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Background: We have developed a healthy lifestyles programme (HeLP) for primary school aged children (9-10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial.Methods: Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months.Results: At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0-13) energy dense snacks (EDS) and 3.23 (0-9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than 'light' intensity activity. Less than 5% of children achieved the Departments of Health's recommendation of 60 min of MVPA every day.Conclusion: We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen before in other large scale studies. Our anthropometric baseline data is representative of local and national data for children this age and reflects the gender and socio-economic variations expected of children this age in relation to physical activity and weight status.Trial Registration: ISRCTN15811706 (1/05/2012). [ABSTRACT FROM AUTHOR]

Background: Around a fifth of children starting school in England are now overweight/obese. There is a paucity of interventions with the aim of obesity prevention in preschool-age children in the UK. Previous research has demonstrated some positive results in changing specific health behaviours, however, positive trends in overall obesity rates are lacking. Preschool settings may provide valuable opportunities to access children and their families not only for promoting healthy lifestyles, but also to develop and evaluate behaviour-change interventions.Methods: This paper presents a cluster randomised feasibility study of a theory based behaviour-change preschool practitioner-led intervention tested in four preschool centres in the North East of England. The primary outcome measures were to test the acceptability and feasibility of the data collection measures and intervention. Secondary measures were collected and reported for extra information. At baseline and post intervention, children's anthropometric, dietary and physical activity measures as well as family 'active' time data were collected. The preschool practitioner-led intervention included family intervention tasks such as 'family goal-setting activities' and 'cooking challenges'. Preschool activities included increasing physical activity and providing activities with the potential to change behaviour with increased knowledge of and acceptance of healthy eating. The process evaluation was an on-going monthly process and was collected in multiple forms such as questionnaires, photographs and verbal feedback.Results: 'Gatekeeper' permission and lower-hierarchal adherence were initially a problem for recruitment and methods acceptance. However, at intervention end the preschool teachers and parents stated they found most intervention methods and activities acceptable, and some positive changes in family health behaviours were reported. However, the preschool centres appeared to have difficulties with enforcing everyday school healthy eating policies.Conclusions: The findings from the current study may have implications for nursery practitioners, nursery settings, Local Educational Authorities and policy makers, and contributes to the body of literature. However, further work with preschool practitioners is required to determine how personal attitudes and school policy application can be supported to implement successfully such an intervention.Trial Registration: ISRCTN12345678 (16/02/17) retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Screening with the guaiac faecal occult blood test (gFOBt) is associated with improved colorectal cancer (CRC) survival, and is offered biennially to men and women aged 60-74 years in England's national Bowel Cancer Screening Programme (BCSP). Uptake of the gFOBt is low, with only 54 % of the eligible population completing the test. Text-message reminders could improve uptake of gFOBt.Methods/design: This paper describes the protocol for a randomised controlled trial, which will examine the effectiveness of a text-message reminder to promote uptake of gFOBt screening in the BCSP. Individual mobile telephone data from 180 general practices in London with existing mobile-health services will be linked to the national BCSP information system via a secure on-line network. All screening-eligible adults registered with a participating practice will be randomised, to receive either usual care (N = 1600) or usual care plus a text-message reminder to self-complete and return their kit eight weeks after their initial invitation (N = 1600). The primary outcome will be the proportion of individuals who return an adequately completed gFOBt kit within 18 weeks of the initial invitation. Differences in uptake between groups will be evaluated using a logistic regression analysis, adjusting for individual-level and area-level socio-demographic variables.Discussion: This will be the first large-scale randomised trial of a text-message reminder in a national screening programme for CRC. If effective, this study provides a cost-effective means to promote uptake of CRC screening in an organised programme.Trial Registration: Current Controlled Trials ISRCTN70904476 (18/09/2015). [ABSTRACT FROM AUTHOR]

