Children Education and Cardiovascular Risk Reduction in Their Parents (CETICARP)

University of Sao Paulo

Status: Completed

Conditions: Risk Reduction

Treatments: Behavioral: Lifestyle counseling; Behavioral: Educational program in cardiovascular prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT01416545

2009/17450-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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520 participants in 2 patient groups, including a placebo group

Lifestyle counseling

Active Comparator group

Description:

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

Treatment:

Behavioral: Educational program in cardiovascular prevention

Control group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Lifestyle counseling