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Many interventions that are delivered within public health services have little evidence of effect. Evaluating interventions that are being delivered as a part of usual practice offers opportunities to improve the evidence base of public health. However, such evaluation is challenging and requires the integration of research into system-wide practice. The Born in Bradford's Better Start experimental birth cohort offers an opportunity to efficiently evaluate multiple complex community interventions to improve the health, wellbeing and development of children aged 0-3 years. Based on the learning from this programme, this paper offers a pragmatic and practical guide to researchers, public health commissioners and service providers to enable them to integrate research into their everyday practice, thus enabling relevant and robust evaluations within a complex and changing system.Using the principles of co-production the key challenges of integrating research and practice were identified, and appropriate strategies to overcome these, developed across five key stages: 1) Community and stakeholder engagement; 2) Intervention design; 3) Optimising routinely collected data; 4) Monitoring implementation; and 5) Evaluation. As a result of our learning we have developed comprehensive toolkits ( https://borninbradford.nhs.uk/what-we-do/pregnancy-early-years/toolkit/ ) including: an operational guide through the service design process; an implementation and monitoring guide; and an evaluation framework. The evaluation framework incorporates implementation evaluations to enable understanding of intervention performance in practice, and quasi experimental approaches to infer causal effects in a timely manner. We also offer strategies to harness routinely collected data to enhance the efficiency and affordability of evaluations that are directly relevant to policy and practice.These strategies and tools will help researchers, commissioners and service providers to work together to evaluate interventions delivered in real-life settings. More importantly, however, we hope that they will support the development of a connected system that empowers practitioners and commissioners to embed innovation and improvement into their own practice, thus enabling them to learn, evaluate and improve their own services.

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.

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: Ready-to-eat meals (to eat in, to take away or to be delivered) sold by food outlets are often more energy dense and nutrient poor compared with meals prepared at home, making them a reasonable target for public health intervention. The aim of the research presented in this paper was to systematically identify and describe interventions to promote healthier ready-to-eat meals (to eat in, to take away, or to be delivered) sold by specific food outlets in England.Methods: A systematic search and sift of the literature, followed by evidence mapping of relevant interventions, was conducted. Food outlets were included if they were located in England, were openly accessible to the public and, as their main business, sold ready-to-eat meals. Academic databases and grey literature were searched. Also, local authorities in England, topic experts, and key health professionals and workers were contacted. Two tiers of evidence synthesis took place: type, content and delivery of each intervention were summarised (Tier 1) and for those interventions that had been evaluated, a narrative synthesis was conducted (Tier 2).Results: A total of 75 interventions were identified, the most popular being awards. Businesses were more likely to engage with cost neutral interventions which offered imperceptible changes to price, palatability and portion size. Few interventions involved working upstream with suppliers of food, the generation of customer demand, the exploration of competition effects, and/or reducing portion sizes. Evaluations of interventions were generally limited in scope and of low methodological quality, and many were simple assessments of acceptability.Conclusions: Many interventions promoting healthier ready-to-eat meals (to eat in, to take away, or to be delivered) sold by specific food outlets in England are taking place; award-type interventions are the most common. Proprietors of food outlets in England that, as their main business, sell ready-to-eat meals, can be engaged in implementing interventions to promote healthier ready-to-eat-food. These proprietors are generally positive about such interventions, particularly when they are cost neutral and use a health by stealth approach. [ABSTRACT FROM AUTHOR]

