Children Education and Cardiovascular Risk Reduction in Their Parents

Risk Reduction Clinical Trial

— CETICARP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416545
• Other study ID #: 2009/17450-3
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Risk Reduction

Intervention

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

Locations

Country	Name	City	State
Brazil	InCor (Heart Institute) - Hospital das Clinicas da FMUSP	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.