Background: January 2016 saw the publication of proposed revisions to the UK's lower risk drinking guidelines but no sustained promotional activity. This paper aims to explore the impact of publishing guidelines without sustained promotional activity on reported guideline exposure and determinants of behaviour (capability, opportunity and motivation) proposed by the COM-B model.Methods: Data were collected by a monthly repeat cross-sectional survey of adults (18+) resident in England over 15 months between November 2015 and January 2017 from a total of 16,779 drinkers, as part of the Alcohol Toolkit Study. Trends and associated 95% confidence intervals were described in the proportion of reported exposure to guidelines in the past month and measures of the capability, opportunity and motivation to consume alcohol within drinking guidelines.Results: There was a rise in reported exposure to drinking guidelines in January 2016 (57.6-80.6%) which did not reoccur in January 2017. Following the increase in January 2016, reported exposure reduced slowly but remained significantly higher than in December 2015. In February 2016, there was an increase in measures of capability (31.1% reported tracking units of alcohol consumption and 87.8% considered it easier to drink safely) and opportunity (84.0% perceived their lifestyle as conducive to drinking within guidelines). This change was not maintained in subsequent months. Other measures showed marginal changes between January and February 2016 with no evidence of change in subsequent months.Conclusions: Following the publication of revised drinking guideline in January 2016, there was a transient increase in exposure to guidelines, and capability and opportunity to drink within the guidelines that diminished over time. The transience and size of the changes indicate that behaviour change is unlikely. Well-designed, theory-based promotional campaigns may be required for drinking guidelines to be an effective public health intervention. [ABSTRACT FROM AUTHOR]

Background: Previous research has shown the benefits of arts and cultural engagement for physical, mental and social wellbeing. This engagement is socially and geographically patterned. Yet it remains unclear whether place-based attributes are associated with engagement behaviour independent of individual factors. Therefore, the aim of this cross-sectional study was to robustly disentangle associations between geographical deprivation and arts engagement from the individual socio-demographic factors that tend to correlate with residential locations.Methods: Two different samples drawn from two representative surveys of adults living in England were compared - Understanding Society Wave 2 (2010/12) (N = 14,782) and Taking Part survey (2010/11) (N = 4575). Propensity score matching (PSM) was applied to investigate the association between neighbourhood deprivation (20% most deprived vs 20% least deprived) and arts engagement (arts participation, cultural attendance and museums and heritage engagement).Results: Higher levels of neighbourhood deprivation were associated with lower arts, culture and heritage engagement independent of individuals' demographic backgrounds, socio-economic characteristics and regional locations. When exploring subcategories of deprivation, similar results were obtained across deprivation domains. Results were also consistent when using more distinct categories of deprivation (i.e. 10% most deprived vs 10% least deprived) and when comparing people living in the 20% most deprived neighbourhoods with those living in the 40% medium-deprived areas.Conclusion: This study is the first to apply a robust PSM technique to examine the association between neighbourhood deprivation and arts engagement using two nationally-representative samples. Results show that neighbourhood deprivation may act as a barrier that could prevent people from engaging in the arts, which in turn may exacerbate social and health inequalities. This highlights the importance of place-based schemes that focus on increasing individual motivation and capacity to engage in arts and cultural activities, especially in areas of high deprivation. [ABSTRACT FROM AUTHOR]

Background: The workplace has been identified as an ideal setting for health interventions. However, few UK-based workplace intervention studies have been published. Fewer still focus on the practicalities and implications when running an intervention within the workplace setting. The objective of this paper was to qualitatively determine the perceived behaviour changes of participants in a free fruit at work intervention. Understanding the dynamics of a workplace intervention and establishing any limitations of conducting an intervention in a workplace setting were also explored.Methods: Twenty-three face-to-face interviews were conducted with individuals receiving free fruit at work for 18 weeks (74 % female). The worksite was the offices of a regional local government in the North East of England. Analysis was guided theoretically by Grounded Theory research and the data were subjected to content analysis. The transcripts were read repeatedly and cross-compared to develop a coding framework and derive dominant themes.Results: Topics explored included: the workplace food environment; the effect of the intervention on participants and on other related health behaviours; the effect of the intervention on others; participant's fruit consumption; reasons for not taking part in the intervention; expectations and sustainability post-intervention; and how to make the workplace healthier. Five emergent themes included: the office relationship with food; desk based eating; males and peer support; guilt around consumption of unhealthy foods; and the type of workplace influencing the acceptability of future interventions.Conclusion: Exploring the perceptions of participants offered valued insights into the dynamics of a free fruit workplace intervention. Findings suggest that access and availability are both barriers and facilitators to encouraging healthy eating in the workplace. [ABSTRACT FROM AUTHOR]