Background: Lifestyle interventions targeting physical activity, sedentary time and dietary behaviours have the potential to initiate and support behavioural change and result in public health gain. Although men have often been reluctant to engage in such lifestyle programs, many are at high risk of several chronic conditions. We have developed an evidence and theory-based, gender sensitised, health and lifestyle program (European Fans in Training (EuroFIT)), which is designed to attract men through the loyalty they feel to the football club they support. This paper describes the study protocol to evaluate the effectiveness and cost-effectiveness of the EuroFIT program in supporting men to improve their level of physical activity and reduce sedentary behaviour over 12 months.Methods: The EuroFIT study is a pragmatic, two-arm, randomised controlled trial conducted in 15 football clubs in the Netherlands, Norway, Portugal and the UK (England). One-thousand men, aged 30 to 65 years, with a self-reported Body Mass Index (BMI) ≥27 kg/m(2) will be recruited and individually randomised. The primary outcomes are objectively-assessed changes in total physical activity (steps per day) and total sedentary time (minutes per day) at 12 months after baseline assessment. Secondary outcomes are weight, BMI, waist circumference, resting systolic and diastolic blood pressure, cardio-metabolic blood biomarkers, food intake, self-reported physical activity and sedentary time, wellbeing, self-esteem, vitality and quality of life. Cost-effectiveness will be assessed and a process evaluation conducted. The EuroFIT program will be delivered over 12 weekly, 90-minute sessions that combine classroom discussion with graded physical activity in the setting of the football club. Classroom sessions provide participants with a toolbox of behaviour change techniques to initiate and sustain long-term lifestyle changes. The coaches will receive two days of training to enable them to create a positive social environment that supports men in engaging in sustained behaviour change.Discussion: The EuroFIT trial will provide evidence on the effectiveness and cost-effectiveness of the EuroFIT program delivered by football clubs to their male fans, and will offer insight into factors associated with success in making sustained changes to physical activity, sedentary behaviour, and secondary outcomes, such as diet.Trial Registration: Isrctn: 81935608 . Registered 16 June 2015. [ABSTRACT FROM AUTHOR]

Background: Stigma and discrimination associated with mental health problems is an important public health issue, and interventions aimed at reducing exposure to stigma and discrimination can improve the lives of people with mental health problems. Social contact has long been considered to be one of the most effective strategies for improving inter-group relations. For this study, we assess the impact of a population level social contact intervention among people with and without mental health problems., Methods: This study investigated the impact of social contact and whether presence of specific facilitating factors (equal status, common goals, cooperation and friendship potential): (1) improves intended stigmatising behaviour; (2) increases future willingness to disclose a mental health problem; and (3) promotes behaviours associated with anti-stigma campaign engagement. Two mass participation social contact programmes within England's Time to Change campaign were evaluated via a 2-part questionnaire. 403 participants completed initial questionnaires (70% paper, 30% online) and 83 completed follow-up questionnaires online 4-6 weeks later., Results: This study investigated the impact of social contact and whether presence of specific facilitating factors (equal status, common goals, cooperation and friendship potential): (1) improves intended stigmatising behaviour; (2) increases future willingness to disclose a mental health problem; and (3) promotes behaviours associated with anti-stigma campaign engagement. Two mass participation social contact programmes within England's Time to Change campaign were evaluated via a 2-part questionnaire. 403 participants completed initial questionnaires (70% paper, 30% online) and 83 completed follow-up questionnaires online 4-6 weeks later. Campaign events facilitated meaningful intergroup social contact between individuals with and without mental health problems. Presence of facilitating conditions predicted improved stigma-related behavioural intentions and subsequent campaign engagement 4-6 weeks following social contact. Contact, however, was not predictive of future willingness to disclose mental health problems., Conclusions: Findings emphasise the importance of facilitating conditions to promote positive social contact between individuals and also suggest that social contact interventions can work on a mass level. Future research should investigate this type of large scale intervention among broader and more representative populations.

Background: Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. A randomised controlled trial is needed to assess whether providing motivational interviewing, three months after giving initial advice, sustains physical activity levels in those who recently became physically active. This paper reports the results of an internal pilot study designed to test the feasibility of the study in terms of recruitment, per protocol delivery of the intervention and retention at three months., Methods: Participants were: aged 40-64 years; resident in deprived areas of Sheffield, UK; and, had recently become physically active as a result of using a brief intervention following an invitation from a mass mail out., Interventions: Motivational Interviewing 'boosters' aimed at sustaining change in physical activity status delivered face-to-face or over the telephone compared with no further intervention. Outcomes of the feasibility study: recruitment of 60 participants from mail out of 3,300; retention of 45 participants with 3-month follow-up accelerometry measurements; 70% of those randomised to boosters receiving intervention per protocol. Sample size and power were recalculated using the accelerometry data collected., Results: Forty-seven participants were randomised (78% of the feasibility target); 37 participants were retained at three months, 29 with at least four days of accelerometry data (64% of the feasibility target); 79% of those allocated boosters received them per protocol (surpassing the feasibility target). The proposed sample size of 600 was confirmed as appropriate and power is expected to be sufficient to detect a difference between groups., Conclusions: The main study will continue with the original recruitment target of 600 participants but to ensure feasibility, it is necessary to increase recruitment and improve the numbers of those followed-up who have evaluable data. Strategies will include increasing the number of initial invitations sent out and improving the training of research assistants and participants in the positioning of the accelerometer.

