Mental health support and training to improve secondary school teachers’ well-being: the WISE cluster RCT

Background Health and Safety Executive data show that teachers are at heightened risk of mental health difficulties, yet few studies have attempted to address this. Poor teacher mental health may impact on the quality of support provided to young people, who also report increased mental health difficulties themselves. Objective To test the effectiveness of an intervention aiming to improve secondary school teachers’ well-being through mental health support and training. Design A cluster randomised controlled trial with embedded process and economic evaluations. Setting Twenty-five mainstream, non-fee-paying secondary schools in the south-west of England and South Wales, stratified by geographical area and free school meal entitlement, randomly allocated to intervention or control groups following collection of baseline measures (n = 12, intervention; n = 13, control) between May and July 2016. Participants All teachers in the study schools at any data collection. All students in year 8 (baseline) and year 10 (final follow-up). Intervention Each intervention school received three elements: (1) a 1-day mental health first aid for schools and colleges training session delivered to 8% of all teachers; (2) a 1-hour mental health session delivered to all teachers; and (3) 8% of staff trained in the 2-day standard mental health first aid training course set up a confidential peer support service for colleagues. Control schools continued with usual practice. Main outcome measures The primary outcome was teacher well-being (using the Warwick–Edinburgh Mental Wellbeing Scale). Secondary outcomes were teacher depression, absence and presenteeism, and student well-being, mental health difficulties, attendance and attainment. Follow-up was at 12 and 24 months. Data were analysed using intention-to-treat mixed-effects repeated-measures models. Economic evaluation A cost–consequence analysis to compare the incremental cost of the intervention against the outcomes measured in the main analysis. Process evaluation A mixed-methods study (i.e. qualitative focus groups and interviews, quantitative surveys, checklists and logs) to examine intervention implementation, activation of the mechanisms of change outlined in the logic model, intervention acceptability and the wider context. Results All 25 schools remained in the study. A total of 1722 teachers were included in the primary analysis. We found no difference in mean teacher well-being between study arms over the course of follow-up (adjusted mean difference –0.90, 95% confidence interval –2.07 to 0.27). There was also no difference in any of the secondary outcomes (p-values 0.203–0.964 in the fully adjusted models). The average cost of the intervention was £9103 (range £5378.97–12,026.73) per intervention school, with the average cost to Welsh schools being higher because of a different delivery model. The training components were delivered with high fidelity, although target dosage was sometimes missed. The peer support service was delivered with variable fidelity, and reported usage by teachers was low (5.9–6.1%). The intervention had high acceptability, but participants reported low support from senior leadership, and minimal impact on school culture. Limitations Participants and the study team were unblinded, self-report for the main outcome measures and inaccurate measurement of peer support service usage. Conclusions The Wellbeing in Secondary Education (WISE) intervention was not effective at improving teacher or student well-being, or reducing mental health difficulties, possibly because of contextual barriers preventing it becoming embedded in school life. Future work Identification of ways in which to achieve system-level change and sustained support from senior leaders is important for future school-based mental health interventions. Trial registration Current Controlled Trials ISRCTN95909211. Funding This project was funded by the National Institute for Health Research Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 12. See the NIHR Journals Library website for further project information. Intervention costs were met by Public Health Wales, Public Health England and Bristol City Council.

One-to-one volunteer befriending to reduce symptoms of depression in people with intellectual disability: a feasibility RCT

