Study on Nutrition and Cardiovascular Risk in Spain. (ENRICA)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Jose R Banegas, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier:
NCT01133093
First received: May 27, 2010
Last updated: May 5, 2016
Last verified: May 2016
  Purpose

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)

Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Study on Nutrition and Cardiovascular Risk in Spain.

Further study details as provided by Universidad Autonoma de Madrid:

Primary Outcome Measures:
  • Cardiovascular Risk Factors Control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Use of health care services [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Blood and urine samples

Enrollment: 11991
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community sample representative of the non-institutionalized Spanish population
Criteria

Inclusion Criteria:

  • Non-institutionalized Spanish resident
  • 18 years and over

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133093

Locations
Spain
Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid
Madrid, Spain, 28029
Sponsors and Collaborators
Universidad Autonoma de Madrid
Sanofi
Investigators
Principal Investigator: Jose R Banegas, MD, PhD Department of Preventive Medicine and Public Health, Universidad Autonoma de Madrid
Principal Investigator: Fernando Rodriguez-Artalejo, MD, PhD Department of Preventive Medicine and Public Health, Universidad Autonoma de Madrid
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose R Banegas, Professor of Preventive Medicine and Public Health, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT01133093     History of Changes
Other Study ID Numbers: ENRICA 
Study First Received: May 27, 2010
Last Updated: May 5, 2016
Health Authority: Spain: Ministry of Health
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Universidad Autonoma de Madrid:
Cardiovascular risk factors
Nutritional assessment
Epidemiology

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2016