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: 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: Workplaces are a good setting for interventions that aim to support workers in achieving a healthier diet and body weight. However, little is known about the factors that impact on the feasibility and implementation of these interventions, and how these might vary by type of workplace and type of worker. The aim of this study was to explore the views of those involved in commissioning and delivering the Better Health at Work Award, an established and evidence-based workplace health improvement programme.Methods: One-to-one semi-structured interviews were conducted with 11 individuals in North East England who had some level of responsibility for delivering workplace dietary interventions. Interviews were transcribed verbatim and analysed using thematic framework analysis.Results: A number of factors were felt to promote the feasibility and implementation of interventions. These included interventions that were cost-neutral (to employee and employer), unstructured, involved colleagues for support, took place at lunchtimes, and were well-advertised and communicated via a variety of media. Offering incentives, not necessarily monetary, was perceived to increase recruitment rates. Factors that militate against feasibility and implementation of interventions included worksites that were large in size and remote, working patterns including shifts and working outside of normal working hours that were not conducive to workers being able to access intervention sessions, workplaces without appropriate provision for healthy food on site, and a lack of support from management.Conclusions: Intervention deliverers perceived that workplace dietary interventions should be equally and easily accessible (in terms of cost and timing of sessions) for all staff, regardless of their job role. Additional effort should be taken to ensure those staff working outside normal working hours, and those working off-site, can easily engage with any intervention, to avoid the risk of intervention-generated inequalities (IGIs). [ABSTRACT FROM AUTHOR]

Background: Evidence-based approaches are requisite in evaluating public health programmes. Nowhere are they more necessary than physical activity interventions where evidence of effectiveness is often poor, especially within hard to reach groups. Our study reports on the quality of the evaluation of a government funded walking programme in five 'Walking Cities' in England. Cities were required to undertake a simple but robust evaluation using the Standard Evaluation Framework (SEF) for physical activity interventions to enable high quality, consistent evaluation. Our aim was not to evaluate the outcomes of this programme but to evaluate whether the evaluation process had been effective in generating new and reliable evidence on intervention design and what had worked in 'real world' circumstances.Methods: Funding applications and final reports produced by the funder and the five walking cities were obtained. These totalled 16 documents which were systematically analysed against the 52 criteria in the SEF. Data were cross checked between the documents at the bid and reporting stage with reference to the SEF guidance notes.Results: Generally, the SEF reporting requirements were not followed well. The rationale for the interventions was badly described, the target population was not precisely specified, and neither was the method of recruitment. Demographics of individual participants, including socio-economic status were reported poorly, despite being a key criterion for funding.Conclusions: Our study of the evaluations demonstrated a missed opportunity to confidently establish what worked and what did not work in walking programmes with particular populations. This limited the potential for evidence synthesis and to highlight innovative practice warranting further investigation. Our findings suggest a mandate for evaluability assessment. Used at the planning stage this may have ensured the development of realistic objectives and crucially may have identified innovative practice to implement and evaluate. Logic models may also have helped in the development of the intervention and its means of capturing evidence prior to implementation. It may be that research-practice partnerships between universities and practitioners could enhance this process. A lack of conceptual clarity means that replicability and scaling-up of effective interventions is difficult and the opportunity to learn from failure lost. [ABSTRACT FROM AUTHOR]

