A Clinical Trial Of Two Educational Strategies In Cardiovascular Health In Child Population (SAVINHEARTS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Agencia Lain Entralgo.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Gerencia de Atención Primaria, Madrid
Hospital Universitario de la Princesa
Instituto de Salud Carlos III
MINISTERIO DE SANIDAD, POLITICA SOCIAL E IGUALDAD.ESPAÑA
CONSEJERIA DE EDUCACIÓN. COMUNIDAD DE MADRID
Information provided by:
Agencia Lain Entralgo
ClinicalTrials.gov Identifier:
NCT01418872
First received: August 12, 2011
Last updated: August 16, 2011
Last verified: August 2011
  Purpose

AIM: To evaluate the effectiveness of two strategies in cardiovascular risk in children 2º grade in the community of Madrid.

DESIGN: cluster-randomized trial with blinded evaluator SCOPE AND SUBJECTS OF STUDY: Children of both sexes enrolled in 2º grade in public schools in the community of Madrid. Rate exclusion criteria INTERVENTION: Schools were randomly assigned to two groups: an experimental group that the investigators organized a concert teaching focused on messages cardio, a second group or control group to which they will host a healthy breakfast as it has been offering the Community of Madrid .

MEASUREMENTS: The primary end result is the increase of correct answers on a standardized test to be administered before and after the activity.

Secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall weight and center from before the intervention at 6 months of it.


Condition Intervention Phase
Obesity
Cardiovascular Diseases
Other: Didactic Concerts
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Cluster-Randomized Clinical Trial Of Two Educational Strategies In Cardiovascular Health (CVH) In Child Population. The Savinghearts Project

Resource links provided by NLM:


Further study details as provided by Agencia Lain Entralgo:

Primary Outcome Measures:
  • Change in Knowledge and attitudes in Cardiovascular Health [ Time Frame: Before the intervention (baseline) and 7 days after and 6 months after the intervention. ] [ Designated as safety issue: No ]
    The primary outcome variable will be the changes in healthy heart knowledge and attitudes in children in 2º grade of primary school. We will measure this primary outcome variable using 2 modified INUTCAM questionnaires


Secondary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: before the intervention (baseline) and 6 months after them. ] [ Designated as safety issue: No ]
    The secondary outcome variable will be BMI measured at the moment of the intervention and 6 months after it.


Estimated Enrollment: 1500
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Breakfast

The activity will be performed at the school dining hall, scheduling 1 hour for breakfast,within the school hours, with maximum 50 children per turn It involves placing a table mat, a cup, a plate and two slices of bread per child, plus 1-liter bottle of milk for each four children and 1-liter bottle of oil for each twelve. The dining hall will be all set up before the students come in.

Participatory lesson : Ideal number of daily meals, Importance of daily breakfast for the activity, Time for breakfast, Basic components for a healthy breakfast, The role of cereals at breakfast, The role of dairy products at breakfast,The role of fruits at breakfast, Importance of exercise for cardiovascular health, The role of unhealthy habits: sedentary lifestyle.

The students will be invited to take the table mat and the cup, in which is inscribed: "I am a heart-saver", so that they take them home and serve as a reminder of the activity.

A pamphlet of the NAOS strategy will also be delivered.

Other: Didactic Concerts

The activity we are going to test consists in a communication and spreading strategy.

The activity will take place in the auditorium of the school, scheduling 1 hour for concert, within the school hours, and having maximum 50 children per turn.

Preparation of the auditorium for the activity 5 classic musical pieces and a story as a conducting thread. Children will be asked to clap and raise hands to participate in the mission of becoming a heart-savers: Ideal number of daily meals, Importance of daily breakfast for the activity, Time for breakfast, Basic components for a healthy breakfast, The role of cereals at breakfast, dairy products in breakfast, fruits at breakfast, Importance of exercise for cardiovascular health, The role of sedentary lifestyle.

