Clinical trial NCT01416545: Children Education and Cardiovascular Risk Reduction in Their Parents
Official title: Children Education as Therapeutic Instrument for Cardiovascular Risk Reduction in Their Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction
Keywords: Primary Prevention
Cardiovascular disease
Child
Behavior modification
Activities, Educational
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-08-15
Enrollment: 520
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Basal evaluation before intervention (basline) and one-year after intitiation of intervention program.
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: InCor (Heart Institute) - Hospital das Clinicas da FMUSP
Study officials:
affiliation: University of Sao Paulo
name: Bruno Caramelli, MD, PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Luciana S Fornari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: