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Clinical Trials/NCT01133093
NCT01133093CompletedNot Applicable

Study on Nutrition and Cardiovascular Risk in Spain.

Universidad Autonoma de Madrid1 site in 1 country11,991 target enrollmentStarted: March 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
11,991
Locations
1
Primary Endpoint
Health-related quality of life

Study Overview

Brief 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)

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 Design

Study Type
Observational
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Non-institutionalized Spanish resident
  • 18 years and over

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Health-related quality of life

Time Frame: 2 years

Cardiovascular Risk Factors Control

Time Frame: 2 years

Use of health care services

Time Frame: 2 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jose R Banegas

Professor of Preventive Medicine and Public Health

Universidad Autonoma de Madrid

Study Sites (1)

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