Students will be invited to take the playbill as a bookmark format and a cup is inscribed: "I am a heart-saver", so that they take them home and serve as a reminder of the activity. A NAOS strategy pamphlet will also be delivered.

Experimental: Didactic concerts

The activity we are going to test consists in a communication and spreading strategy.

The activity will take place in the auditorium of the school, scheduling 1 hour for concert, within the school hours, and having maximum 50 children per turn.

Preparation of the auditorium for the activity 5 classic musical pieces and a story as a conducting thread. Children will be asked to clap and raise hands to participate in the mission of becoming a heart-savers: Ideal number of daily meals, Importance of daily breakfast for the activity, Time for breakfast, Basic components for a healthy breakfast, The role of cereals at breakfast, dairy products in breakfast, fruits at breakfast, Importance of exercise for cardiovascular health, The role of sedentary lifestyle.

Students will be invited to take the playbill as a bookmark format and a cup is inscribed: "I am a heart-saver", so that they take them home and serve as a reminder of the activity. A NAOS strategy pamphlet will also be delivered.

Other: Didactic Concerts

The activity we are going to test consists in a communication and spreading strategy.

The activity will take place in the auditorium of the school, scheduling 1 hour for concert, within the school hours, and having maximum 50 children per turn.

Preparation of the auditorium for the activity 5 classic musical pieces and a story as a conducting thread. Children will be asked to clap and raise hands to participate in the mission of becoming a heart-savers: Ideal number of daily meals, Importance of daily breakfast for the activity, Time for breakfast, Basic components for a healthy breakfast, The role of cereals at breakfast, dairy products in breakfast, fruits at breakfast, Importance of exercise for cardiovascular health, The role of sedentary lifestyle.

Students will be invited to take the playbill as a bookmark format and a cup is inscribed: "I am a heart-saver", so that they take them home and serve as a reminder of the activity. A NAOS strategy pamphlet will also be delivered.


  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2º grade of primary school students present the day of the activity, whose parents had signed the informed consent to participate in the study and with no exclusion criteria at the moment of the intervention

Exclusion Criteria:

  • Students with food allergies or intolerances.
  • Students with severe hearing impairment (not corrected).
  • Students whose parents didn´t sign the informed consent to participate in the study.
  • Students with a poor understanding of oral and written language.
  • To have previously received healthy breakfasts interventions or educational concerts.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418872

Contacts
Contact: Blanca Novella, PhD 0034606368183 blancanovella@gmail.com
Contact: Luis María Sanchez, MSc 0034687710387 lmsanchezg@yahoo.com

Locations
Spain
Agencia Lain Entralgo Not yet recruiting
Madrid, Spain, 28013
Contact: Blanca Novella, PhD    0034606368183    blancanovella@gmail.com   
Contact: Luis María Sanchez, MSc    0034687710387    lmsanchezg@yahoo.com   
Principal Investigator: Blanca Novella, PhD         
Sponsors and Collaborators
Agencia Lain Entralgo
Gerencia de Atención Primaria, Madrid
Hospital Universitario de la Princesa
Instituto de Salud Carlos III
MINISTERIO DE SANIDAD, POLITICA SOCIAL E IGUALDAD.ESPAÑA
CONSEJERIA DE EDUCACIÓN. COMUNIDAD DE MADRID
Investigators
Principal Investigator: Blanca Novella, PhD SERMAS
  More Information

No publications provided by Agencia Lain Entralgo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BLANCA NOVELLA ARRIBAS, SERMAS. CONSEJERÍA DE SANIDAD. COMUNIDAD DE MADRID
ClinicalTrials.gov Identifier: NCT01418872     History of Changes
Other Study ID Numbers: 1668-BK-148
Study First Received: August 12, 2011
Last Updated: August 16, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Agencia Lain Entralgo:
Obesity
Cardiovascular Diseases Prevention
Paediatrics

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014