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Abstract Background Many countries have introduced school food standards to improve the dietary intakes of school-aged children. England has school food standards (SFS) legislation in place but little is known about how well secondary schools comply with this. We aimed to assess compliance with the SFS legislation in English secondary schools and explore the impact of the SFS on pupils’ nutritional intake. Methods We conducted a cross-sectional study with English secondary schools from 2019 to 2022. We compared SFS compliance and pupil nutritional intake in schools mandated or not mandated to comply with the SFS legislation, and explored the association between school compliance and pupil nutritional intake. We assessed the percentage of SFS (%SFS) complied with by reviewing school food menus and observing food served in school canteens. We assessed pupil nutritional intake using a 24-hour dietary recall measure (Intake24) and estimated intakes of free sugar (primary outcome) and other nutrients/foods. We used adjusted multilevel models to compare pupil intakes in the SFS-mandated and SFS-non-mandated schools, and to explore the association between school SFS compliance and pupil intakes. Results 36 schools (23 not mandated and 13 mandated to comply with the SFS) and 2,273 pupils participated. The median %SFS complied with was 63.9% (interquartile range 60.0–70.0%). This was similar for SFS-non-mandated (64.5%) and SFS-mandated schools (63.3%). Compliance was highest for standards applying to lunchtime (median = 81.3%) and lowest for those applying across the whole school day (median = 41.7%). It was also lower for standards restricting high fat, sugar and energy-dense items (median = 26.1%) than for standards aiming to increase dietary variety (median = 92.3%). Pupils from SFS-mandated schools had a lower mean lunchtime intake of free sugar (g) (adjusted mean difference: -2.78g; 95% CI: -4.66g to -0.90g). There were few significant associations between %SFS complied with and pupil nutritional intake. Conclusions English secondary schools do not fully comply with SFS legislation regardless of whether they are mandated to comply. Schools and caterers may require monitoring and support to fully comply. There is little evidence that SFS compliance is associated with better pupil nutritional intake. Food environments outside of school also need to be considered. Study registration ISRCTN68757496 (17-10-2019).

Abstract Background Typical adolescent diets do not meet current dietary recommendations. There is a need to address these dietary patterns to reduce the risk of obesity and other diet-related diseases. Schools provide an opportune setting to do so, as students consume a substantial proportion of their daily dietary intake whilst at school. There is a developing evidence base on the use of choice architecture (food choice cues) to promote healthy eating in school contexts. It is necessary to understand the acceptability and feasibility of implementing such interventions. We aimed to explore these factors from the perspectives of secondary school caterers. Methods We conducted qualitative interviews with caterers from secondary schools across the West Midlands, UK and national/regional catering representatives. A semi-structured topic guide and visual aid were used to guide interviews. Interviews were recorded and transcribed. Framework analysis was conducted in NVivo v12. Results Twelve participants took part. Seven themes were identified and grouped into three categories: Acceptability (Suitability; Salient cues; Student engagement), Barriers (Catering decision drivers; Limits of influence), and Enablers (Perceived role; Opportunities). Caterers considered healthy food cues to be suited to adolescents as they require minimal reflective motivation. Salient cues included enhancing the placement, presentation and portability of healthy items, improving the dining environment and focusing pricing/incentive strategies on increased quantity. Student engagement was considered important. Some catering decision drivers conflicted with healthy food cues, and many felt that their role in healthy eating was limited due to the overwhelming influence of external food environments, adolescent resistance, and features of the secondary school canteen setting e.g. short duration of lunchtime, lack of space. However, caterers appeared motivated to implement healthy food cues and identified key opportunities for implementation, including integration into whole-school approaches to healthy eating. Conclusions Interventions using healthy food cues appeared acceptable to secondary school caterers, key potential implementers of these strategies. Future interventions could incorporate strategies relating to placement, presentation and pricing to prompt healthy selections, and actions to engage the student body and improve the dining environment. Evaluations should consider potential impacts upon food purchasing, consumption and waste to address caterers’ concerns about these issues.

