Children Education and Cardiovascular Risk Reduction in Their Parents

Not Applicable

Completed

• Conditions: Risk Reduction
• Interventions: Behavioral: Lifestyle counseling; Behavioral: Educational program in cardiovascular prevention

• Registration Number: NCT01416545
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-15
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-23
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Lifestyle counseling	The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).
Lifestyle counseling	Educational program in cardiovascular prevention	Children received the same educational material for their parents and, additionaly, were exposed to a weekly educational program directed for cardiovascular prevention.

Primary Outcome Measures

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

Trial Locations

Locations (1)

InCor (Heart Institute) - Hospital das Clinicas da FMUSP; 🇧🇷 Sao Paulo, Brazil