Background: Levels of physical activity remain low, particularly in deprived areas. Improving the street environment to promote walking for transport using a community engagement approach is a potential strategy to increase physical activity. An understanding of the implementation of this intervention approach is needed to facilitate further research, replication and scale-up. The aim of this study was to evaluate the implementation of the Fitter for Walking (FFW) intervention in deprived neighbourhoods.Methods: FFW was delivered in five regions of England between August 2008 and March 2012 and aimed to use a community engagement approach to improve the street environment to promote walking for transport. Implementation was assessed in relation to reach; dosage; implementation processes and adaptation; and factors influencing implementation. Three data sources were used: focus groups and face-to-face interviews with coordinators; implementation logs; and participation records.Results: Reach: 155 community groups participated in FFW engaging 30,230 local residents. Dosage: A wide variety of environmental improvements were implemented by local authorities (LAs) (42 projects) and by communities (46 projects). Examples of LA-led improvements included removal of encroaching vegetation, new/improved pedestrian signage, new dropped kerbs/kerb improvements and new, repaired or improved footpaths. Examples of community-led improvements included planting bulbs, shrubs or bedding plants, clean-up days and litter pick-ups. In 32 projects, no environmental improvements were implemented. Promotional and awareness-raising activities were undertaken in 81 projects. Examples included led walks, themed walks, development of maps/resources to promote improved routes and community events. Processes and adaptation: The need for a planning phase, a preparatory phase, and a delivery phase with a four step process were identified. Adaptability to local context was important. Factors influencing implementation: Five key themes were identified in relation to the barriers and facilitators of implementing FFW: local knowledge and contacts; intervention delivery; coordinator role; working with LAs and other partners; and working with communities.Conclusions: FFW is one of few reported interventions which have used a community engagement approach to change the street environment to promote walking for transport in deprived neighbourhoods. Delivering these types of interventions is complex and requires considerable resource and time. A set of recommendations and an implementation framework are proposed for future delivery of this and similar types of programme. [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: Providing financial incentives contingent on healthy behaviours is one way to encourage healthy behaviours. However, there remains substantial concerns with the acceptability of health promoting financial incentives (HPFI). Previous research has studied acceptability of HPFI to the public, recipients and practitioners. We are not aware of any previous work that has focused particularly on the views of public health policymakers. Our aim was to explore the views of public health policymakers on whether or not HPFI are acceptable; and what, if anything, could be done to maximise acceptability of HPFI.Methods: We recruited 21 local, regional and national policymakers working in England via gatekeepers and snowballing. We conducted semi-structured in-depth interviews with participants exploring experiences of, and attitudes towards, HPFI. We analysed data using the Framework approach.Results: Public health policymakers working in England acknowledged that HPFI could be a useful behaviour change tool, but were not overwhelmingly supportive of them. In particular, they raised concerns about effectiveness and cost-effectiveness, potential 'gaming', and whether or not HPFI address the underlying causes of unhealthy behaviours. Shopping voucher rewards, of smaller value, targeted at deprived groups were particularly acceptable to policymakers. Participants were particularly concerned about the response of other stakeholders to HPFI - including the public, potential recipients, politicians and the media. Overall, the interviews reflected three tensions. Firstly, a tension between wanting to trust individuals and promote responsibility; and distrust around the potential for 'gaming the system'. Secondly, a tension between participants' own views about HPFI; and their concerns about the possible views of other stakeholders. Thirdly, a tension between participants' personal distaste of HPFI; and their professional view that they could be a valuable behaviour change tool.Conclusions: There are aspects of design that influence acceptability of financial incentive interventions to public health policymakers. However, it is not clear that even interventions designed to maximise acceptability would be acceptable enough to be recommended for implementation. Further work may be required to help policymakers understand the potential responses of other stakeholder groups to financial incentive interventions. [ABSTRACT FROM AUTHOR]