Introduction: Pancytopenia in the peripheral smear and hypocellularity in the bone marrow characterise aplastic anaemia (AA). It is far less common in Western countries. The Asian continent has a greater prevalence rate. Aplastic anemia carries a high mortality rate if it is not treated. Hence early diagnosis and treatment is important to reduce the mortality rate. Only few Indian studies are conducted to assess the epidemiology of AA. Aims and Objectives: To evaluate clinical and pathological profile of patients with aplastic anemia. Materials and Methods: This cross sectional observational study was done over a period of 1.5years in department of medicine, St johns medical college, Bangalore. A detailed clinical history, physical examination and available previous investigations were recorded. Results: In our study aplastic anemia had bimodal peak in age distribution noted in groups of 21-30 & 51-60yrs .Male preponderance of 1.33:1 .Most common presenting complaint was Fatigue. Severe (37.6%) and Very severe aplastic anemia (37.6%) were more common.Most common 1st line agent was Cyclosporine and 2nd line agent was Danazol. Out the 35 only 4 (11.4%) showed Complete Response, 19 (54.3%) showed Partial Remission, 10 were transfusion dependent (28.6%) and 2 (5.8%) expired. Conclusion: ATG and Cyclosporine showed significant improvement in most parameters. Many patients in the study were unwilling for ATG and bone marrow transplantation due to the cost factor. Many are still requiring frequent transfusions, thus probing us to search for newer novel forms of treatment to reduce the cost of treatment and mortality in aplastic anemia patients.

Aim To identify characteristics associated with (1) having overweight, obesity and severe obesity at 11 years and (2) rapid weight gain (defined as increasing weight status by one or more body mass index (BMI) categories) between the ages of 4–5 and 10–11 years.Method Using National Child Measurement Programme data, BMI at reception (4–5 years) and year 6 (10–11 years) were linked for 15 390 children. Weight categories were identified at both time points using BMI centile classifications.For each child, the number of BMI categories they crossed between reception and year 6 was identified. Logistic regression models were fitted to explore associations with sociodemographic characteristics of children with excess weight at age 10–11 years and with children experiencing rapid weight gain between reception and year 6.Results Overall, 61.9% of children remained in their original weight category; 30% whose weight increased by ≥1 weight categories and 11.7% by ≥2 weight categories. Only 7.8% had decreased ≥1 weight categories and 0.9% had decreased ≥2 weight categories.Adjusting for other sociodemographic characteristics, girls were less likely than boys to increase ≥2 weight categories between reception and year 6 (OR 0.64; 95% CI 0.58 to 0.71; p

Abstract Background One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settings provide opportunities to deliver interventions to improve nutritional quality and physical activity to the majority of 3–4-year-olds. The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA with high acceptability in the UK. The study aims to evaluate the effectiveness and cost-effectiveness of the NAP SACC UK intervention to increase physical activity, reduce sedentary time and improve nutritional intake. Methods Multi-centre cluster RCT with process and economic evaluation. Participants are children aged 2 years or over, attending UK early years settings (nurseries) for ≥ 12 h/week or ≥ 15 h/week during term time and their parents, and staff at participating nurseries. The 12-month intervention involves nursery managers working with a Partner (public health practitioner) to self-assess policies and practices relating to physical activity and nutrition; nursery staff attending one physical activity and one nutrition training workshop and setting goals to be achieved within 6 months. The Partner provides support and reviews progress. Nursery staff receive a further workshop and new goals are set, with Partner support for a further 6 months. The comparator is usual practice. Up to 56 nurseries will be stratified by area and randomly allocated to intervention or comparator arm with minimisation of differences in level of deprivation. Primary outcomes: accelerometer-assessed mean total activity time on nursery days and average total energy (kcal) intake per eating occasion of lunch and morning/afternoon snacks consumed within nurseries. Secondary outcomes: accelerometer-assessed mean daily minutes of moderate-to-vigorous physical activity and sedentary time per nursery day, total physical activity on nursery days compared to non-nursery days, average serving size of lunch and morning/afternoon snacks in nursery per day, average percentage of core and non-core food in lunch and morning/afternoon snacks, zBMI, proportion of children who are overweight/obese and child quality-of-life. A process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will compare costs and consequences from the perspective of the local government, nursery and parents. Trial registration ISRCTN33134697, 31/10/2019.

