BackgroundThis 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/designThis 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.DiscussionThe intervention providing the best results could be recommended as part of health education for young schoolchildren.Trial registrationClinicaltrials.gov: NCT01418872

Background: A number of strategies exist for the implementation of clinical practice guides (CPGs). Aim: To assess the efficacy of implementing a cardiovascular risk CPG based on an educational method involving opinion leaders, and the habitual method of dissemination among primary healthcare teams. Design and Setting: Controlled, blinded, community intervention trial randomised by clusters. Methods: 21 primary healthcare centres were randomly assigned to either the intervention arm (n = 11) or the control arm (n = 10). The study subjects were patients aged ≥45 years assigned to the centres. The overall impact of the intervention was measured as the difference between the increase in the proportion of patients whose medical records showed the recording of all the variables necessary to calculate cardiovascular risk in both arms. Analyses were performed with Generalized Lineal Model on an intention-to-treat basis. Results: 917 subjects were included at the beginning of the trial (437 in the intervention arm and 480 in the control arm). 826 subjects were included in the final evaluation (436 in the intervention group and 390 in the control arm). At the end of the trial, the recording of the variables necessary for the calculation of the cardiovascular risk in the intervention group had increased more than in the control group