NCT01416545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

August 11, 2011

Last Update Submit

March 23, 2019

Conditions

Risk Reduction

Keywords

Primary PreventionCardiovascular diseaseChildBehavior modificationActivities, Educational

Outcome Measures

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.

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

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Educational program in cardiovascular preventionBEHAVIORAL

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
Lifestyle counselingBEHAVIORAL

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

Control group

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • students aged 6 to 10 years old and their parents of a single private school of the city of Sap Paulo, Brazil

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InCor (Heart Institute) - Hospital das Clinicas da FMUSP

São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Risk Reduction BehaviorCardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bruno Caramelli, MD, PhD

    University of Sao Paulo

    STUDY CHAIR

  • Luciana S Fornari, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor of Cardiology

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 15, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

BR(1)