ObjectiveTo assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity.DesignCluster randomised controlled trial.SettingUK primary schools from the West Midlands.Participants200 schools were randomly selected from all state run primary schools within 35 miles of the study centre (n=980), oversampling those with high minority ethnic populations. These schools were randomly ordered and sequentially invited to participate. 144 eligible schools were approached to achieve the target recruitment of 54 schools. After baseline measurements 1467 year 1 pupils aged 5 and 6 years (control: 28 schools, 778 pupils) were randomised, using a blocked balancing algorithm. 53 schools remained in the trial and data on 1287 (87.7%) and 1169 (79.7%) pupils were available at first follow-up (15 month) and second follow-up (30 month), respectively.InterventionsThe 12 month intervention encouraged healthy eating and physical activity, including a daily additional 30 minute school time physical activity opportunity, a six week interactive skill based programme in conjunction with Aston Villa football club, signposting of local family physical activity opportunities through mail-outs every six months, and termly school led family workshops on healthy cooking skills.Main outcome measuresThe protocol defined primary outcomes, assessed blind to allocation, were between arm difference in body mass index (BMI) z score at 15 and 30 months. Secondary outcomes were further anthropometric, dietary, physical activity, and psychological measurements, and difference in BMI z score at 39 months in a subset.ResultsData for primary outcome analyses were: baseline, 54 schools: 1392 pupils (732 controls); first follow-up (15 months post-baseline), 53 schools: 1249 pupils (675 controls); second follow-up (30 months post-baseline), 53 schools: 1145 pupils (621 controls). The mean BMI z score was non-significantly lower in the intervention arm compared with the control arm at 15 months (mean difference −0.075 (95% confidence interval −0.183 to 0.033, P=0.18) in the baseline adjusted models. At 30 months the mean difference was −0.027 (−0.137 to 0.083, P=0.63). There was no statistically significant difference between groups for other anthropometric, dietary, physical activity, or psychological measurements (including assessment of harm).ConclusionsThe primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity. Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments.Trial registrationCurrent Controlled Trials ISRCTN97000586.

Schools are increasingly recognized as an ideal setting for interventions to tackle childhood obesity. A better understanding of the views of key stakeholders would help to engage schools and inform the feasibility of such interventions in practice. This meta-synthesis of 18 qualitative studies explores the views of parents, school staff, school governors, school nurses and students on the role of the primary school in preventing childhood obesity. Six categories emerged: 'School as a key setting'; 'What schools should be doing to promote healthy eating (HE)'; 'What schools should be doing to promote physical activity (PA)'; 'General barriers'; 'Barriers to promoting HE at school'; and 'Barriers to promoting PA at school'. Thirty-seven finer-level themes emerged within these categories. Stakeholders agreed on the key role of the primary school as a setting for obesity prevention, the importance of schools providing and promoting opportunities for HE and PA, and the need for schools to work with parents. Some perceived barriers could be overcome at school level, e.g. using unhealthy foods as rewards/fundraisers or withholding PA for bad behaviour. Leadership and guidance from government were considered to be needed to counteract other observed barriers, particularly regarding school canteens, support for parents and time for PA.

ObjectivesIn spring 2020, the first COVID-19 national lockdown placed unprecedented restrictions on the behaviour and movements of the UK population. Citizens were ordered to ‘stay at home’, only allowed to leave their houses to buy essential supplies, attend medical appointments or exercise once a day. We explored how lockdown and its subsequent easing changed young children’s everyday activities, eating and sleep habits to gain insight into the impact for health and well-being.DesignIn-depth qualitative interviews; data analysed using thematic analysis.SettingSouth West and West Midlands of England.ParticipantsTwenty parents (16 mothers; 4 fathers) of preschool-age children (3–5 years) due to start school in September 2020. Forty per cent of the sample were from Black, Asian or minority ethnic backgrounds and half lived in the most deprived areas.ResultsChildren’s activity, screen time, eating and sleep routines had been disrupted. Parents reported children ate more snacks, but families also spent more time preparing meals and eating together. Most parents reported a reduction in their children’s physical activity and an increase in screen time, which some linked to difficulties in getting their child to sleep. Parents sometimes expressed guilt about changes in activity, screen time and snacking over lockdown. Most felt these changes would be temporary, though others worried about re-establishing healthy routines.ConclusionsParents reported that lockdown negatively impacted on preschool children’s eating, activity and sleep routines. While some positive changes were identified, many participants described lack of routines, habits and boundaries which may have been detrimental for child health and development. Guidance and support for families during COVID-19 restrictions could be valuable to help maintain healthy activity, eating, screen time and sleeping routines to protect child health and ensure unhealthy habits are not adopted.

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 8. See the NIHR Journals Library website for further project information.

