There is good evidence that various whole-school health interventions are effective in preventing teenage pregnancy, smoking, and bullying.

BackgroundRandomised controlled trials (RCTs) of social interventions are often criticised as failing to open the ‘black box’ whereby they only address questions about ‘what works’ without explaining the underlying processes of implementation and mechanisms of action, and how these vary by contextual characteristics of person and place. Realist RCTs are proposed as an approach to evaluation science that addresses these gaps while preserving the strengths of RCTs in providing evidence with strong internal validity in estimating effects.MethodsIn the context of growing interest in designing and conducting realist trials, there is an urgent need to offer a worked example to provide guidance on how such an approach might be practically taken forward. The aim of this paper is to outline a three-staged theoretical and methodological process of undertaking a realist RCT using the example of the evaluation of a whole-school restorative intervention aiming to reduce aggression and bullying in English secondary schools.DiscussionFirst, informed by the findings of our initial pilot trial and sociological theory, we elaborate our theory of change and specific a priori hypotheses about how intervention mechanisms interact with context to produce outcomes. Second, we describe how we will use emerging findings from the integral process evaluation within the RCT to refine, and add to, these a priori hypotheses before the collection of quantitative, follow-up data. Third, we will test our hypotheses using a combination of process and outcome data via quantitative analyses of effect mediation (examining mechanisms) and moderation (examining contextual contingencies). The results are then used to refine and further develop the theory of change.ConclusionThe aim of the realist RCT approach is thus not merely to assess whether the intervention is effective or not, but to develop empirically informed mid-range theory through a three-stage process. There are important implications for those involved with reporting and reviewing RCTs, including the use of new, iterative protocols.Trial registrationCurrent Controlled Trials ISRCTN10751359 (Registered 11 March 2014)

The prevalence of obesity appears to be declining in 4-year-old children in New Zealand across all socio-economic and ethnic groups.

BackgroundBullying and cyberbullying are common phenomena in schools. These negative behaviours can have a significant impact on the health and particularly mental health of those involved in such behaviours, both as victims and as bullies. This UK study aims to investigate student-level and school-level characteristics of those who become involved in bullying and cyberbullying behaviours as victims or perpetrators.MethodsWe used data from 6667 Year 7 students from the baseline survey of a cluster randomized trial in 40 English schools to investigate the associations between individual-level and school-level variables with bullying victimization, cyberbullying perpetration, and cyberbullying victimization. We ran multilevel models to examine associations of bullying outcomes with individual-level variables and school-level variables.ResultsIn multilevel models, at the school level, school type and school quality measures were associated with bullying risk: students in voluntary-aided schools were less likely to report bullying victimization (0.6 (0.4, 0.9) p = 0.008), and those in community (3.9 (1.5, 10.5) p = 0.007) and foundation (4.0 (1.6, 9.9) p = 0.003) schools were more likely to report being perpetrators of cyberbullying than students in mainstream academies. A school quality rating of “Good” was associated with greater reported bullying victimization (1.3 (1.02, 1.5) p = 0.03) compared to ratings of “Outstanding.”ConclusionsBullying victimization and cyberbullying prevalence vary across school type and school quality, supporting the hypothesis that organisational/management factors within the school may have an impact on students’ behaviour. These findings will inform future longitudinal research investigating which school factors and processes promote or prevent bullying and cyberbullying behaviours.Trial registrationTrial ID: ISRCTN10751359 Registered: 11/03/2014 (retrospectively registered).