Background: Active for life year 5 (AFLY5) is a school-based intervention, based on social cognitive theory, which aims to promote healthy levels of physical activity and healthy eating by improving a child's self-efficacy to make healthy choices, their knowledge of how to make such choices and prompting parents to support their children to make healthy choices. Previously published results showed no effect on the three primary outcomes and beneficial effects on three of nine secondary outcomes (time spent screen-viewing at weekends, consumption of snacks and of high energy drinks). This paper aims to determine the effect of the intervention on potential mediators.Methods: We conducted a cluster RCT of a school-based intervention, with allocation concealed by use of a remote system. The study was undertaken in the South West of England between 2011 and 2013. Participants were school children who were age 8-9 years at baseline assessment and 9-10 years during the intervention. Potential mediators were assessed at the end of the intervention. The intervention consisted of teacher training, provision of all materials required for lessons and homeworks and written materials for school newsletters and parents. The ten potential mediators were child-reported self-efficacy for physical activity and fruit and vegetable consumption, perceived parental logistic support and modelling for their child's physical activity, parental efforts to limit their child's sedentary behaviour and modelling of healthy fruit and vegetable consumption, together with a knowledge assessment.Results: We successfully recruited 60 schools with over 2,221 children; valid data for the 10 mediators were available for 87 % to 96 % of participants. Three of the ten potential mediators were greater in the intervention, compared with the control group: fruit and vegetable self-efficacy 2.2 units (95 % CI: 0.7 to 3.8), assessed on a scale 26 to 130; child-reported maternal limitation of sedentary behaviour 0.5 (0.1 to 0.8), scale 4 to 16; and knowledge 0.5 (0.2, 0.7) scale 0 to 9. Reported maternal limitation of sedentary behaviour and the child's knowledge explained 23 % of the effect of the intervention on reducing time spent on sedentary behaviour at the weekend. There was no effect on other mediators.Conclusions: Our findings suggest that the effect of the AFLY5 intervention on reducing screen-viewing at weekends was partially mediated by an effect on mothers limiting their child's time spent sedentary and on increasing the child's knowledge about healthy behaviour. However, overall our findings suggest that theory driven interventions, like AFLY5, can fail to influence most potential mediators and this may explain the failure of the intervention to improve most primary and secondary outcomes.Trial Registration: Current Controlled Trials ISRCTN50133740. Registered 17/03/2011. [ABSTRACT FROM AUTHOR]

Background: Much of the food available from takeaways, pubs and restaurants particularly that sold by independent outlets, is unhealthy and its consumption is increasing. These food outlets are therefore important potential targets for interventions to improve diet and thus prevent diet related chronic diseases. Local authorities in England have been charged with delivering interventions to increase the provision of healthy food choices in independent outlets, but prior research shows that few such interventions have been rigorously developed or evaluated. We aimed to learn from the experiences of professionals delivering interventions in independent food outlets in England to identify the operational challenges and their suggestions for best practice.Methods: We used one-to-one semi-structured qualitative interviews to explore the views and experiences of professionals who were either employees of, or contracted by, a local authority to deliver interventions to increase the provision of healthier food choices in independent food outlets. Purposive sampling was used to recruit a sample which included men and women, from a range of professional roles, across different areas of England. Interviews were informed by a topic guide, and proceeded until no new themes emerged. Interviews were recorded, transcribed verbatim and analysed using the Framework method.Results: We conducted 11 individual interviews. Participants focussed on independent takeaways and their unhealthy food offerings, and highlighted the advantages and disadvantages of intervention delivery methods, their evaluation and impact. The main barriers to implementation of interventions in independent takeaways were identified as limited funding and the difficulties of engaging the food outlet owner/manager. Engagement was thought to be facilitated by delivering intensive, interactive and tailored interventions, clear and specific information, and incentives, whilst accounting for practical, primarily financial, constraints of food businesses. Alternative intervention approaches, targeting suppliers or customers, were suggested.Conclusions: Participants emphasised independent takeaways as particularly challenging, but worthwhile intervention targets. Participants perceived that interventions need to take account of the potentially challenging operating environment, particularly the primacy of the profit motive. Upstream interventions, engaging suppliers, as well as those that drive consumer demand, may be worth exploring. Rigorous, evidence-informed development and evaluation of such interventions is needed. [ABSTRACT FROM AUTHOR]

