BackgroundThe World Health Organization's (WHO's) Health Promoting Schools (HPS) framework is an holistic, settings-based approach to promoting health and educational attainment in school. The effectiveness of this approach has not been previously rigorously reviewed. ObjectivesTo assess the effectiveness of the Health Promoting Schools (HPS) framework in improving the health and well-being of students and their academic achievement.

BackgroundHealthy children achieve better educational outcomes which, in turn, are associated with improved health later in life. The World Health Organization’s Health Promoting Schools (HPS) framework is a holistic approach to promoting health and educational attainment in school. The effectiveness of this approach has not yet been rigorously reviewed.MethodsWe searched 20 health, education and social science databases, and trials registries and relevant websites in 2011 and 2013.We included cluster randomised controlled trials. Participants were children and young people aged four to 18 years attending schools/colleges. HPS interventions had to include the following three elements: input into the curriculum; changes to the school’s ethos or environment; and engagement with families and/or local communities.Two reviewers identified relevant trials, extracted data and assessed risk of bias. We grouped studies according to the health topic(s) targeted. Where data permitted, we performed random-effects meta-analyses.ResultsWe identified 67 eligible trials tackling a range of health issues. Few studies included any academic/attendance outcomes. We found positive average intervention effects for: body mass index (BMI), physical activity, physical fitness, fruit and vegetable intake, tobacco use, and being bullied. Intervention effects were generally small. On average across studies, we found little evidence of effectiveness for zBMI (BMI, standardized for age and gender), and no evidence for fat intake, alcohol use, drug use, mental health, violence and bullying others. It was not possible to meta-analyse data on other health outcomes due to lack of data. Methodological limitations were identified including reliance on self-reported data, lack of long-term follow-up, and high attrition rates.ConclusionThis Cochrane review has found the WHO HPS framework is effective at improving some aspects of student health. The effects are small but potentially important at a population level.

The World Health Organization’s Health Promoting Schools (HPS) framework is a whole-school approach to promoting health that recognizes the intrinsic relationship between health and education. Our recent Cochrane systematic review found HPS interventions produced improvements in a number of student health outcomes. Here we reflect on what this review was not able to tell us: in other words, what evidence is missing with regard to the HPS approach. Few HPS interventions engage with schools’ “core business” by examining impacts on educational outcomes. Current evidence is dominated by obesity interventions, with most studies conducted with children rather than adolescents. Evidence is lacking for outcomes such as mental or sexual health, substance use, and violence. Activities to engage families and communities are currently weak and unlikely to prompt behavioral change. The HPS approach is largely absent in low-income settings, despite its potential in meeting children’s basic health needs. Intervention theories are insufficiently complex, often ignoring upstream determinants of health. Few studies provide evidence on intervention sustainability or cost-effectiveness, nor in-depth contextual or process data. We set out an agenda for future school health promotion research, considering implications for key stakeholders, namely, national governments, research funders, academics, and schools.

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Background: An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. Methods: A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Findings: Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

Background: Healthy children achieve better educational outcomes which, in turn, are associated with improved health later in life. The World Health Organization's Health Promoting Schools (HPS) framework is a holistic approach to promoting health and educational attainment in school. The effectiveness of this approach has not yet been rigorously reviewed.Methods: We searched 20 health, education and social science databases, and trials registries and relevant websites in 2011 and 2013. We included cluster randomised controlled trials. Participants were children and young people aged four to 18 years attending schools/colleges. HPS interventions had to include the following three elements: input into the curriculum; changes to the school's ethos or environment; and engagement with families and/or local communities. Two reviewers identified relevant trials, extracted data and assessed risk of bias. We grouped studies according to the health topic(s) targeted. Where data permitted, we performed random-effects meta-analyses. Results:We identified 67 eligible trials tackling a range of health issues. Few studies included any academic/ attendance outcomes. We found positive average intervention effects for: body mass index (BMI), physical activity, physical fitness, fruit and vegetable intake, tobacco use, and being bullied. Intervention effects were generally small. On average across studies, we found little evidence of effectiveness for zBMI (BMI, standardized for age and gender), and no evidence for fat intake, alcohol use, drug use, mental health, violence and bullying others. It was not possible to meta-analyse data on other health outcomes due to lack of data. Methodological limitations were identified including reliance on self-reported data, lack of long-term follow-up, and high attrition rates. Conclusion:This Cochrane review has found the WHO HPS framework is effective at improving some aspects of student health. The effects are small but potentially important at a population level.

Background: We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. Methods: A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Findings: 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome . Conclusions: Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

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