title: A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project.
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
  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.
  
  
  CONCLUSIONS
  The intervention providing the best results could be recommended as part of health education for young schoolchildren.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT01418872.
authors.affiliation: 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.
authors.forename: Luis María
authors.initials: LM
authors.lastname: Sánchez-Gómez
authors.forename: María Jesús
authors.initials: MJ
authors.lastname: Fernández-Luque
authors.forename: Lourdes
authors.initials: L
authors.lastname: Ruiz-Díaz
authors.forename: Rosa
authors.initials: R
authors.lastname: Sánchez-Alcalde
authors.forename: Belén
authors.initials: B
authors.lastname: Sierra-García
authors.forename: Soledad
authors.initials: S
authors.lastname: Mayayo-Vicente
authors.forename: Marta
authors.initials: M
authors.lastname: Ruiz-López
authors.forename: Pilar
authors.initials: P
authors.lastname: Loeches-Belinchón
authors.forename: Javier
authors.initials: J
authors.lastname: López-Gónzález
authors.forename: Amelia
authors.initials: A
authors.lastname: González-Gamarra
authors.forename: Angela
authors.initials: A
authors.lastname: Gallego-Arenas
authors.forename: Ana
authors.initials: A
authors.lastname: Cubillo-Serna
authors.forename: Gema
authors.initials: G
authors.lastname: Gil-Juberias
authors.forename: Pilar
authors.initials: P
authors.lastname: Pérez-Cayuela
authors.forename: Celina Arana
authors.initials: CA
authors.lastname: Cañedo-Arguelles
authors.forename: Julia Natividad
authors.initials: JN
authors.lastname: García-Pascual
authors.forename: Esther
authors.initials: E
authors.lastname: Ruiz-Chércoles
authors.forename: Carmen
authors.initials: C
authors.lastname: Suarez-Fernández
authors.forename: Iluminada
authors.initials: I
authors.lastname: Garcia-Polo
authors.forename: Daniel
authors.initials: D
authors.lastname: Abad-Perez
authors.forename: Juan M
authors.initials: JM
authors.lastname: Ballesteros-Arribas
authors.forename: Maravillas
authors.initials: M
authors.lastname: Izquierdo-Martínez
authors.forename: Elena
authors.initials: E
authors.lastname: Salvador-Alcaide
authors.forename: Ana B
authors.initials: AB
authors.lastname: Arribas-Vela
authors.forename: Juan M
authors.initials: JM
authors.lastname: Alonso-Pérez
authors.forename: Lorena
authors.initials: L
authors.lastname: Veja-Piris
authors.forename: Francisco
authors.initials: F
authors.lastname: Rodríguez-Salvanés
authors.forename: Blanca
authors.initials: B
authors.lastname: Novella-Arribas
mesh_terms: D062408:Breakfast; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002648:Child; D016000:Cluster Analysis; D005260:Female; D005500:Follow-Up Studies; D006266:Health Education / Q000379:methods*; D007722:Health Knowledge, Attitudes, Practice; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D009146:Music; D009765:Obesity / Q000517:prevention & control*; D015397:Program Evaluation; D016037:Single-Blind Method