Mental disorders are prevalent during adolescence. Self-harm and suicide are more common in adolescents with a probable mental disorder, with one in four reporting to have attempted self-harm. Research involving adolescents is, therefore, likely to include participants experiencing mental ill health, even if mental health is not the primary focus. Researchers should adopt procedures and principles that safeguard adolescent mental health in their research practice. Yet there are gaps between theory and practice of research with adolescents in relation to their mental health, and limited guidance is available.We discuss emerging safeguarding dilemmas and procedures in adolescent mental health research. Our experiences of safeguarding adolescent mental health are grounded in the UK National Institute for Health and Care Research-funded SMART Schools Study. Drawing from this secondary school-based study, we focus on how our research team encountered and addressed a high prevalence of participants (aged 12–13 and 14–15 years) reporting thoughts and behaviours related to self-harm or suicide (24% of participants). This included reviewing our existing risk mitigation processes and consulting with several committees including young people with lived experiences of mental health.We present the SMART Schools study safeguarding approach for adolescent mental health. This encompasses key safeguarding principles, study procedures and relevant justifications. We address school and university roles and responsibilities, pupil understanding, and efficient, effective and secure communication pathways. We embed guidance throughout this article for researchers working with adolescents in the context of mental health. Lastly, we present five key recommendations to safeguard the mental health of adolescents participating in research, including (1) appointing a safeguarding lead within the research team; (2) codesigning a bespoke study safeguarding approach; (3) adopting a responsive approach to mental health safeguarding; (4) being transparent about the study mental health safeguarding approach and (5) report the implementation and outcomes of safeguarding approaches.Trial registration number ISRCTN77948572.

Background and aims Bleeding from parastomal varices causes significant morbidity and mortality. Treatment options are limited, particularly in high-risk patients with significant underlying liver disease and other comorbidities. The use of EUS-guided embolisation coils combined with thrombin injection in gastric varices has been shown to be safe and effective. Our institution has applied the same technique to the treatment of parastomal varices.Methods A retrospective review was performed of 37 procedures on 24 patients to assess efficacy and safety of EUS-guided injection of thrombin, with or without embolisation coils for treatment of bleeding parastomal varices. All patients had been discussed in a multidisciplinary team meeting, and correction of portal hypertension was deemed to be contraindicated. Rebleeding was defined as stomal bleeding that required hospital admission or transfusion.Results All patients had significant parastomal bleeding at the time of referral. 100% technical success rate was achieved. 70.8% of patients had no further significant bleeding in the follow-up period (median 26.2 months) following one procedure. 1-year rebleed-free survival was 80.8% following first procedure. 7 patients (29.1%) had repeat procedures. There was no significant difference in rebleed-free survival following repeat procedures. Higher age was associated with higher risk of rebleeding. No major procedure-related complications were identified.Conclusions EUS-guided thrombin injection, with or without embolisation coils, is a safe and effective technique for the treatment of bleeding parastomal varices, particularly for patients for whom correction of portal venous hypertension is contraindicated.

Introduction Smartphone and social media use is prevalent during adolescence, with high levels of use associated with lower levels of mental well-being. Secondary schools in the UK have introduced policies that restrict daytime use of smartphones and social media, but there is no evaluation on the impact of these policies on adolescent mental well-being. The SMART Schools Study aims to determine the impact of daytime restrictions of smartphone and social media use on indicators of adolescent mental well-being, anxiety, depression, physical activity, sleep, classroom behaviour, attainment and addictive social media use.Methods and analysis This is a natural experimental observational study using mixed methods. Secondary schools within a 100 mile radius of the recruiting centre in the West Midlands (UK) have been categorised into two groups: Schools that restrict (intervention) and permit (comparator) daytime use of smartphones. We aim to recruit 30 schools (20 restrictive, 10 permissive) and 1170 pupils aged 12–13 and 14–15 years. We will collect data on mental well-being, anxiety and depressive symptoms, phone and social media use, sleep and physical activity from pupil surveys, and accelerometers. Policy implementation measures and data on individual pupil factors will be collected through school staff surveys, and website/policy analysis. Six case study schools will explore individual, school and family/home factors that influence relationships between school smartphone policies, smartphone/social media use, and mental well-being. Economic evaluation will be completed through a cost–consequence analysis from an education sector perspective.Ethics and dissemination Ethical approval was obtained from the University of Birmingham’s Research Ethics Committee (ERN_22-0723). Parents/carers of pupil participants can complete a form to opt their child out of the study. Pupil, school staff and parent/carer participants are asked to complete online/written consent (or assent). Findings will be disseminated through policy briefings, resources for schools, social media, reports, and open access publications.Trial registration number ISRCTN77948572.

