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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01416545
First received: August 11, 2011
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Risk Reduction
Behavioral: Educational program in cardiovascular prevention
Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Children Education as Therapeutic Instrument for Cardiovascular Risk Reduction in Their Parents

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 520
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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
The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).

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

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416545

Locations
Brazil
InCor (Heart Institute) - Hospital das Clinicas da FMUSP
Sao Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Bruno Caramelli, MD, PhD University of Sao Paulo
Principal Investigator: Luciana S Fornari, MD, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Bruno Caramelli, MD,PhD, Heart Institute, University of Sao Paulo Medical School
ClinicalTrials.gov Identifier: NCT01416545     History of Changes
Other Study ID Numbers: 2009/17450-3
Study First Received: August 11, 2011
Last Updated: August 12, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Primary Prevention
Cardiovascular disease
Child
Behavior modification
Activities, Educational

ClinicalTrials.gov processed this record on April 17, 2014