Children Education and Cardiovascular Risk Reduction in Their Parents

NCT ID: NCT01416545

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Risk Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Lifestyle counseling

Children received the same educational material for their parents and, additionaly, were exposed to a weekly educational program directed for cardiovascular prevention.

Group Type ACTIVE_COMPARATOR

Educational program in cardiovascular prevention

Intervention Type BEHAVIORAL

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.

Control group

The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).

Group Type PLACEBO_COMPARATOR

Lifestyle counseling

Intervention Type BEHAVIORAL

The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).

Interventions

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Educational program in cardiovascular prevention

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.

Intervention Type BEHAVIORAL

Lifestyle counseling

The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Caramelli

Associated Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Caramelli, MD, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Luciana S Fornari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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InCor (Heart Institute) - Hospital das Clinicas da FMUSP

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2009/17450-3

Identifier Type: -

Identifier Source: org_study_id

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