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Supplementary Material 1

Additional file 1.

Additional file 2.

Additional file 1: Appendix 1. UCAT Post-test Questionnaire. Appendix 2. Questionnaire Responses. Appendix 3. Subsection score regression models with demographic variables as covariates. Appendix 4. SJT Band 4 binary logistic regression models with demographic variables as covariates. Appendix 5. Subsection score regression models with demographic variables and preparedness categories as covariates.

Background: Childhood obesity prevalence continues to be at high levels in the United Kingdom (UK). South Asian children (mainly Pakistani and Bangladeshi origin) with excess adiposity are at particular risk from the cardiovascular consequences of obesity. Many community-based children’s weight management programmes have been delivered in the UK, but none have been adapted for diverse cultural communities. The aim of the Child weigHt mANaGement for Ethnically diverse communities (CHANGE) study, was to culturally adapt an existing children’s weight management programme for children aged 4–11 years so that the programme was more able to meet the needs of families from South Asian communities. Methods: The adaptation process was applied to First Steps, an evidence informed programme being delivered in Birmingham (a large, ethnically diverse city). A qualitative study was undertaken to obtain the views of South Asian parents of children with excess weight, who had fully or partially attended, or who had initially agreed but then declined to attend the First Steps programme. The resulting data were integrated with current research evidence and local programme information as part of a cultural adaptation process that was guided by two theoretical frameworks. Results: Interviews or focus groups with 31 parents in their preferred languages were undertaken. Themes arising from the data included the need for convenient timing of a programme in a close familiar location, support for those who do not speak English, the need to focus on health rather than weight, nutritional content that focuses on traditional and Western diets, more physical activity content, and support with parenting skills. The data were mapped to the Behaviour Change Wheel framework and Typology of Cultural Adaptation to develop an intervention programme outline. The research evidence and local programme information was then used in the detailed planning of the programme sessions. Conclusions: The process of cultural adaptation of an existing children’s weight management programme resulted in a theoretically underpinned programme that is culturally adapted at both the surface and deep structural levels. Trial registration: ISRCTN81798055, registered: 13/05/2014.

Patients with primary biliary cholangitis (PBC) can be stratified into low-risk and high-risk groups based on their response to treatment. Newly published guidelines from the British Society of Gastroenterology suggest low-risk patients can be managed substantially in primary care. This represents a shift from existing practice and makes assumptions about service capacity and the willingness of both patients and health care practitioners (HCPs) to make this change. The aim of this paper is to identify possible barriers to the implementation of these new care pathways through review of the PBC-specific literature and by identifying the experiences of patients and HCPs managing a different condition with comparable patients and disease characteristics. Searches of MEDLINE, CINAHL and EMBASE were undertaken. Within the existing PBC literature there is little data surrounding stakeholder perspectives on place of care. Review of the breast cancer literature highlights a number of barriers to change including primary care practitioner knowledge and work load, communication between healthcare settings, and the significance of the established doctor-patient relationship. Further research is needed to establish the extent to which these barriers may surface when changing PBC care pathways, and the actions required to overcome them.

The CHANGE study adapted childrenâ s weight management intervention: Template for Intervention Description and Replication (TIDieR) checklist. (DOCX 18 kb)

CHANGE study: an example of the intervention adaptation process. (DOCX 14 kb)

The CHANGE study adapted childrenâ s weight management programme: Template for Intervention Description and Replication (TIDieR) checklist. (DOCX 23â kb)

Excess weight in children is associated with health, emotional and social problems. Schools offer an opportunity to promote healthy lifestyles. This study tested whether or not a programme of activities could prevent excess weight gain in primary school children. Fifty-four schools in the West Midlands participated, with 1397 year 1 pupils (aged 5–6 years) being involved in study measurements. The WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study healthy lifestyle programme was delivered over the next school year to children in 26 of the schools. The 1-year programme included: - helping teachers to provide opportunities for an additional 30 minutes of physical activity (PA) in the school day - participation in the ‘Villa Vitality’ programme (interactive learning led by Aston Villa Football Club with practical opportunities for PA and healthy eating) - termly healthy cooking skills and education workshops for parents and children - information to families signposting local PA opportunities. The remaining 28 schools continued with their usual activities. We assessed height, weight and other measures of body fat in all participating children. We also measured the children’s diet, PA levels and well-being. We took these measures before programme delivery, and again 3, 18 and 27 months after the end of the programme. Overall, we found no major difference in any measurements between children in schools with and children in schools without the WAVES study programme. The programme was not cost-effective. However, there were no safety concerns, the programme was well received by schools and families and it was perceived to have wider benefits.

Data provision and mean/median for each outcome measure at each time point. (DOCX 16â kb)

The CHANGE study comparator childrenâ s weight management programme: Template for Intervention Description and Replication (TIDieR) checklist). (DOCX 25â kb)

Background: Increasing prevalence of childhood obesity and its related consequences emphasises the importance of developing and evaluating interventions aimed at prevention. The importance of process evaluation in health intervention research is increasingly recognised, assessing implementation and participant response, and how these may relate to intervention success or failure. A comprehensive process evaluation was designed and undertaken for the West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study that tested the effectiveness of an obesity prevention programme for children aged 6-7 years, delivered in 24 UK schools. The four intervention components were: additional daily school-time physical activity (PA); cooking workshops for children and parents; Villa Vitality (VV), a 6-week healthy lifestyle promotion programme run by a local football club; and signposting to local PA opportunities. Methods: Data relating to six dimensions (Fidelity, Reach, Recruitment, Quality, Participant Responsiveness, Context) were collected via questionnaires, logbooks, direct observations, focus groups and interviews. Multiple data collection methods allowed for data triangulation and validation of methods, comparing research observations with teacher records. The 6-stage WAVES study model ((i) Data collection, (ii) Collation, (iii) Tabulation, (iv) Score allocation and discussion, (v) Consultation, (vi) Final score allocation) was developed to guide the collection, assimilation and analysis of process evaluation data. Two researchers independently allocated school scores on a 5-point Likert scale for each process evaluation dimension. Researchers then discussed school score allocations and reached a consensus. Schools were ranked by total score, and grouped to reflect low, medium or high intervention implementation. Results: The intervention was predominantly well-implemented and well-received by teachers, parents and children. The PA component was identified as the most challenging, VV the least. Median implementation score across schools was 56/75 (IQR, 51.0 - 60.8). Agreement between teacher logbooks and researcher observations was generally high, the main discrepancies occurred in session duration reporting where in some cases teachers’ estimations tended to be higher than researchers’. Conclusions: The WAVES study model provides a rigorous and replicable approach to undertaking and analysing a multicomponent process evaluation. Challenges to implementing school-based obesity prevention interventions have been identified which can be used to inform future trials.

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).