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00925njm 22002777a 4500 dc Sanchez-Gomez, Luis Maria author Fernández-Luque, María Jesús author Ruiz-Díaz, Lourdes author Sánchez-Alcalde, Rosa author Sierra-García, Belén author Mayayo-Vicente, Soledad author Ruiz-López, Marta author Loeches-Belinchón, Pilar author López-Gónzález, Javier author González-Gamarra, Amelia author Gallego-Arenas, Ángela author Cubillo-Serna, Ana author Gil-Juberias, Gema author Pérez-Cayuela, Pilar author Cañedo-Arguelles, Celina Arana author García-Pascual, Julia Natividad author Ruiz Chércoles, Esther author Suárez-Fernández, Carmen author García-Polo, Iluminada author Abad-Perez, Daniel author Ballesteros-Arribas, Juan M author Izquierdo Martinez, Maravillas author Salvador-Alcaide, Elena author Arribas-Vela, Ana B author Alonso-Pérez, Juan M author Veja-Piris, Lorena author Rodríguez-Salvanés, Francisco author Novella-Arribas, Blanca author 2012-11-23 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. BMC Public Health. 2012 Nov 23;12:1024. 10.1186/1471-2458-12-1024 1471-2458 1471-2458 BMC public health 23176593 http://hdl.handle.net/20.500.12105/8747 A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project