Background Little is known about the effectiveness of befriending for people with intellectual disability and whether or not befriending improves depressive symptoms and social outcomes. Objective This pilot trial aimed to assess the feasibility and acceptability of conducting a future full-scale randomised controlled trial of one-to-one befriending for people with intellectual disability who had depressive symptoms. Design This was a parallel-group, two-armed randomised controlled trial incorporating an exploratory economic analysis and a mixed-methods process evaluation. Outcome assessments were conducted at baseline and at 6 months post randomisation by a research assistant who was blind to allocation. We aimed to approach 50 participants, with a view to recruiting 40. Setting Participants with intellectual disability were recruited from one NHS trust and from referrals to two community befriending services. The intervention was delivered by community befriending services. Participants Adults with mild or moderate intellectual disability with a score on the Glasgow Depression Scale for people with a Learning Disability of ≥ 5 were included. Those attending a day service/college for ≥ 3 days a week were excluded. Volunteers were aged ≥ 18 years and had no history of prior convictions. Intervention Participants in the intervention group were matched with a volunteer befriender and were expected to meet once per week for 1 hour, over 6 months. Volunteers recorded activities in a logbook. Volunteers received training and regular supervision. Both groups received usual care and a resource booklet of local activities. Main outcome measures The feasibility outcomes and progression criteria were recruitment of at least 70% of participants approached; matching of at least 70% of participants in the intervention group to a volunteer; a dropout rate of < 30% of participants and volunteers; adherence to the intervention (10 meetings between pairs); acceptability of the intervention; and feasibility of collecting data on costs and resource use for an economic evaluation. Changes in depressive symptoms (primary clinical outcome: Glasgow Depression Scale) and self-esteem, quality of life, social participation, social support, health-related quality of life and service use were recorded at 6 months. Outcomes in volunteers were also assessed. Results We recruited only 16 participants with intellectual disability (40% of target) and 10 volunteers. Six of the eight (75%) participants in the intervention group were matched with a befriender and there was good adherence (mean number of meetings attended 11.8; range 1–21 meetings). Going to a cafe/restaurant and having a conversation were the most frequent activities. All participants were retained at follow-up, but two volunteers dropped out. Trial procedures and the intervention might be acceptable, but modifications were suggested. Data on costs and resource use were obtained, but there were discrepancies in the health-related quality-of-life data. Limitations Delays to the study prevented the use of alternative recruitment strategies and the planned 12-month follow-up could not be completed. Conclusions Recruitment was not feasible, but other feasibility outcomes were more positive. Future work Evaluating befriending for people with intellectual disability could be explored through alternative study designs, such as observational studies. Trial registration Current Controlled Trials ISRCTN63779614. 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. 9, No. 10. See the NIHR Journals Library website for further project information.

Intended and unintended consequences of the implementation of minimum unit pricing of alcohol in Scotland: a natural experiment

Background Scotland was the first country to implement minimum unit pricing for alcohol nationally. Minimum unit pricing aims to reduce alcohol-related harms and to narrow health inequalities. Minimum unit pricing sets a minimum retail price based on alcohol content, targeting products preferentially consumed by high-risk drinkers. This study comprised three components. Objectives This study comprised three components assessing alcohol consumption and alcohol-related attendances in emergency departments, investigating potential unintended effects of minimum unit pricing on alcohol source and drug use, and exploring changes in public attitudes, experiences and norms towards minimum unit pricing and alcohol use. Design We conducted a natural experiment study using repeated cross-sectional surveys comparing Scotland (intervention) and North England (control) areas. This involved comparing changes in Scotland following the introduction of minimum unit pricing with changes seen in the north of England over the same period. Difference-in-difference analyses compared intervention and control areas. Focus groups with young people and heavy drinkers, and interviews with professional stakeholders before and after minimum unit pricing implementation in Scotland allowed exploration of attitudes, experiences and behaviours, stakeholder perceptions and potential mechanisms of effect. Setting Four emergency departments in Scotland and North England (component 1), six sexual health clinics in Scotland and North England (component 2), and focus groups and interviews in Scotland (component 3). Participants Research nurses interviewed 23,455 adults in emergency departments, and 15,218 participants self-completed questionnaires in sexual health clinics. We interviewed 30 stakeholders and 105 individuals participated in focus groups. Intervention Minimum unit pricing sets a minimum retail price based on alcohol content, targeting products preferentially consumed by high-risk drinkers. Results The odds ratio for an alcohol-related emergency department attendance following minimum unit pricing was 1.14 (95% confidence interval 0.90 to 1.44; p = 0.272). In absolute terms, we estimated that minimum unit pricing was associated with 258 more alcohol-related emergency department visits (95% confidence interval –191 to 707) across Scotland than would have been the case had minimum unit pricing not been implemented. The odds ratio for illicit drug consumption following minimum unit pricing was 1.04 (95% confidence interval 0.88 to 1.24; p = 0.612). Concerns about harms, including crime and the use of other sources of alcohol, were generally not realised. Stakeholders and the public generally did not perceive price increases or changed consumption. A lack of understanding of the policy may have caused concerns about harms to dependent drinkers among participants from more deprived areas. Limitations The short interval between policy announcement and implementation left limited time for pre-intervention data collection. Conclusions Within the emergency departments, there was no evidence of a beneficial impact of minimum unit pricing. Implementation appeared to have been successful and there was no evidence of substitution from alcohol consumption to other drugs. Drinkers and stakeholders largely reported not noticing any change in price or consumption. The lack of effect observed in these settings in the short term, and the problem-free implementation, suggests that the price per unit set (£0.50) was acceptable, but may be too low. Our evaluation, which itself contains multiple components, is part of a wider programme co-ordinated by Public Health Scotland and the results should be understood in this wider context. Future work Repeated evaluation of similar policies in different contexts with varying prices would enable a fuller picture of the relationship between price and impacts. Trial registration Current Controlled Trials ISRCTN16039407. 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. 9, No. 11. See the NIHR Journals Library website for further project information.

