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Objective: To propose an empirically derived and theoretically-informed mechanism to explain how Community Health Workers (CHWs) bring about health gain in clients in England., Methods: We undertook in-depth interviews (n = 43) with CHWs and service staff working in four case studies selected using maximum variation sampling. Interviewees were encouraged to talk about the service, how they had become involved with the service, the CHW role and relationship with clients., Findings: We identified the provision of social support to be central to the mechanism of CHW-mediated health gain. Appropriate social support provision comprised three inter-related elements; needs assessment, social support delivery and client engagement. This mechanism is dependent on the personal characteristics of CHWs and of the roles they are employed or volunteer to carry out., Conclusion: A range of CHW characteristics can influence the social support process, but these are context-dependent and move beyond simple notions of CHW similarity to the client. This finding has important policy implications for the development and implementation of CHW services in high income countries with super-diverse populations., (© The Author 2017. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Systematic reviews suggest that school-based interventions can be effective in preventing childhood obesity, but better-designed trials are needed that consider costs, process, equity, potential harms and longer-term outcomes., Objective: To assess the clinical effectiveness and cost-effectiveness of the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study intervention, compared with usual practice, in preventing obesity among primary school children., Design: A cluster randomised controlled trial, split across two groups, which were randomised using a blocked balancing algorithm. Schools/participants could not be blinded to trial arm. Measurement staff were blind to allocation arm as far as possible., Setting: Primary schools, West Midlands, UK., Participants: Schools within a 35-mile radius of the study centre and all year 1 pupils (aged 5-6 years) were eligible. Schools with a higher proportion of pupils from minority ethnic populations were oversampled to enable subgroup analyses., Interventions: The 12-month intervention encouraged healthy eating/physical activity (PA) by (1) helping teachers to provide 30 minutes of additional daily PA, (2) promoting 'Villa Vitality' (interactive healthy lifestyles learning, in an inspirational setting), (3) running school-based healthy cooking skills/education workshops for parents and children and (4) highlighting information to families with regard to local PA opportunities., Main Outcome Measures: The primary outcomes were the difference in body mass index z-scores (BMI-zs) between arms (adjusted for baseline body mass index) at 3 and 18 months post intervention (clinical outcome), and cost per quality-adjusted life-year (QALY) (cost-effectiveness outcome). The secondary outcomes were further anthropometric, dietary, PA and psychological measurements, and the difference in BMI-z between arms at 27 months post intervention in a subset of schools., Results: Two groups of schools were randomised: 27 in 2011 ( n  = 650 pupils) [group 1 (G1)] and another 27 in 2012 ( n  = 817 pupils) [group 2 (G2)]. Primary outcome data were available at first follow-up ( n  = 1249 pupils) and second follow-up ( n  = 1145 pupils) from 53 schools. The mean difference (MD) in BMI-z between the control and intervention arms was -0.075 [95% confidence interval (CI) -0.183 to 0.033] and -0.027 (95% CI -0.137 to 0.083) at 3 and 18 months post intervention, respectively. The main analyses showed no evidence of between-arm differences for any secondary outcomes. Third follow-up included data on 467 pupils from 27 G1 schools, and showed a statistically significant difference in BMI-z (MD -0.20, 95% CI -0.40 to -0.01). The mean cost of the intervention was £266.35 per consented child (£155.53 per child receiving the intervention). The incremental cost-effectiveness ratio associated with the base case was £46,083 per QALY (best case £26,804 per QALY), suggesting that the intervention was not cost-effective., Limitations: The presence of baseline primary outcome imbalance between the arms, and interschool variation in fidelity of intervention delivery., Conclusions: The primary analyses show no evidence of clinical effectiveness or cost-effectiveness of the WAVES study intervention. A post hoc analysis, driven by findings at third follow-up, suggests a possible intervention effect, which could have been attenuated by baseline imbalances. There was no evidence of an intervention effect on measures of diet or PA and no evidence of harm., Future Work: A realist evidence synthesis could provide insights into contextual factors and strategies for future interventions. School-based interventions need to be integrated within a wider societal framework and supported by upstream interventions., Trial Registration: Current Controlled Trials ISRCTN97000586., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 8. See the NIHR Journals Library website for further project information.

Background: Schools 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., Methods: Focus 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., Results: Three 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., Conclusions: This 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.

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 multi-ethnic 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., Trial Registration: Current Controlled Trials ISRCTN97000586 (registered May 2010).

