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Background: There is some evidence that school-based interventions are effective in preventing childhood obesity. However, longer term outcomes, equity of effects and cost-effectiveness of interventions have not been assessed. The aim of this trial is to assess the clinical and cost-effectiveness of a multi-component intervention programme targeting the school and family environment through primary schools, in preventing obesity in 6-7 year old children, compared to usual practice. Methods: This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including a multi-ethnic, socioeconomically diverse population of children aged 6-7 years. The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increase time spent doing physical activity within the school day, participation in the 'Villa Vitality' programme (a programme that is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learning opportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parents and children, and provision of information to families signposting local leisure opportunities. The primary (clinical) outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-intervention completion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 children split across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC ≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examined using mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust for pre-specified baseline school and child level covariates. Discussion: The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study is the first trial that will examine the cost-effectiveness and long term outcomes of a childhood obesity prevention programme in a multiethnic population, with a sufficient sample size to detect clinically important differences in adiposity. The intervention was developed using the Medical Research Council framework for complex interventions, and outcomes are measured objectively, together with a comprehensive process evaluation. [ABSTRACT FROM AUTHOR]

Background. The 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. Methods. Previous 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. Results. Multiple methods and tools were developed to capture information on all these dimensions. These included observations, logbooks, qualitative evaluation, questionnaires and research team reflection. Discussion. Data 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. Conclusions. We 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. [ABSTRACT FROM AUTHOR]

Background: If UK healthcare services are to respond effectively to pandemic influenza, levels of absenteeism amongst healthcare workers (HCWs) must be minimised. Current estimates of the likelihood that HCWs will continue to attend work during a pandemic are subject to scientific and predictive uncertainty, yet an informed evidence base is needed if contingency plans addressing the issues of HCW absenteeism are to be prepared. Methods: This paper reports the findings of a self-completed survey of randomly selected HCWs across three purposively sampled healthcare trusts in the West Midlands. The survey aimed to identify the factors positively or negatively associated with willingness to work during an influenza pandemic, and to evaluate the acceptability of potential interventions or changes to working practice to promote the continued presence at work of those otherwise unwilling or unable to attend. 'Likelihood' and 'persuadability' scores were calculated for each respondent according to indications of whether or not they were likely to work under different circumstances. Binary logistic regression was used to compute bivariate and multivariate odds ratios to evaluate the association of demographic variables and other respondent characteristics with the self-described likelihood of reporting to work. Results: The survey response rate was 34.4% (n = 1032). Results suggest absenteeism may be as high as 85% at any point during a pandemic, with potential absence particularly concentrated amongst nursing and ancillary workers (OR 0.3; 95% CI 0.1 to 0.7 and 0.5; 95% CI 0.2 to 0.9 respectively). Conclusion: Levels of absenteeism amongst HCWs may be considerably higher than official estimates, with potential absence concentrated amongst certain groups of employees. Although interventions designed to minimise absenteeism should target HCWs with a low stated likelihood of working, members of these groups may also be the least receptive to such interventions. Changes to working conditions which reduce barriers to the ability to work may not address barriers linked to willingness to work, and may fail to overcome HCWs' reluctance to work in the face of what may still be deemed unacceptable risk to self and/or family. [ABSTRACT FROM AUTHOR]

Background: Healthcare workers (HCWs) will play a key role in any response to pandemic influenza, and the UK healthcare system's ability to cope during an influenza pandemic will depend, to a large extent, on the number of HCWs who are able and willing to work through the crisis. UK emergency planning will be improved if planners have a better understanding of the reasons UK HCWs may have for their absenteeism, and what might motivate them to work during an influenza pandemic. This paper reports the results of a qualitative study that explored UK HCWs' views (n = 64) about working during an influenza pandemic, in order to identify factors that might influence their willingness and ability to work and to identify potential sources of any perceived duty on HCWs to work. Methods: A qualitative study, using focus groups (n = 9) and interviews (n = 5). Results: HCWs across a range of roles and grades tended to feel motivated by a sense of obligation to work through an influenza pandemic. A number of significant barriers that may prevent them from doing so were also identified. Perceived barriers to the ability to work included being ill oneself, transport difficulties, and childcare responsibilities. Perceived barriers to the willingness to work included: prioritising the wellbeing of family members; a lack of trust in, and goodwill towards, the NHS; a lack of information about the risks and what is expected of them during the crisis; fear of litigation; and the feeling that employers do not take the needs of staff seriously. Barriers to ability and barriers to willingness, however, are difficult to separate out. Conclusion: Although our participants tended to feel a general obligation to work during an influenza pandemic, there are barriers to working, which, if generalisable, may significantly reduce the NHS workforce during a pandemic. The barriers identified are both barriers to willingness and to ability. This suggests that pandemic planning needs to take into account the possibility that staff may be absent for reasons beyond those currently anticipated in UK planning documents. In particular, staff who are physically able to attend work may nonetheless be unwilling to do so. Although there are some barriers that cannot be mitigated by employers (such as illness, transport infrastructure etc.), there are a number of remedial steps that can be taken to lesson the impact of others (providing accommodation, building reciprocity, provision of information and guidance etc). We suggest that barriers to working lie along an ability/willingness continuum, and that absenteeism may be reduced by taking steps to prevent barriers to willingness becoming perceived barriers to ability. [ABSTRACT FROM AUTHOR]

