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Open Access Study protocol

A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

Luis María Sánchez-Gómez1, María Jesús Fernández-Luque2, Lourdes Ruiz-Díaz3, Rosa Sánchez-Alcalde3, Belén Sierra-García3, Soledad Mayayo-Vicente3, Marta Ruiz-López3, Pilar Loeches-Belinchón3, Javier López-Gónzález4, Amelia González-Gamarra3, Angela Gallego-Arenas3, Ana Cubillo-Serna3, Gema Gil-Juberias3, Pilar Pérez-Cayuela5, Celina Arana Cañedo-Arguelles3, Julia Natividad García-Pascual3, Esther Ruiz-Chércoles3, Carmen Suarez-Fernández6, Iluminada Garcia-Polo6, Daniel Abad-Perez6, Juan M Ballesteros-Arribas7, Maravillas Izquierdo-Martínez8, Elena Salvador-Alcaide9, Ana B Arribas-Vela9, Juan M Alonso-Pérez9, Lorena Veja-Piris10, Francisco Rodríguez-Salvanés10 and Blanca Novella-Arribas3*

Author Affiliations

1 Agencia de Evaluación de Tecnología Sanitarias (AETS), ISCIII. Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa (IP). C/ Monforte de Lemos 5, Madrid, 28029, Spain

2 Área de Formación Especializada, Agencia Laín Entralgo, Consejería de Sanidad, Comunidad de Madrid, Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa (IP), C/ Gran Vía 27, Madrid, 28013, Spain

3 D.G. de Atención Primaria, SERMAS Consejería de Sanidad, Comunidad de Madrid, Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa (IP). Red Temática de Investigación en Enfermedades Cardiovasculares (RECAVA), Pza. Carlos Trías Bertrán, 7, Madrid, 28020, Spain

4 FREMAP, Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP), Avenida Pablo Iglesias 36-40, Madrid, 28039, Spain

5 D. G. de Gestión Económica y de Compras de Productos Sanitarios y Farmacéuticos, Consejería de Sanidad, Comunidad de Madrid, Pza. Carlos Trías Bertrán 7, Madrid, 28020, Spain

6 Servicio de Medicina Interna, Hospital Universitario de la Princesa. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). Red Temática de Investigación en Enfermedades Cardiovasculares (RECAVA), (C/ Diego de León 62), Madrid, (28006), Spain

7 Ministerio de Sanidad, Política Social e Igualdad, (Paseo del Prado 18-20), Madrid, (28014), Spain

8 Subdirección de Promoción de la Salud y Prevención, D.G. de Atención Primaria Madrid, SERMAS, Consejería de Sanidad, Comunidad de Madrid, (C/ Julián Camarillo, 4B), Madrid, (28037), Spain

9 Consejería de Educación y Empleo, Comunidad de Madrid, (C/ Alcalá, 30 – 32), Madrid, (28021), Spain

10 Unidad de Información Clínico Asistencial. Servicio de Admisión y Documentación Clínica, Hospital Universitario de la Princesa. Instituto de Investigación sanitaria del Hospital Universitario de La Princesa (IP). Red Temática de Investigación en Enfermedades Cardiovasculares (RECAVA), (C/ Diego de León 62), Madrid, 28006, Spain

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BMC Public Health 2012, 12:1024  doi:10.1186/1471-2458-12-1024

Published: 23 November 2012

Abstract

Background

This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years.

Methods/design

This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30) will be randomly assigned to one of two groups: 1) Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2) Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children) was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis.

Discussion

The intervention providing the best results could be recommended as part of health education for young schoolchildren.

Trial registration

Clinicaltrials.gov: NCT01418872

Keywords:
Cluster randomised clinical trial; Cluster analysis; Cardiovascular diseases; Child obesity; Educational concerts; Healthy strategies; NAOS strategy