Unlabelled: Policy Points: In 2004, England's National Health Service introduced health trainer services to help individuals adopt healthier lifestyles and to redress national health inequalities. Over time these anticipated community-focused services became more NHS-focused, delivering "downstream" lifestyle interventions. At the same time, individuals' lifestyle choices were abstracted from the wider social determinants of health and the potential to address inequalities was diminished. While different service models are needed to engage hard-to-reach populations, the long-term sustainability of any new service model depends on its aligning with the established medical system's characteristics., Context: In 2004, the English Public Health White Paper Choosing Health introduced "health trainers" as new members of the National Health Service (NHS) workforce. Health trainers would offer one-to-one peer-support to anyone who wished to adopt and maintain a healthier lifestyle. Choosing Health implicitly envisaged health trainers working in community settings in order to engage "hard-to-reach" individuals and other groups who often have the poorest health but who engage the least with traditional health promotion and other NHS services., Methods: During longitudinal case studies of 6 local health trainer services, we conducted in-depth interviews with key stakeholders and analyzed service activity data., Findings: Rather than an unproblematic and stable implementation of community-focused services according to the vision in Choosing Health, we observed substantial shifts in the case studies' configuration and delivery as the services embedded themselves in the local NHS systems. To explain these observations, we drew on a recently proposed conceptual framework to examine and understand the adoption and diffusion of innovations in health care systems., Conclusions: The health trainer services have become more "medicalized" over time, and in doing so, the original theory underpinning the program has been threatened. The paradox is that policymakers and practitioners recognize the need to have a different service model for traditional NHS services if they want hard-to-reach populations to engage in preventive actions as a first step to redress health inequalities. The long-term sustainability of any new service model, however, depends on its aligning with the established medical system's (ie, the NHS's) characteristics., (© 2014 Milbank Memorial Fund.)

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., Trial Registration Number: ISRCTN97000586.

The UK Coalition Government's Big Society policy has highlighted the value of the contribution that local people can make to well-being in their own communities, and plans to increase the contribution of community groups and third sector organizations in delivering services. This paper attempts to unpick some of the challenges to delivering health improvement interventions within the Big Society framework, and offers suggestions to reduce risk and preserve the value of the unique contribution that local people can make. The challenges identified are: supporting and developing skills in social enterprise; demonstrating effectiveness to commissioners; supporting local enterprise while mindful of inequality; guarding against the third sector losing its dynamism; using volunteers to replace or complement existing services. We conclude that the drive to increase community sustainability through the involvement of individuals is laudable, and responds to potential flaws in the welfare state. In order to protect the most vulnerable, and ensure equity, any change will take time and resources. More efficient ways of meeting society's needs must be sought, but we recommend that a stepwise, supported and appropriately evaluated approach is essential, and equity of provision across communities and organizations must be a primary concern.

Objectives To develop an empirically-informed reporting taxonomy for Community Health Worker (CHW) services to address concerns about the transparency and consistency of descriptions of these interventions in the existing literature Methods We undertook in-depth interviews (n = 43) with CHWs and service staff working in four case studies selected using maximum variation sampling. Interviewees were encouraged to talk about the service, how they had become involved with the service, the CHW role and relationship with clients. Results Thematic analysis identified recurrent cross-case observations which we classed as 'who CHW are' and 'what CHW do'. CHW's personal characteristics comprised the sub-groups knowledge and skills, personal qualities, similarity to client and voluntary/paid status; role characteristics comprised time and continuity, settings, limited responsibility, core task and enacted philosophies. Conclusions We have developed a conceptual framework for reporting CHW interventions based on the existing literature and our own empirical work. Compared with existing work in the field, the taxonomy uses nomenclature that minimizes current overlap and confusion, and provides a more complete description of CHW characteristics. [ABSTRACT FROM AUTHOR]

Background The Health Trainers Service is one of the few public health policies where a bespoke database--the Data Collection and Reporting System (DCRS)--was developed to monitor performance. We seek to understand the context within which local services and : DCRS and to consider how this might influence interpretation of collected data. Methods In-depth case studies of six local services purposively sampled to represent the range of service provider arrangements, detailed interviews with key stakeholders (n = 118). Results Capturing detailed information on activity with clients was alien to many health trainers' work practices. This related to technical challenges, but it also ran counter to beliefs as to how a 'lay' service would operate. Interviewees noted the inadequacy of the dataset to capture all client impacts; that is, it did not enable them to input information about issues a client living in a deprived neighbourhood might experience and seek help to address. Conclusions The utility of the DCRS may be compromised both by incomplete ascertainment of activity and by incorrect data inputted by some Health Trainers. The DCRS is also underestimate the effectiveness of work health trainers have undertaken to address 'upstream' factors affecting client health. [ABSTRACT FROM AUTHOR]

The challenge of measuring outcomes associated with area-based regeneration initiatives has been discussed extensively in the literature. Key issues relate to the availability of appropriate data and the need to have some indication of the counter-factual-that is, what would have happened in the absence of the initiative. In this paper, we offer an assessment of the utility of a method to construct virtual area models that can be used as 'controls' in the quasi-experimental evaluation of an urban regeneration initiative and comment on the availability of appropriate health outcome data to populate such models. [ABSTRACT FROM AUTHOR]