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

May 5, 2016 updated by: Jose R Banegas, Universidad Autonoma de Madrid

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)

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

11991

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28029
        • Department of Preventive Medicine and Public Health. Universidad Autonoma de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community sample representative of the non-institutionalized Spanish population

Description

Inclusion Criteria:

  • Non-institutionalized Spanish resident
  • 18 years and over

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular Risk Factors Control
Time Frame: 2 years
2 years
Health-related quality of life
Time Frame: 2 years
2 years
Use of health care services
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Madrid

Collaborators

Sanofi

Investigators

  • Principal Investigator: Jose R Banegas, MD, PhD, Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid
  • Principal Investigator: Fernando Rodríguez-Artalejo, MD, PhD, Department of Preventive Medicine and Public Health, Universidad Autónoma de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENRICA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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