Background: PE lessons are the formal opportunity in schools for promotion of physical activity and fitness. This study aimed to evaluate the effectiveness of a pilot PE intervention on physical activity, fitness, and psychosocial outcomes.Methods: Participants were 139 children aged 10-11 years from four schools. For six weeks children in two schools received a twice-weekly pilot 'Born to Move' (BTM) physical activity (PA) and fitness intervention alongside one regular PE lesson. Children in the two comparison (COM) schools received their regular twice weekly PE lessons. Outcomes were lesson time and whole-day light (LPA), moderate (MPA), vigorous (VPA), and MVPA, and sedentary time, muscular fitness, cardiorespiratory fitness (CRF), and lesson-specific perceived exertion, enjoyment, and perceived competence. Outcomes were assessed at baseline (T0), midway through the intervention (T1), and at the end (T2) using ANOVAs and ANCOVAs. Intervention fidelity was measured using child and teacher surveys at T2 and analysed using Chi-square tests.Results: The BTM group engaged in moderate PA for significantly more lesson time (29.4 %) than the COM group (25.8 %; p = .009, d = .53). The amount of moderate-to-vigorous PA (MVPA) during the T1 BTM lesson contributed 14.0 % to total MVPA, which was significantly more than the COM group's T1 PE lesson (11.4 %; p < .001, d = .47). The BTM group were significantly more active during the whole-day (p < .05) and the school-day (p < .01). In both groups push-up test performance increased (p < .001) and CRF test performance decreased (p < .01). Perceived exertion, enjoyment, and perceived competence increased in both groups (p < .05), but the BTM group rated their enjoyment of the T1 BTM lesson higher than the COM group rated their PE lesson (p = .02, d = .56). The children's and teachers' responses to the intervention indicated that the delivery aims of enjoyment, engagement, inclusivity, and challenge were satisfied.Conclusions: The BTM pilot programme has potential to positively impact on physical activity, fitness, and psychosocial outcomes. Further, BTM was enjoyed by the children, and valued by the teachers. This study can inform the design of a modified larger-scale cluster RCT evaluation. [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: We evaluated the cost-effectiveness of the Give-it-a-Go programme, which offers free leisure centre memberships to physically inactive members of the public in a single London Borough receiving state benefits.Methods: A decision analytic Markov model was developed to analyse lifetime costs and quality-adjusted life-years (QALYs) of 1025 people recruited to the intervention versus no intervention. In the intervention group, people were offered 4 months of free membership at a leisure centre. Physical activity levels were assessed at 0 and 4 months using the International Physical Activity Questionnaire (IPAQ). Higher levels of physical activity were assumed to decrease the risk of coronary heart disease, stroke and diabetes mellitus type II, as well as improve mental health. Costs were assessed from a National Health Service (NHS) perspective. Uncertainty was assessed using one-way and probabilistic sensitivity analyses.Results: One-hundred fifty nine participants (15.5 %) completed the programme by attending the leisure centre for 4 months. Compared with no intervention, Give it a Go increased costs by £67.25 and QALYs by 0.0033 (equivalent to 1.21 days in full health) per recruited person. The incremental costs per QALY gained were £20,347. The results were highly sensitive to the magnitude of mental health gain due to physical activity and the duration of the effect of the programme (1 year in the base case analysis). When the mental health gain was omitted from the analysis, the incremental cost per QALY gained increased to almost £1.5 million. In the probabilistic sensitivity analysis, the incremental costs per QALY gained were below £20,000 in 39 % of the 5000 simulations.Conclusions: Give it a Go did not significantly increase life-expectancy, but had a positive influence on quality of life due to the mental health gain of physical activity. If the increase in physical activity caused by Give it a Go lasts for more than 1 year, the programme would be cost-effective given a willingness to pay for a QALY of £20,000. [ABSTRACT FROM AUTHOR]

Background: The prevalence of infant obesity is increasing, but there is a lack of evidence-based approaches to prevent obesity at this age. This study tested the acceptability and feasibility of evaluating a theory-based intervention aimed at reducing risk of obesity in infants of overweight/obese women during and after pregnancy: the Healthy and Active Parenting Programme for Early Years (HAPPY).Methods: A feasibility randomised controlled trial was conducted in Bradford, England. One hundred twenty overweight/obese pregnant women (Body Mass Index [BMI] ≥25 kg/m(2)) were recruited between 10-26 weeks gestation. Consenting women were randomly allocated to HAPPY (6 antenatal, 6 postnatal sessions: N = 59) or usual care (N = 61). Appropriate outcome measures for a full trial were explored, including: infant's length and weight, woman's BMI, physical activity and dietary intake of the women and infants. Health economic data were collected. Measurement occurred before randomisation and when the infant was aged 6 months and 12 months. Feasibility outcomes were: recruitment/attrition rates, and acceptability of: randomisation, measurement, and intervention. Intra-class correlations for infant weight were calculated. Fidelity was assessed through observations and facilitator feedback. Focus groups and semi-structured interviews explored acceptability of methods, implementation, and intervention content.Results: Recruitment targets were met (~20 women/month) with a recruitment rate of 30 % of eligible women (120/396). There was 30 % attrition at 12 months; 66 % of recruited women failed to attend intervention sessions, but those who attended the first session were likely to continue to attend (mean 9.4/12 sessions, range 1-12). Reaction to intervention content was positive, and fidelity was high. Group clustering was minimal; an adjusted effect size of -0.25 standard deviation scores for infant weight at 12 months (95 % CI: -0.16-0.65) favouring the intervention was observed using intention to treat analyses. No adverse events were reported.Conclusions: The HAPPY intervention appeared feasible and acceptable to participants who attended and those delivering it, however attendance was low; adaptations to increase initial attendance are recommended. Whilst the study was not powered to detect a definitive effect, our results suggest a potential to reduce risk of infant obesity. The evidence reported provides valuable lessons to inform progression to a definitive trial.Trial Registration: Current Controlled Trials ISRCTN56735429. [ABSTRACT FROM AUTHOR]