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IMPORTANCE Although antibiotics are associated with obesity in animal models, the evidence in humans is conflicting. OBJECTIVE To assess whether antibiotic exposure during pregnancy and/or early childhood is associated with the development of childhood obesity, focusing particularly on siblings and twins. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional national study included 284 211 participants (132 852 mothers and 151 359 children) in New Zealand. Data analyses were performed for 150 699 children for whom data were available, 30 696 siblings, and 4188 twins using covariateadjusted analyses, and for 6249 siblings and 522 twins with discordant outcomes using fixedeffects analyses. Data analysis was performed November 2017 to March 2019. EXPOSURE Exposure to antibiotics during pregnancy and/or early childhood. MAIN OUTCOMES AND MEASURES The main outcome is odds of obesity at age 4 years. Anthropometric data from children born between July 2008 and June 2011 were obtained from the B4 School Check, a national health screening program that records the height and weight of 4-year-old children in New Zealand. These data were linked to antibiotics (pharmaceutical records) dispensed to women before conception and during all 3 trimesters of pregnancy and to their children from birth until age 2 years. RESULTS The overall study population consisted of 132 852 mothers and 151 359 children (77 610 [51.3%] boys) who were aged 4 to 5 years when their anthropometrical measurements were assessed. Antibiotic exposure was common, with at least 1 course dispensed to 35.7% of mothers during pregnancy and 82.3% of children during the first 2 years of life. Results from covariateadjusted analyses showed that both prenatal and early childhood exposures to antibiotics were independently associated with obesity at age 4 years, in a dose-dependent manner. Every additional course of antibiotics dispensed to the mothers yielded an adjusted odds ratio (aOR) of obesity in their children (siblings) of 1.02 (95% CI, 0.99-1.06), which was similar to the odds across pregnancy for the whole population (aOR, 1.06; 95% CI, 1.04-1.07). For the child's exposure, the aOR for the association between antibiotic exposure and obesity was 1.04 (95% CI, 1.03-1.05) among siblings and 1.05 (95% CI, 1.02-1.09) among twins. However, fixed-effects analyses of siblings and twins showed no associations between antibiotic exposure and obesity, with aORs of 0.95 (95% CI, 0.90-1.00) for maternal exposure, 1.02 (95% CI, 0.99-1.04) for child's exposure, and 0.91 (95% CI, 0.81-1.02) for twins' exposure. CONCLUSIONS AND RELEVANCE Although covariate-adjusted analyses demonstrated an association between antibiotic exposure and odds of obesity, further analyses of siblings and twins (continued) Key Points Question Is antibiotic exposure during pregnancy and/or during early childhood associated with the development of childhood obesity? Findings This cross-sectional national study of 284 211 participants (132 852 mothers and 151 359 children) in New Zealand found that...

Socioeconomic gradients in dental caries experience are evident by age 4 years, and these gradients vary by ethnicity and domain of deprivation.

BackgroundCluster randomised controlled trials (CRCTs) are increasingly used to evaluate the effectiveness of interventions for improving health. A key feature of CRCTs is that individuals in clusters are often more alike than individuals in different clusters, irrespective of treatment. This similarity within clusters needs to be taken into account when planning CRCTs to obtain adequate sample sizes, and when analysing clustered data to obtain correct estimates.MethodsNationally representative data from 15 to 16 year olds were analysed, from 21 of the 35 countries that participated in the 2007 European School Survey Project on Alcohol and Other Drugs. Within country school level intra-class correlation coefficients (ICCs) were calculated for substance use (self-reported alcohol use, regular alcohol use, binge drinking, any smoking, regular smoking, and illicit drug use) and psychosocial health (depressive mood and self-esteem). Unadjusted and adjusted ICCs are presented. ICCs are adjusted for student sex and socioeconomic status.ResultsICCs ranged from 0.01 to 0.21, with the highest (0.21) reported for regular smoking. Within country school level ICCs varied substantially across health outcomes, and among countries for the same health outcomes. Estimated ICCs were consistently higher for substance use (range 0.01–0.21), than for psychosocial health (range 0.01–0.07). Within country ICCs for health outcomes varied by changes in the measurement of particular health outcomes, for example the ICCs for regular smoking (range 0.06–0.21) were higher than those for having smoked at all in the last month (range 0.03–0.17).ConclusionsFor school level ICCs to be effectively utilised in informing sample size requirements for CRCTs and adjusting estimates from meta-analyses, the school level ICCs need to be both country and outcome specific.