Clinical trial NCT01418872: A Clinical Trial Of Two Educational Strategies In Cardiovascular Health In Child Population
Official title: A Cluster-Randomized Clinical Trial Of Two Educational Strategies In Cardiovascular Health (CVH) In Child Population. The Savinghearts Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Cardiovascular Diseases
Keywords: Obesity
Cardiovascular Diseases Prevention
Paediatrics
Lead sponsor: Agencia Lain Entralgo
Sponsor class: OTHER_GOV
Collaborators: name: Gerencia de Atención Primaria, Madrid
name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Instituto de Salud Carlos III
name: Ministerio de Sanidad, Servicios Sociales e Igualdad
name: Comunidad de Madrid
First posted: 2011-08-17
Enrollment: 1730
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Change in Knowledge and attitudes in Cardiovascular Health
timeFrame: Before the intervention (baseline) and 7 days after and 6 months after the intervention.
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: before the intervention (baseline) and 6 months after them.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Agencia Lain Entralgo
Study officials:
affiliation: SERMAS
name: Blanca Novella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.