An online family-based self-monitoring and goal-setting intervention to improve children’s physical activity: the FRESH feasibility trial and three-arm pilot RCT

Background Family-based physical activity promotion presents a promising avenue for promoting whole-family physical activity, but high-quality research is lacking. Objectives To assess the feasibility, acceptability and preliminary effectiveness of FRESH (Families Reporting Every Step to Health), a child-led online family-based physical activity intervention; and to identify effective and resource-efficient family recruitment strategies. Design The project consisted of (1) a randomised feasibility trial, (2) a randomised controlled pilot trial and (3) a systematic review and Delphi study. Setting Norfolk/Suffolk counties, UK. Participants Families, recruited from schools, workplaces and community settings, were eligible to participate if one child aged 7–11 years and one adult responsible for their care provided written consent; all family members could participate. Interventions The FRESH intervention, guided by self-determination theory, targeted whole families and was delivered via an online platform. All family members received pedometers and were given website access to select family step challenges to ‘travel’ to target cities around the world, log steps, and track progress as they virtually globetrotted. Families were randomised to FRESH intervention, pedometer-only or control arm. Main outcome measures Physical (e.g. blood pressure), psychosocial (e.g. family functioning) and behavioural (e.g. device-measured family physical activity) measures were collected at baseline and at 8- and 52-week follow-up. A mixed-methods process evaluation assessed the acceptability of the intervention and evaluation. Data sources review Systematic search of four databases (Cochrane Library, PubMed, PsycINFO and SCOPUS). Review methods Articles were screened in duplicate, and data extraction was fully checked. Academic experts participated in the three-round Delphi study. Data were combined to identify effective and resource-efficient family recruitment strategies. Inclusion criteria Included generally healthy school-aged children and at least one adult; intervention attempted to change physical activity, sedentary behaviour, screen use, diet, or prevent overweight/obesity in multiple family members; presented relevant measure of effect in children and adults. Results The feasibility study (12 families, 32 participants; 100% retention at 8 weeks) demonstrated the feasibility and acceptability of FRESH, but highlighted that adaptations were required. Of 41 families recruited in the pilot study (149 participants), 98% and 88% were retained at the 8-week and 52-week follow-up, respectively. More children in the FRESH arm self-reported doing more family physical activity, and they thought that FRESH was fun. There were no notable between-group differences in children’s outcomes. Change in moderate to vigorous physical activity at 8 weeks favoured FRESH intervention adults [vs. control: 9.4 minutes/week (95% confidence interval 0.4 to 18.4) vs. pedometer only: 15.3 (95% confidence interval 6.0 to 24.5)], and was stronger in fathers, but this was not maintained. In 49 included studies, apart from recruitment settings and strategies used (reported in 84% and 73% of the studies, respectively), recruitment details were scarce. School-based recruitment was predominant. The Delphi study identified a wide range of recruitment settings and strategies. Limitations Recruitment was the main limitation of the FRESH studies; generalisability of the proposed recruitment strategies may be limited. Conclusions This study has demonstrated the feasibility and acceptability of the FRESH intervention. However, we failed to recruit the target sample size and were unable to demonstrate a signal of effectiveness. Future research should employ a multifaceted recruitment approach. Future work Further refinements to intervention delivery and recruitment methods should be investigated. Study registration Current Controlled Trials ISRCTN12789422 and PROSPERO CRD42019140042. 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. 9, No. 9. See the NIHR Journals Library website for further project information.