Gastric varices (GVs) are reported in up to 20% of patients with portal hypertension, and bleeding is often more severe and challenging than esophageal variceal bleeding. Data are limited on prophylaxis of GV bleeding or management in the acute setting, and different techniques are used. This study evaluated outcomes after EUS-guided placement of coils in combination with thrombin to manage GVs. We retrospectively reviewed all patients treated with combination EUS-guided therapy with coils and thrombin between October 2015 and February 2020. Twenty patients underwent 33 procedures for GV therapy; 16 of 20 (80%) had type 1 isolated GVs and 4 patients had type 2 gastroesophageal varices. The median follow-up was 842 days (interquartile range [IQR], 483-961). Seventeen patients (85%) had underlying cirrhosis, the most common etiologies being alcohol-related liver disease and nonalcoholic steatohepatitis. The median Child-Pugh score was 6 (IQR, 5-7). In 11 patients (55%), the indication was secondary prophylaxis to prevent recurrent bleeding; in 2 of 20 patients (10%), the bleeding was acute. Technical success was achieved in 19 patients (95%). During follow-up, the obliteration of flow within the varices was achieved in 17 patients (85%). The 6-week survival rate was 100%, and 2 adverse events, recurrent bleeding at day 5 and at day 37, were reported; both recurrent bleeding events were successfully managed endoscopically. EUS-guided GV obliteration combining coil placement with thrombin, in our experience, was technically safe with good medium-term efficacy. A multicenter randomized controlled trial comparing different treatment strategies is desirable to understand options better. [ABSTRACT FROM AUTHOR]

Rapid growth in various industrial fields has introduced a series of new environmental risks. The textile industry is one of the major industries that is influenced by rapid advancements in technological sectors. The development in textile dying technologies has presented new types of dyes that are toxic to the ecosystem. Azo dyes are the main artificial dyes used in textiles, food, and other applications. Typically, these dyes are introduced into the environment as wastewater discharged from factories. The discharged influence penetrates the ecosystem and causes deadly diseases to human and animals. Several studies present activated carbon as a proper solution to eliminating the presence of azo dyes in the environment. However, various types of azo dye have different properties and chemical structures. Thus, there is a crucial need for more studies on the application of activated carbons to eliminate the presence of azo dyes in the environment. This paper discusses the toxic effects of azo dyes on the environment and human health. Moreover, this work presents a general review of the preparation of activated carbon and the parameters that influence the adsorption performance.

Background: Primary care and community healthcare professionals (HCPs) are well placed to discuss child excess weight with parents and support them to make changes. However, HCPs have concerns about addressing this issue. There is a need to understand the factors that influence HCPs in initiating these conversations to inform strategies to support them. Aim: To explore with HCPs, working in primary care and community settings, their experiences of having conversations about child weight with parents, and the factors that create barriers or facilitate them to have these conversations. Design and setting: A qualitative study with GPs, primary care nurses (PNs), and school nurses (SNs) in England. Method: GPs and PNs were recruited to participate in semi-structured interviews. SNs from a community healthcare NHS trust were recruited to participate in focus groups. Vignettes were used to stimulate discussion. Data were analysed guided by the Framework approach. Results: Thirteen GPs, seven PNs, and 20 SNs participated. The following three themes were identified regarding barriers to HCPs having conversations about child excess weight: structural and organisational; HCP related; and parent or family related. The themes identified for the factors that facilitate these conversations were: structural changes (for example, dedicated appointments, access to weight assessment data, joined-up working across agencies); HCP approaches (for example, providing appropriate dietary and physical activity advice); and HCP knowledge and skills (for example, enhancing HCPs' general and weight management-related skills and knowledge of child weight management services). Conclusion: A range of barriers exist to HCPs addressing child excess weight with parents in primary care and community settings. Actions to effect structural changes and support HCPs in developing relevant knowledge and skills are required to overcome these barriers. [ABSTRACT FROM AUTHOR]