Background: The challenges of delivering interventions for pregnant smokers have been poorly documented. Also, the process of promoting a physical activity intervention for pregnant smokers has not been previously recorded. This study describes the experiences of researchers conducting a randomised controlled trial of physical activity as an aid to smoking cessation during pregnancy and explores how the effectiveness of future interventions could be improved.Methods: Two focus groups, with independent facilitators, were conducted with six researchers who had enrolled pregnant smokers in the LEAP trial, provided the interventions, and administered the research measures. Topics included recruitment, retention and how the physical activity intervention for pregnant smokers was delivered and how it was adapted when necessary to suit the women. The focus groups were audio-recorded, transcribed verbatim and subjected to thematic analysis.Results: Five themes emerged related to barriers or enablers to intervention delivery: (1) nature of the intervention; (2) personal characteristics of trial participants; (3) practical issues; (4) researchers' engagement with participants; (5) training and support needs. Researchers perceived that participants may have been deterred by the intensive and generic nature of the intervention and the need to simultaneously quit smoking and increase physical activity. Women also appeared hampered by pregnancy ailments, social deprivation, and poor mental health. Researchers observed that their status as health professionals was valued by participants but it was challenging to maintain contact with participants. Training and support needs were identified for dealing with pregnant teenagers, participants' friends and family, and post-natal return to smoking.Conclusions: Future exercise interventions for smoking cessation in pregnancy may benefit by increased tailoring of the intervention to the characteristics of the women, including their psychological profile, socio-economic background, pregnancy ailments and exercise preferences. Delivering an effective physical activity intervention for smoking cessation in pregnancy may require more comprehensive training for those delivering the intervention, particularly with regard to dealing with teenage smokers and smokers' friends and family, as well as for avoiding post-natal return to smoking.Trial Registration: ISRCTN48600346 , date of registration: 21/07/2008. [ABSTRACT FROM AUTHOR]

Background: This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk.Methods: NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm.Discussion: The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered diabetes prevention intervention, supported by lay mentors with T2DM, with intervention in multiple at risk glycaemic categories, and that takes into account the realities of normal clinical practice.Trial Registration: ISRCTN34805606 (Retrospectively registered 16.3.16). [ABSTRACT FROM AUTHOR]

Background: Between 1997 and 2010, the English government pursued an ambitious programme to reduce health inequalities, the explicit and sustained commitment of which was historically and internationally unique. Previous evaluations have produced mixed results. None of these evaluations have, however, compared the trends in health inequalities within England with those in other European countries. We carried out an innovative analysis to assess whether changes in trends in health inequalities observed in England after the implementation of its programme, have been more favourable than those in other countries without such a programme.Methods: Data were obtained from nationally representative surveys carried out in England, Finland, the Netherlands and Italy for years around 1990, 2000 and 2010. A modified difference-in-difference approach was used to assess whether trends in health inequalities in 2000-2010 were more favourable as compared to the period 1990-2000 in England, and the changes in trends in inequalities after 2000 in England were then compared to those in the three comparison countries. Health outcomes were self-assessed health, long-standing health problems, smoking status and obesity. Education was used as indicator of socioeconomic position.Results: After the implementation of the English strategy, more favourable trends in some health indicators were observed among low-educated people, but trends in health inequalities in 2000-2010 in England were not more favourable than those observed in the period 1990-2000. For most health indicators, changes in trends of health inequalities after 2000 in England were also not significantly different from those seen in the other countries.Conclusions: In this rigorous analysis comparing trends in health inequalities in England both over time and between countries, we could not detect a favourable effect of the English strategy. Our analysis illustrates the usefulness of a modified difference-in-difference approach for assessing the impact of policies on population-level health inequalities. [ABSTRACT FROM AUTHOR]