Background: Healthcare workers (HCWs) will be key players in any response to pandemic influenza, and will be in the front line of exposure to infection. Responding effectively to a pandemic relies on the majority of medical, nursing, laboratory and hotel services staff continuing to work normally. Planning assumes that during a pandemic normal healthcare service levels will be provided, although it anticipates that as caseloads increase only essential care will be provided. The ability of the NHS to provide expected service levels is entirely dependent upon HCWs continuing to work as normal. Methods/design: This study is designed as a two-phase multi-method study, incorporating focus groups and a questionnaire survey. In phase one, qualitative methods will be used to collect the views of a purposive sample of HCWs, to determine the range of factors associated with their responses to the prospect of working through pandemic influenza. In phase two, the findings from the focus groups, combined with the available literature, will be used to inform the design of a survey to determine the generalisability of these factors, enabling the estimation of the likely proportion of HCWs affected by each factor, and how likely it is that they would be willing and/or able to continue to work during an influenza pandemic. Discussion: There are potentially greater than normal health risks for some healthcare workers working during a pandemic, and these workers may be concerned about infecting family members/ friends. HCWs will be as liable as other workers to care for sick family members and friends. It is vital to have information about how motivated HCWs will be to continue to work during such a crisis, and what factors might influence their decision to work/not to work. Through the identification and subsequent management of these factors it may be possible to implement strategies that will alleviate the concerns and fears of HCWs and remove potential barriers to working. [ABSTRACT FROM AUTHOR]

Background: Group-based children's weight management programmes are widely available in the UK and evidence shows that these are effective in the short-term. No programmes have been specifically developed to meet the cultural requirements of UK minority ethnic communities. South Asian children are a high-risk group for obesity and its consequences; therefore, the study aim is to adapt an existing weight management programme for children aged 4-11 years and their families to ensure cultural relevance to Pakistani and Bangladeshi communities, and undertake a feasibility study of the adapted programme., Methods/design: Pakistani and Bangladeshi families of overweight children who have been offered the existing children's weight management programme in Birmingham, UK, will be invited to interviews and focus groups to explore their experiences and views of the programme. These data, together with existing literature and service provider information, will inform adaptation of the programme to be more culturally relevant to these families. The feasibility study will employ a cluster-randomised design, and will assess success of programme adaptation and feasibility of programme delivery. Planned programmes will be randomised to be delivered as the adapted programme (intervention) or the standard programme (comparator) with a 2:1 ratio. The primary outcome will be the proportion of Pakistani and Bangladeshi families completing the adapted programme. To assess recruitment, retention and data collection methods to inform a future trial, we aim to recruit 80 participants. A range of assessments will be undertaken with participants pre-, post- and 6-months post-intervention., Discussion: This study addresses the identified need to provide children's weight management programmes that are suitable for minority ethnic communities. Whilst the focus of the intervention adaptation is on Pakistani and Bangladeshi communities, the programme will be developed to be flexibly delivered to meet the cultural needs of communities of all ethnic compositions. The feasibility study will directly compare the adapted and existing weight management programmes, and will enable a comprehensive evaluation of the success of the adaptation. Essential information will also be gathered to inform the design and sample size calculation of a future trial to evaluate intervention effectiveness., Trial Registration: ISRCTN81798055, registered: 13/05/2014.