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CompletedNCT01416545CETICARPUpdated Mar 26, 2019

Children Education and Cardiovascular Risk Reduction in Their Parents

An interventional study of Educational program in cardiovascular prevention and Lifestyle counseling in Risk Reduction, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
5 Years to 11 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Risk Reduction

Keywords

  • Primary Prevention
  • Cardiovascular disease
  • Child
  • Behavior modification
  • Activities, Educational
03

In context

Risk Reduction Behavior

72 studies on the registry are indexed under Risk Reduction Behavior; 25 are open to participants now.

This study's enrollment of 520 is above the median of 200 across 66 interventional studies indexed under Risk Reduction Behavior.

Browse Risk Reduction Behavior studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
520 participants (actual)

Study arms

  • Active comparator
    Lifestyle counseling

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

    Behavioral: Educational program in cardiovascular prevention

  • Placebo comparator
    Control group

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

    Behavioral: Lifestyle counseling

Interventions

  • BehavioralEducational 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.

  • BehavioralLifestyle counseling

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

06

What researchers measure

Primary outcomes

  1. 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.

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

07

Study locations

1 site
  • InCor (Heart Institute) - Hospital das Clinicas da FMUSP
    São Paulo, 05403-900, Brazil
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Dec 2010 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2011
First posted
Aug 15, 2011
Start
Jan 2010
Primary completionActual
Dec 2010
CompletionActual
Jun 2011
Last update
Mar 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01416545
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Bruno Caramelli (Associated Professor of Cardiology, University of Sao Paulo) — Principal investigator
First posted
Aug 15, 2011
Start date
Jan 2010
Primary completion
Dec 2010
Completion
Jun 2011
Last update
Mar 26, 2019

Study contacts

Bruno Caramelli, MD, PhD
study chair · University of Sao Paulo
Luciana S Fornari, MD, PhD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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