)

Description:

Data collection comprised 3 sequential stages:

1. 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;

2. first homevisit, to collect blood and urine samples for analysis by a central laboratory;

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11991
• Est. completion date: October 2010
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-institutionalized Spanish resident

• 18 years and over

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
Spain	Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid	Sanofi

Country where clinical trial is conducted

Spain, 

References & Publications (13)

Banegas JR, Graciani A, de la Cruz-Troca JJ, León-Muñoz LM, Guallar-Castillón P, Coca A, Ruilope LM, Rodríguez-Artalejo F. Achievement of cardiometabolic goals in aware hypertensive patients in Spain: a nationwide population-based study. Hypertension. 201 — View Citation

Graciani A, León-Muñoz LM, Guallar-Castillón P, Rodríguez-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/CI — View Citation

Graciani A, Rodríguez-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 — View Citation

Guallar-Castillón P, Gil-Montero M, León-Muñoz LM, Graciani A, Bayán-Bravo A, Taboada JM, Banegas JR, Rodríguez-Artalejo F. Magnitude and management of hypercholesterolemia in the adult population of Spain, 2008-2010: The ENRICA Study. Rev Esp Cardiol (En — View Citation

Guallar-Castillón P, Pérez RF, López García E, León-Muñoz LM, Aguilera MT, Graciani A, Gutiérrez-Fisac JL, Banegas JR, Rodríguez-Artalejo F. Magnitude and management of metabolic syndrome in Spain in 2008-2010: the ENRICA study. Rev Esp Cardiol (Engl Ed). — View Citation

Gutiérrez-Fisac JL, Guallar-Castillón P, León-Muñoz LM, Graciani A, Banegas JR, Rodríguez-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/ — View Citation

León-Muñoz LM, Galán I, Donado-Campos J, Sánchez-Alonso F, López-García E, Valencia-Martín JL, Guallar-Castillón P, Rodríguez-Artalejo F. Patterns of alcohol consumption in the older population of Spain, 2008-2010. J Acad Nutr Diet. 2015 Feb;115(2):213-24 — View Citation

León-Muñoz LM, Guallar-Castillón P, Graciani A, López-García E, Mesas AE, Aguilera MT, Banegas JR, Rodríguez-Artalejo F. Adherence to the Mediterranean diet pattern has declined in Spanish adults. J Nutr. 2012 Oct;142(10):1843-50. Epub 2012 Aug 8. — View Citation

Lopez-Garcia E, Guallar-Castillon P, Leon-Muñoz 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. — View Citation

Lundelin K, Graciani A, García-Puig J, Guallar-Castillón P, Taboada JM, Rodríguez-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;3 — View Citation

Mesas AE, León-Muñoz LM, Guallar-Castillón P, Graciani A, Gutiérrez-Fisac JL, López-García E, Aguilera MT, Banegas JR, Rodríguez-Artalejo F. Obesity-related eating behaviours in the adult population of Spain, 2008-2010. Obes Rev. 2012 Oct;13(10):858-67. d — View Citation

Navarro-Vidal B, Banegas JR, León-Muñoz LM, Rodríguez-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. — View Citation

Soler-Vila H, Galán I, Valencia-Martín JL, León-Muñoz LM, Guallar-Castillón P, Rodríguez-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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Risk Factors Control		2 years	No
Primary	Health-related quality of life		2 years	No
Primary	Use of health care services		2 years	No