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Background: The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation., Methods: Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics., Results: All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners., Conclusion: Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made., Trial Registration: ISRCTN15811706.

Schools are common sites for obesity prevention interventions. Although many theories suggest that the school context influences weight status, there has been little empirical research. The objective of this study was to explore whether features of the school context were consistently and meaningfully associated with pupil weight status (overweight or obese). Exploratory factor analysis of routinely collected data on 319 primary schools in Devon, England, was used to identify possible school-based contextual factors. Repeated cross-sectional multilevel analysis of five years (2006/07-2010/11) of data from the National Child Measurement Programme was then used to test for consistent and meaningful associations. Four school-based contextual factors were derived which ranked schools according to deprivation, location, resource and prioritisation of physical activity. None of which were meaningfully and consistently associated with pupil weight status, across the five years. The lack of consistent associations between the factors and pupil weight status suggests that the school context is not inherently obesogenic. In contrast, incorporating findings from education research indicates that schools may be equalising weight status, and obesity prevention research, policy and practice might need to address what is happening outside schools and particularly during the school holidays.

The workplace is an important setting for promoting health and well-being. We sought to understand how successful workplace health and well-being programs were developed and implemented to inform the development of a program for a National Health Service (NHS) hospital. Case studies of successful healthy workplace programs with 34 semi-structured employee interviews informed 12 interviews with NHS staff. Interviews were thematically analyzed using Nvivo. Themes were fed back to participants for further clarification and validation. Healthy workplace programs were characterized by senior management endorsement; collective sense of ownership; presence of visible "quick wins"; and a sense that participation was easy and fun, not mandated. Programs evolved organically, allowing trust to be built and activities to be developed with employees. Interviews with NHS staff suggested a lack of belief in the possibility of change in their workplace due to time and workload pressures, and a sense of an "us and them" relationship with management, as well as environmental barriers. A consistent pattern of how the conditions for a healthy workplace can be created, which map onto the results from the NHS ward staff, suggest that without creating an enabling environment for health-promoting behaviors, workplace programs will have poor uptake and retention.

Background: Approximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required. However, despite the increasing number of school-based interventions to prevent obesity, results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status. The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours., Methods: A process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of; the trial design (including the trial outcomes) and the HeLP Programme and whether it is able to engage schools, children and their families. Data was collected using interviews with teachers (n = 12) and parents (n = 17) and six focus groups with children (n = 47) and a questionnaire for parents of children in the intervention schools. Interview and focus group data relating to the intervention was analysed using framework analysis., Results: Four schools and 201 children participated in the exploratory trial. The data showed that the trial design was feasible and acceptable for schools and children. Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme (value, compatibility with the curriculum and enjoyment) and two themes emerged in relation to engagement ('knowledge and awareness' and 'taking messages on board'). The latter could be broken down into 4 subthemes ('initiating discussion with family and friends', 'acceptance of family rules', 'increased responsibility' and 'the importance of the mode and agent of delivery'). The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with and take ownership of the healthy lifestyle messages were identified as important factors in motivating the children to take the messages home, seek parental support and initiate family lifestyle behaviour change., Conclusion: The process evaluation of the exploratory trial has not only provided evidence of the feasibility and acceptability of the Programme, it has also allowed an understanding of how HeLP engages schools, children and their families. These findings have informed the process evaluation for the definitive trial.

Background: Over the last three decades there has been a substantial increase in the proportion of children who are overweight or obese. The Healthy Lifestyles Programme (HeLP) is a novel school-based intervention, using highly interactive and creative delivery methods to prevent obesity in children., Methods/design: We describe a cluster randomised controlled trial to evaluate the effectiveness and cost effectiveness of HeLP. The intervention has been developed using intervention mapping (involving extensive stakeholder involvement) and has been guided by the Information, Motivation, Behavioural Skills model. HeLP includes creating a receptive environment, drama activities, goal setting and reinforcement activities and runs over three school terms. Piloting showed that 9 to 10 year olds were the most receptive and participative. This study aims to recruit 1,300 children from 32 schools (over half of which will have ≥19% of pupils eligible for free school meals) from the southwest of England. Participating schools will be randomised to intervention or control groups with baseline measures taken prior to randomisation. The primary outcome is change in body mass index standard deviation score (BMI SDS) at 24 months post baseline. Secondary outcomes include, waist circumference and percent body fat SDS and proportion of children classified as overweight or obese at 18 and 24 months and objectively measured physical activity and food intake at 18 months. Between-group comparisons will be made using random effects regression analysis taking into account the hierarchical nature of the study design. An economic evaluation will estimate the incremental cost-effectiveness of HeLP, compared to control, from the perspective of the National Health Service (NHS)/third party payer. An in-depth process evaluation will provide insight into how HeLP works, and whether there is any differential uptake or engagement with the programme., Discussion: The results of the trial will provide evidence on the effectiveness and cost effectiveness of the Healthy Lifestyles Programme in affecting the weight status of children., Trial Registration: ISRCTN15811706.

Background: Only limited data are available on the development and feasibility piloting of school-based interventions to prevent and reduce obesity in children. Clear documentation of the rationale, process of development and content of such interventions is essential to enable other researchers to understand why interventions succeed or fail., Methods: This paper describes the development of the Healthy Lifestyles Programme (HeLP), a school-based intervention to prevent obesity in children, through the first 4 steps of the Intervention Mapping protocol (IM). The intervention focuses on the following health behaviours, i) reduction of the consumption of sweetened fizzy drinks, ii) increase in the proportion of healthy snacks consumed and iii) reduction of TV viewing and other screen-based activities, within the context of a wider attempt to improve diet and increase physical activity., Results: Two phases of pilot work demonstrated that the intervention was acceptable and feasible for schools, children and their families and suggested areas for further refinement. Feedback from the first pilot phase suggested that the 9-10 year olds were both receptive to the messages and more able and willing to translate them into possible behaviour changes than older or younger children and engaged their families to the greatest extent. Performance objectives were mapped onto 3 three broad domains of behaviour change objectives--establish motivation, take action and stay motivated--in order to create an intervention that supports and enables behaviour change. Activities include whole school assemblies, parents evenings, sport/dance workshops, classroom based education lessons, interactive drama workshops and goal setting and runs over three school terms., Conclusion: The Intervention Mapping protocol was a useful tool in developing a feasible, theory based intervention aimed at motivating children and their families to make small sustainable changes to their eating and activity behaviours. Although the process was time consuming, this systematic approach ensures that the behaviour change techniques and delivery methods link directly to the Programme's performance objectives and their associated determinants. This in turn provides a clear framework for process analysis and increases the potential of the intervention to realise the desired outcome of preventing and reducing obesity in children.