This research involved comprehensive studies on thermal, physical, and morphological properties of SiO2-Na2O-CaO-P2O5 (SNCP) glass-ceramic at various sintering temperatures. The study in SNCP glass-ceramic using soda-lime-silica (SLS) wastes glass and clam shell (CS) wastes as the main raw of materials via conventional melt-quenching technique and solid state sintering are interesting and challenging by considering the research using waste materials to fabricate novel SNCP glass-ceramic. The main peaks, Na3PO4 and Ca3Na6Si6O18 were assigned to high crystallization temperature (Tc) at 650-950°C. The density of samples increases at 550-750°C and decreases at 850-950°C due to the increase of sample thickness and higher specific volume at high sintering temperature. FESEM micrograph showed that existed porous increased at sintering temperature 850-950°C contributes effect to low densification of the sample.

Background. Adjuvant immune checkpoint inhibitors are a new standard of care in melanoma. However, the immune related toxicity associated with these agents can be serious, and the long-term implications are yet to be defined especially in the adjuvant setting. We report, to our knowledge, the first case of anti-PD-1-induced eosinophilic asthma in a melanoma patient treated with adjuvant pembrolizumab. Case Presentation. A 72-year-old man commenced pembrolizumab in the adjuvant setting after resection of a stage IIIB cutaneous melanoma. The patient experienced episodes of breathlessness 4 weeks after cycle 1. These episodes were nocturnal and caused acute respiratory distress and cough, occasionally waking him up. The episodes progressed, and he was admitted after cycle 2 with a productive cough, wheeze, and breathlessness. Observations showed saturations on air of 94% and a respiratory rate of 19/min. The only laboratory abnormality was a raised eosinophil count of 1.1×109. Spirometry showed a FEV1 of 2.57 (91% predicted), FVC of 4.04 (108% predicted), and ratio of 64%. Peak expiratory flow rate was 94% predicted, and corrected gas transfer was 6.29 (78% predicted) with KCO 1.18 (93% predicted). FeNO was raised at 129 indicating inflammation of his airways, and peak flow was 422 l/min. CT of the chest did not show pneumonitis or other lung pathology. A diagnosis of acute eosinophilic asthma was made. Treatment with steroids and beclometasone dipropionate and formoterol inhaler produced rapid resolution of symptoms and normalisation of the eosinophil count. Pembrolizumab was safely recommenced once steroids had discontinued and symptoms had resolved. Conclusions. Specialist respiratory input was needed for optimal patient management and is ongoing. Although a safe rechallenge with pembrolizumab was possible, treatment in the adjuvant setting is curative in intent and long-term safety follow-up is required to assess for delayed toxicity and long-term health implications. This is likely to require large regional/national/international databases to detect, monitor, and educate the wider medical community as these patients are followed up in primary care following initial specialist follow-up.

Background Vitamin D deficiency (VDD) affects the health and wellbeing of millions worldwide. In high latitude countries such as the United Kingdom (UK), severe complications disproportionally affect ethnic minority groups. Objective To develop a decision-analytic model to estimate the cost effectiveness of population strategies to prevent VDD. Methods An individual-level simulation model was used to compare: (I) wheat flour fortification; (II) supplementation of at-risk groups; and (III) combined flour fortification and supplementation; with (IV) a 'no additional intervention' scenario, reflecting the current Vitamin D policy in the UK. We simulated the whole population over 90 years. Data from national nutrition surveys were used to estimate the risk of deficiency under the alternative scenarios. Costs incurred by the health care sector, the government, local authorities, and the general public were considered. Results were expressed as total cost and effect of each strategy, and as the cost per 'prevented case of VDD' and the 'cost per Quality Adjusted Life Year (QALY)'. Results Wheat flour fortification was cost saving as its costs were more than offset by the cost savings from preventing VDD. The combination of supplementation and fortification was cost effective (£9.5 per QALY gained). The model estimated that wheat flour fortification alone would result in 25% fewer cases of VDD, while the combined strategy would reduce the number of cases by a further 8%. Conclusion There is a strong economic case for fortifying wheat flour with Vitamin D, alone or in combination with targeted vitamin D3 supplementation., Author(s): M. Aguiar [sup.1] [sup.2], L. Andronis [sup.1] [sup.3], M. Pallan [sup.1], W. Högler [sup.4] [sup.5], E. Frew [sup.1] Author Affiliations: (1) Institute of Applied Health Research, University of Birmingham, [...]