Background: In 2010, the "Tackling Suicide on the Railways" programme was launched as a joint initiative among Network Rail, the Samaritans and other key organisations such as the British Transport Police and train operators to achieve a 20% reduction in railway suicides from 2010 to 2015 in Great Britain. We report the most recent age and sex specific trends in railway suicide in England and Wales from 2000 to 2013 and examine whether the initiative's target reduction in railway suicides is likely to be achieved.Methods: Population data and suicide mortality data (all methods combined and railway) for England and Wales were obtained from the Office for National Statistics (ONS) and used to calculate age and gender specific rates for deaths registered from 2000 to 2013. Data on railway suicides were also obtained from the Rail Safety and Standards Board (RSSB) and compared with ONS data. We used joinpoint regression to identify changes in suicide trends across the study period.Results: The railway was used in 4.1% of all suicides in England and Wales (RSSB data were similar to ONS data for most years). Suicides in all persons from all causes decreased from 2000 to 2007, with small increases from 2008 until 2013; this rise was entirely due to an increase in male suicides. Railway suicide rates increased over the entire study period; the proportion of railway suicides in all persons increased from 3.5 to 4.9% during the study period. This trend was also mainly driven by increases in male suicides as female railway suicide rates remained steady over time. The highest age specific railway suicide rates were observed in middle aged men and women. Although there was no conclusive evidence of an increase in ONS railway suicides, RSSB data showed a statistically significant increase in railway suicides in males from 2009 onwards.Conclusion: The continued rise in male railway suicide in England and Wales is concerning, particularly due to the high economic costs and psychological trauma associated with these deaths. The initiative's target of a 20% reduction in railway suicide is unlikely to be achieved. [ABSTRACT FROM AUTHOR]

Background: Early interventions are recognised as key to improving life chances for children and reducing inequalities in health and well-being, however there is a paucity of high quality research into the effectiveness of interventions to address childhood health and development outcomes. Planning and implementing standalone RCTs for multiple, individual interventions would be slow, cumbersome and expensive. This paper describes the protocol for an innovative experimental birth cohort: Born in Bradford's Better Start (BiBBS) that will simultaneously evaluate the impact of multiple early life interventions using efficient study designs. Better Start Bradford (BSB) has been allocated £49 million from the Big Lottery Fund to implement 22 interventions to improve outcomes for children aged 0-3 in three key areas: social and emotional development; communication and language development; and nutrition and obesity. The interventions will be implemented in three deprived and ethnically diverse inner city areas of Bradford.Method: The BiBBS study aims to recruit 5000 babies, their mothers and their mothers' partners over 5 years from January 2016-December 2020. Demographic and socioeconomic information, physical and mental health, lifestyle factors and biological samples will be collected during pregnancy. Parents and children will be linked to their routine health and local authority (including education) data throughout the children's lives. Their participation in BSB interventions will also be tracked. BiBBS will test interventions using the Trials within Cohorts (TwiCs) approach and other quasi-experimental designs where TwiCs are neither feasible nor ethical, to evaluate these early life interventions. The effects of single interventions, and the cumulative effects of stacked (multiple) interventions on health and social outcomes during the critical early years will be measured.Discussion: The focus of the BiBBS cohort is on intervention impact rather than observation. As far as we are aware BiBBS is the world's first such experimental birth cohort study. While some risk factors for adverse health and social outcomes are increasingly well described, the solutions to tackling them remain elusive. The novel design of BiBBS can contribute much needed evidence to inform policy makers and practitioners about effective approaches to improve health and well-being for future generations. [ABSTRACT FROM AUTHOR]