EdAl-2 (Educació en Alimentació) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children

Abstract

ObjectivesTo assess the reproducibility of an educational intervention EdAl-2 (Educació en Alimentació) programme in ‘Terres de l'Ebre’ (Spain), over 22 months, to improve lifestyles, including diet and physical activity (PA).DesignReproduction of a cluster randomised controlled trial.SettingTwo semi-rural town-group primary-school clusters were randomly assigned to the intervention or control group.ParticipantsPupils (n=690) of whom 320 constituted the intervention group (1 cluster) and 370 constituted the control group (1 cluster). Ethnicity was 78% Western European. The mean age (±SD) was 8.04±0.6 years (47.7% females) at baseline. Inclusion criteria for clusters were towns from the southern part of Catalonia having a minimum of 500 children aged 7–8 year; complete data for participants, including name, gender, date and place of birth, and written informed consent from parents or guardians.InterventionThe intervention focused on eight lifestyle topics covered in 12 activities (1 h/activity/session) implemented by health promoting agents in the primary school over three academic years.Primary and secondary outcomesThe primary outcome was obesity (OB) prevalence and the secondary outcomes were body mass index (BMI) collected every year and dietary habits and lifestyles collected by questionnaires filled in by parents at baseline and end-of-study.ResultsAt 22 months, the OB prevalence and BMI values were similar in intervention and control groups. Relative to children in control schools, the percentage of boys in the intervention group who performed ≥4 after-school PA h/week was 15% higher (p=0.027), whereas the percentage of girls in both groups remained similar. Also, 16.6% more boys in the intervention group watched ≤2 television (TV) h/day (p=0.009), compared to controls; and no changes were observed in girls in both groups.ConclusionsOur school-based intervention is feasible and reproducible by increasing after-school PA (to ≥4 h/week) in boys. Despite this improvement, there was no change in BMI and prevalence of OB.Trial registration number:Clinical Trials NCT01362023.

Effect of educational interventions on health in childhood

“…Study quality was evaluated using the Jadad scale, and the results are presented in Supplemental 1. Overall, 2 trials had a score of 5, [ 39 , 55 ] 7 trials had a score of 4, [ 29 , 32 , 43 , 46 , 50 , 52 , 54 ] 7 trials had a score of 3, [ 36 , 37 , 42 , 44 , 45 , 48 , 56 ] 6 trials had a score of 2, [ 30 , 33 , 41 , 51 , 53 , 57 ] 6 trials had a score of 1, [ 28 , 34 , 35 , 38 , 47 , 49 ] and the remaining 2 trials had a score of 0. [ 31 , 40 ]…”

The Effectiveness of School-Based Interventions on Obesity-Related Behaviours in Primary School Children: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

“…Four interventions did not measure BMI at any time point [72,77,81,82]. One study used a self-reported measurement for height and weight [103]; the remainder of the interventions measured the participants' body weight and height objectively by a member of the research team.…”

Intra-cluster correlations from the CLustered OUtcome Dataset bank to inform the design of longitudinal cluster trials

“…The CLOUD bank comprises 29 datasets and 44 continuous outcomes. Of these, 22 datasets were available for public access via online repositories, Dryad [23][24][25][26][27][28] , LSHTM data compass 29,30 , PLoS Medicine [31][32][33][34][35][36][37][38][39] and UK data service 40 . Seven datasets were included through permissions granted to co-authors 17,35,[41][42][43][44][45] .…”