Objectives: Rapid socioeconomic and nutrition transitions in Chinese populations have contributed to the growth in childhood obesity. This study presents a cost-effectiveness analysis of a school- and family-based childhood obesity prevention programme in China.Methods: A trial-based economic evaluation assessed cost-effectiveness at 12 months. Forty schools with 1,641 children were randomised to either receive the multi-component (diet and physical activity) intervention or to continue with usual activities. Both public sector and societal perspectives were adopted. Costs and benefits in the form of quality-adjusted life years (QALYs) were compared and uncertainty was assessed using established UK and US thresholds.Results: The intervention cost was 35.53 Yuan (£7.04/US$10.01) per child from a public sector perspective and 536.95 Yuan (£106/US$151) from a societal perspective. The incremental cost-effectiveness ratio (ICER) was 272.7 Yuan (£54/US$77)/BMI z-score change. The ICER was 8,888 Yuan (£1,760/US$2,502) and 73,831 Yuan (£14,620/US$20,796) per QALY from a public sector and societal perspective, respectively and was cost-effective using UK (£20,000) and US (US$50,000) per QALY thresholds.Conclusion: A multi-component school-based prevention programme is a cost-effective means of preventing childhood obesity in China.

Background: More men than women in the UK are living with overweight or obesity, but men are less likely to engage with weight loss programmes. Healthy Dads, Healthy Kids is an effective Australian weight management programme that targets fathers, who participate with their primary school-aged children. Behavioural interventions do not always transfer between contexts, so an adaptation of the Healthy Dads, Healthy Kids programme to an ethnically diverse UK setting was trialled. Objectives: To adapt and test the Australian Healthy Dads, Healthy Kids programme for delivery to men in an ethnically diverse, socioeconomically disadvantaged UK setting. Design: Phase 1a studied the cultural adaptation of the Healthy Dads, Healthy Kids programme and was informed by qualitative data from fathers and other family members, and a theoretical framework. Phase 1b was an uncontrolled feasibility trial. Phase 2 was a randomised controlled feasibility trial. Setting: Two ethnically diverse, socioeconomically disadvantaged UK cities. Participants: In phase 1a, participants were parents and family members from black and minority ethnic groups and/or socioeconomically deprived localities. In phases 1b and 2, participants were fathers with overweight or obesity and their children aged 4–11 years. Interventions: The adapted Healthy Dads, Healthy Kids intervention comprised nine sessions that targeted diet and physical activity and incorporated joint father–child physical activity. Healthy Dads, Healthy Kids was delivered in two programmes in phase 1b and four programmes in phase 2. Those in the comparator arm in phase 2 received a family voucher to attend a local sports centre. Main outcome measures: The following outcomes were measured: recruitment to the trial, retention, intervention fidelity, attendance, feasibility of trial processes and collection of outcome data. Results: Forty-three fathers participated (intervention group, n = 29) in phase 2 (48% of recruitment target), despite multiple recruitment locations. Fathers’ mean body mass index was 30.2 kg/m2 (standard deviation 5.1 kg/m2); 60.2% were from a minority ethnic group, with a high proportion from disadvantaged localities. Twenty-seven (63%) fathers completed follow-up at 3 months. Identifying sites for delivery at a time that was convenient for the families, with appropriately skilled programme facilitators, proved challenging. Four programmes were delivered in leisure centres and community venues. Of the participants who attended the intervention at least once (n = 20), 75% completed the programme (attended five or more sessions). Feedback from participants rated the sessions as ‘good’ or ‘very good’ and participants reported behavioural change. Researcher observations of intervention delivery showed that the sessions were delivered with high fidelity. Conclusions: The intervention was well delivered and received, but there were significant challenges in recruiting overweight men, and follow-up rates at 3 and 6 months were low. We do not recommend progression to a definitive trial as it was not feasible to deliver the Healthy Dads, Healthy Kids programme to fathers living with overweight and obesity in ethnically diverse, socioeconomically deprived communities in the UK. More work is needed to explore the optimal ways to engage fathers from ethnically diverse socioeconomically deprived populations in research. Trial registration: Current Controlled Trials ISRCTN16724454. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 2. See the NIHR Journals Library website for further project information.