NCT01418872

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,730

participants targeted

Target at P75+ for phase_4 obesity

Timeline
Completed

Started Jan 2012

Typical duration for phase_4 obesity

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

3 years

First QC Date

August 12, 2011

Last Update Submit

January 13, 2015

Conditions

ObesityCardiovascular Diseases

Keywords

ObesityCardiovascular Diseases PreventionPaediatrics

Outcome Measures

Primary Outcomes (1)

  • Change in Knowledge and attitudes in Cardiovascular Health

    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

    Before the intervention (baseline) and 7 days after and 6 months after the intervention.

Secondary Outcomes (1)

  • Body Mass Index (BMI)

    before the intervention (baseline) and 6 months after them.

Study Arms (2)

Healthy Breakfast

ACTIVE COMPARATOR

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

Didactic concerts

EXPERIMENTAL

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

Interventions

Didactic ConcertsOTHER

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.

Didactic concertsHealthy Breakfast

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agencia Lain Entralgo

Madrid, Madrid, 28013, Spain

Location

Related Publications (1)

  • Sanchez-Gomez LM, Fernandez-Luque MJ, Ruiz-Diaz L, Sanchez-Alcalde R, Sierra-Garcia B, Mayayo-Vicente S, Ruiz-Lopez M, Loeches-Belinchon P, Lopez-Gonzalez J, Gonzalez-Gamarra A, Gallego-Arenas A, Cubillo-Serna A, Gil-Juberias G, Perez-Cayuela P, Canedo-Arguelles CA, Garcia-Pascual JN, Ruiz-Chercoles E, Suarez-Fernandez C, Garcia-Polo I, Abad-Perez D, Ballesteros-Arribas JM, Izquierdo-Martinez M, Salvador-Alcaide E, Arribas-Vela AB, Alonso-Perez JM, Veja-Piris L, Rodriguez-Salvanes F, Novella-Arribas B. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project. BMC Public Health. 2012 Nov 23;12:1024. doi: 10.1186/1471-2458-12-1024.

    PMID: 23176593DERIVED

MeSH Terms

Conditions

ObesityCardiovascular Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Blanca Novella, PhD

    SERMAS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Médico familia SERMAS

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 17, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

ES(1)