Background and objectives Fluid overload and intradialytic hypotension are associated with cardiovascular events and mortality in patients on hemodialysis. We investigated associations between hemodialysis facility practices related to fluid volume and intradialytic hypotension and patient outcomes. Design, setting, participants, & measurements Data were analyzed from 10,250 patients in 273 facilities across 12 countries, from phase 4 of the Dialysis Outcomes and Practice Patterns Study (DOPPS; 2009-2012). Cox regression models (shared frailty) were used to estimate associations between facility practices reported by medical directors in response to the DOPPS Medical Directors Survey and all-cause and cardiovascular mortality and hospitalization, and cardiovascular events, adjusting for country, age, sex, dialysis vintage, predialysis systolic BP, cardiovascular comorbidities, diabetes, body mass index, smoking, residual kidney function, dialysis adequacy, and vascular access type. Results Of ten facility practices tested (chosen a priori), having a protocol that specifies how often to assess dry weight in most patients was associated with lower all-cause (hazard ratio [HR], 0.78; 99% confidence interval [99% CI], 0.64 to 0.94) and cardiovascular mortality (HR, 0.72; 99% CI, 0.55 to 0.95). Routine orthostatic BP measurement to assess dry weight was associated with lower all-cause hospitalization (HR, 0.86; 99% CI, 0.77 to 0.97) and cardiovascular events (HR, 0.85; 99% CI, 0.73 to 0.98). Routine use of lower dialysate temperature to limit or prevent intradialytic hypotension was associated with lower cardiovascular mortality (HR, 0.76; 99% CI, 0.58 to 0.98). Routine use of an online volume indicator to assess dry weight was associated with higher all-cause hospitalization (HR, 1.19; 99% CI, 1.02 to 1.38). Routine use of sodium modeling/profiling to limit or prevent intradialytic hypotension was associated with higher all-cause mortality (

BackgroundSchools are key settings for childhood obesity prevention, and the location for many intervention studies. This qualitative study aims to explore parent and child experiences of the WAVES study obesity prevention intervention, in order to gain understanding of the mechanisms by which the intervention results in behaviour change, and provide context to support interpretation of the main trial results.MethodsFocus groups were held with 30 parents and 62 children (aged 6-7 years) from primary schools in the West Midlands, UK. Data analysis (conducted using NVivo 10) was guided by the Framework Approach.ResultsThree over-arching themes were identified: ‘Impact’, ‘Sustainability’ and ‘Responsibilities’, under which sub-themes were determined. Participants were supportive of the school-based intervention. Parental involvement and the influential role of the teacher were seen as key ingredients for success in promoting consistent messages and empowering some parents to make positive behavioural changes at home. Parents recognised that whilst they held the primary responsibility for obesity prevention in their children, they faced a number of barriers to healthier lifestyles, and agreed that schools have an important role to play.ConclusionsThis study enabled us to better understand aspects of the WAVES study intervention programme that have the potential to initiate positive behaviour changes in families, and indicated that a combination of pathways influenced such changes. Pathways included: increasing capability through improving knowledge and skills of children and parents; increasing motivation through parental empowerment and role modelling; and the direct provision of opportunities to lead healthier lifestyles. Strategies to sustain behaviour changes, and the school role in supporting these, are important considerations.

BackgroundThe implementation of a complex intervention is heavily influenced by individual context. Variation in implementation and tailoring of the intervention to the particular context will occur, even in a trial setting. It is recognised that in trials, evaluating the process of implementation of a complex intervention is important, yet process evaluation methods are rarely reported. The WAVES study is a cluster randomised controlled trial to evaluate the effectiveness of an obesity prevention intervention programme targeting children aged 6–7 years, delivered by teachers in primary schools across the West Midlands, UK. The intervention promoted activities encouraging physical activity and healthy eating. This paper presents the methods used to assess implementation of the intervention.MethodsPrevious literature was used to identify the dimensions of intervention process and implementation to be assessed, including adherence, exposure, quality of delivery, participant responsiveness, context, and programme differentiation.ResultsMultiple methods and tools were developed to capture information on all these dimensions. These included observations, logbooks, qualitative evaluation, questionnaires and research team reflection.DiscussionData collection posed several challenges, predominantly when relying on teachers to complete paperwork, which they saw as burdensome on top of their teaching responsibilities. However, the use of multiple methods helped to ensure data on each dimension, where possible, was collected using more than one method. This also allowed for triangulation of the findings when several data sources on any one dimension were available.ConclusionsWe have reported a comprehensive approach to the assessment of the implementation and processes of a complex childhood obesity prevention intervention within a cluster randomised controlled trial. These approaches can be transferred and adapted for use in other complex intervention trials.Trial registration numberISRCTN97000586

Objective Oral anticoagulant (OAC) prescription for stroke prevention in atrial fibrillation (AF) patients frequently does not follow current guidelines, with underuse in patients at high risk of stroke and substantial overuse in those at low risk. This review aims to systematically evaluate the effectiveness of interventions to improve appropriate OAC prescription in eligible AF patients for stroke prevention. Methods Systematic review of controlled and uncontrolled studies published up to July 2017 with interventions designed to improve appropriate OAC prescription for stroke prevention in eligible AF patients (according to risk assessment tool or guidelines). Categorization of intervention types was pre-specified. The main outcome was change in proportion of eligible AF patients prescribed OACs for stroke prevention. Results Twenty studies conducted in 392 settings were included (cluster randomized controlled trials, controlled trials and uncontrolled before-after designs; n = 29,868 patients at baseline). Fifteen studies reported significant improvements in appropriate prescription of OACs in AF patients. All interventions with a persuasive element (8/8); all studies targeting health care professional (HCP) education or guideline/protocol implementation (7/7); and all medical care programs (4/4) achieved significant increases in appropriate OAC prescription. Computerized decision support interventions (3/5) and reviews of prescribing (2/4) were less likely to report significant improvements in appropriate OAC prescription. Conclusion Interventions designed to improve appropriate prescription of OACs in eligible AF patients for stroke prevention can be effective. Successful approaches include education of HCPs; implementation of local guidelines; interdisciplinary medical care programs educating both HCPs and patients and persuasive interventions utilizing peer-group experts. Protocol registration: PROSPERO (CRD42016039654).