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. [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]

Background: The morbidity of gay, lesbian or bisexual people attending family practice has not been previously assessed. We compared health measures of family practice attendees classified as lesbian, gay and bisexual. Methods: We conducted a cross-sectional, controlled study conducted in 13 London family practices and compared the responses of 26 lesbian and 85 bisexual classified women, with that of 934 heterosexual classified women and 38 gay and 23 bisexual classified men with that of 373 heterosexual classified men. Our outcomes of interest were: General health questionnaire; CAGE questionnaire; short form12; smoking status; sexual experiences during childhood; number of sexual partners and sexual function and satisfaction. Results: In comparison to people classified as heterosexuals: men classified as gay reported higher levels of psychological symptoms (OR 2.48, CI 1.05-5.90); women classified as bisexual were more likely to misuse alcohol (OR 2.73, 1.70-4.40); women classified as bisexual (OR 2.53, 1.60-4.00) and lesbian (OR 3.13, 1.41-6.97) and men classified as bisexual (OR 2.48, 1,04, 5.86) were more likely to be smokers and women classified as bisexual (OR 3.27, 1.97-5.43) and men classified as gay (OR 4.86, 2.28-10.34) were much more likely to report childhood sexual experiences in childhood. Psychological distress was associated with reporting sexual experiences in childhood in men classified as gay and bisexual and women classified as heterosexual. Men classified as bisexual (OR 5.00, 1.73-14.51) and women classified as bisexual (OR 2.88, 1.24- 6.56) were more likely than heterosexuals to report more than one sexual partner in the preceding four weeks. Lesbian, gay and bisexual classified people encountered no more sexual function problems than heterosexuals but men classified as bisexual (OR 2.74, 1.12-6.70) were more dissatisfied with their sex lives. Conclusion: Bisexual and lesbian classified people attending London general practices were more likely to be smokers and gay classified men were at increased risk of psychological distress in comparison to heterosexual classified people. Increased awareness of the sexuality of people seen in primary care can provide opportunities for health promotion. [ABSTRACT FROM AUTHOR]

Background: Increasing rates of sexually transmitted infections (STIs) in men-who-have-sex-with-men (MSM) in England is a pressing public health concern. Interventions targeting MSM, including information provision that effectively promotes sexual health, are needed. To support such intervention development, it is necessary to understand acceptable ways of delivering sexual health information. We explored the acceptability and potential uses and impacts of delivering sexual health information to MSM through social media and geosocial networking apps or dating apps.Methods: Semi-structured interviews were conducted in person or by telephone with 25 MSM resident in England recruited via dating apps and social media advertisements. Interviews explored sexual health information sources, perceptions and uses. Attitudes towards sexual health promotion through social media and dating apps were then discussed. The data were analysed using thematic analysis.Results: Sexual health information delivery through social media and dating apps was considered acceptable. Receiving information when browsing social media was viewed positively by most, as people have time to absorb information. In contrast, concerns were expressed that sharing or commenting on social media sexual health information may lead to judgements and discrimination. While social media reaches a high proportion of the population, dating apps can easily target MSM. However, tensions exist between the ability to provide information at an opportune time through dating apps, when users are connecting with new sexual partners, with the potential to adversely affect the app user's experience. Hypothetical and actual uses and impacts of sexual health information ranged from no impact to reading information, sharing with peers, and increased awareness, to influencing healthcare-seeking, decision-making and risk-taking behaviours. Ensuring that information is engaging, positive in tone, not too clinical, focused on building social norms and delivered by trusted organisations were viewed as important for supporting its use.Conclusions: Overall, these findings support the development of new interventions that use dating apps and social media for sexual health promotion. [ABSTRACT FROM AUTHOR]

