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Clinical Trials/NCT01416545
NCT01416545
Completed
Not Applicable

Children Education as Therapeutic Instrument for Cardiovascular Risk Reduction in Their Parents

University of Sao Paulo1 site in 1 country520 target enrollmentJanuary 2010
ConditionsRisk Reduction

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Risk Reduction
Sponsor
University of Sao Paulo
Enrollment
520
Locations
1
Primary Endpoint
Changes in cardiovascular risk measured by Framingham score index in parents whose children have participated (or not) in a multidisciplinary educational intervention for prevention of cardiovascular diseases.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study aims to evaluate if a multidisciplinary educational program in primary cardiovascular prevention for children could improve the Framingham Score index of their parents after one year.

Detailed Description

Students aging 6 to 10 years old were exposed to two different approaches in the city of Sao Paulo, Brazil. For the students of the morning period (control group) we delivered written educational material for their parents in the beginning and middle of the year 2010 about healthy lifestyle (nutrition, exercise and smoke quitting). The students of the afternoon period (intervention group) received the same educational material for their parents and the children were exposed to a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
June 2011
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bruno Caramelli

Associated Professor of Cardiology

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • students aged 6 to 10 years old and their parents of a single private school of the city of Sap Paulo, Brazil

Exclusion Criteria

  • children and/or parents that do not agree to participate of the study;
  • children and/or parents that are taking immunosupressive drugs;
  • parents with known atherosclerotic disease such as angina or myocardial infaction, stroke, and/or peripheral arterial disease;
  • parents with untreated hypothyroidism, untreated hypopituitarosm, nefrotic syndrome, chronic renal failure, congenital biliary allof, storage diseases, lupus and/oracquired immunodeficiency syndrome.

Outcomes

Primary Outcomes

Changes in cardiovascular risk measured by Framingham score index in parents whose children have participated (or not) in a multidisciplinary educational intervention for prevention of cardiovascular diseases.

Time Frame: Basal evaluation before intervention (basline) and one-year after intitiation of intervention program.

Study Sites (1)

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