Background: The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA. A feasibility randomised controlled trial was conducted in England to adapt the intervention to the UK context. An embedded process evaluation focused on three key questions. 1. Was it feasible and acceptable to implement the intervention as planned? 2. How did the intervention affect staff and parent mediators? 3. Were the trial design and methods acceptable?Methods: Twelve nurseries in south-west England were recruited and randomised to intervention or control. The intervention comprised: NAP SACC UK Partner (Health Visitor) support to nurseries to review practice and policies against best practice, and then set goals to improve physical activity, nutrition and oral health; two staff training workshops; and a web-based parent support element. The process evaluation comprised: observations of Partner training (n = 1), Partner/manager meetings (n = 5) and staff workshops (n = 10); semi-structured interviews with Partners (n = 4), managers (n = 12), staff (n = 4) and parents (n = 20); analysis of self-assessment forms, goal setting forms and Partner logbooks; and assessment of staff and parent knowledge, motivation and self-efficacy mediators.Results: Overall, NAP SACC UK was feasible to implement and acceptable to nursery staff, managers, Partners and parents. The intervention was implemented as planned in five of the six intervention nurseries. Partners and managers appreciated the opportunity to review and improve nursery practices and valued the relationship forged between them. Staff rated the training workshops highly, despite attending outside of working hours. Most goals set by nurseries were achieved. However, Partners raised concerns about Health Visitors' capacity to deliver the intervention in any subsequent roll out. Mediator scores improved in all but two areas in intervention staff and parents, with decreases or minimal changes in the control group. The web-based parent element was not well used and should be removed from any subsequent trial. The trial methods were acceptable to managers, staff, Partners and parents.Conclusions: Implementing and evaluating a physical activity and nutrition intervention in nursery settings is feasible and acceptable. A full RCT of NAP SACC UK (with appropriate modifications) is warranted.Trial Registration: ISRCTN16287377 (10 Apr 2015). [ABSTRACT FROM AUTHOR]

Background: Older people living in deprived areas, from black and minority ethnic groups (BME) or aged over 85 years (oldest old) are recognised as 'hard to reach'. Engaging these groups in health promotion is of particular importance when seeking to target those who may benefit the most and to reduce health inequalities. This study aimed to explore what influences them practicing health promotion and elicit the views of cross-sector professionals with experiences of working with 'hard to reach' older people, to help inform best practice on engagement.Methods: 'Hard to reach' older people were recruited through primary care by approaching those not attending for preventative healthcare, and via day centres. Nineteen participated in an interview (n = 15) or focus group (n = 4); including some overlaps: 17 were from a deprived area, 12 from BME groups, and five were oldest old. Cross-sector health promotion professionals across England with experience of health promotion with older people were identified through online searches and snowball sampling. A total of 31 of these 44 professionals completed an online survey including open questions on barriers and facilitators to uptake in these groups. Thematic analysis was used to develop a framework of higher and lower level themes. Interpretations were discussed and agreed within the team.Results: Older people's motivation to stay healthy and independent reflected their everyday behaviour including practicing activities to feel or stay well, level of social engagement, and enthusiasm for and belief in health promotion. All of the oldest old reported trying to live healthily, often facilitated by others, yet sometimes being restricted due to poor health. Most older people from BME groups reported a strong wish to remain independent which was often positively influenced by their social network. Older people living in deprived areas reported reluctance to undertake health promotion activities, conveyed apathy and reported little social interaction. Cross-sector health professionals consistently reported similar themes as the older people, reinforcing the views of the older people through examples.Conclusions: The study shows some shared themes across the three 'hard-to-reach' groups but also some distinct differences, suggesting that a carefully outlined strategy should be considered to reach successfully the group targeted. [ABSTRACT FROM AUTHOR]