School-based interventions to prevent anxiety, depression and conduct disorder in children and young people: a systematic review and network meta-analysis

Background Schools in the UK increasingly have to respond to anxiety, depression and conduct disorder as key causes of morbidity in children and young people. Objective The objective was to assess the comparative effectiveness of educational setting-based interventions for the prevention of anxiety, depression and conduct disorder in children and young people. Design This study comprised a systematic review, a network meta-analysis and an economic evaluation. Data sources The databases MEDLINE, EMBASE™ (Elsevier, Amsterdam, the Netherlands), PsycInfo® (American Psychological Association, Washington, DC, USA) and Cochrane Central Register of Controlled Trials (CENTRAL) were searched to 4 April 2018, and the NHS Economic Evaluation Database (NHS EED) was searched on 22 May 2019 for economic evaluations. No language or date filters were applied. Main outcomes The main outcomes were post-intervention self-reported anxiety, depression or conduct disorder symptoms. Review methods Randomised/quasi-randomised trials of universal or targeted interventions for the prevention of anxiety, depression or conduct disorder in children and young people aged 4–18 years were included. Screening was conducted independently by two reviewers. Data extraction was conducted by one reviewer and checked by a second. Intervention- and component-level network meta-analyses were conducted in OpenBUGS. A review of the economic literature and a cost–consequence analysis were conducted. Results A total of 142 studies were included in the review, and 109 contributed to the network meta-analysis. Of the 109 studies, 57 were rated as having an unclear risk of bias for random sequence generation and allocation concealment. Heterogeneity was moderate. In universal secondary school settings, mindfulness/relaxation interventions [standardised mean difference (SMD) –0.65, 95% credible interval (CrI) –1.14 to –0.19] and cognitive–behavioural interventions (SMD –0.15, 95% CrI –0.34 to 0.04) may be effective for anxiety. Cognitive–behavioural interventions incorporating a psychoeducation component may be effective (SMD –0.30, 95% CrI –0.59 to –0.01) at preventing anxiety immediately post intervention. There was evidence that exercise was effective in preventing anxiety in targeted secondary school settings (SMD –0.47, 95% CrI –0.86 to –0.09). There was weak evidence that cognitive–behavioural interventions may prevent anxiety in universal (SMD –0.07, 95% CrI –0.23 to 0.05) and targeted (SMD –0.38, 95% CrI –0.84 to 0.07) primary school settings. There was weak evidence that cognitive–behavioural (SMD –0.04, 95% CrI –0.16 to 0.07) and cognitive–behavioural + interpersonal therapy (SMD –0.18, 95% CrI –0.46 to 0.08) may be effective in preventing depression in universal secondary school settings. Third-wave (SMD –0.35, 95% CrI –0.70 to 0.00) and cognitive–behavioural interventions (SMD –0.11, 95% CrI –0.28 to 0.05) incorporating a psychoeducation component may be effective at preventing depression immediately post intervention. There was no evidence of intervention effectiveness in targeted secondary, targeted primary or universal primary school settings post intervention. The results for university settings were unreliable because of inconsistency in the network meta-analysis. A narrative summary was reported for five conduct disorder prevention studies, all in primary school settings. None reported the primary outcome at the primary post-intervention time point. The economic evidence review reported heterogeneous findings from six studies. Taking the perspective of a single school budget and based on cognitive–behavioural therapy intervention costs in universal secondary school settings, the cost–consequence analysis estimated an intervention cost of £43 per student. Limitations The emphasis on disorder-specific prevention excluded broader mental health interventions and restricted the number of eligible conduct disorder prevention studies. Restricting the study to interventions delivered in the educational setting may have limited the number of eligible university-level interventions. Conclusions There was weak evidence of the effectiveness of school-based, disorder-specific prevention interventions, although effects were modest and the evidence not robust. Cognitive–behavioural therapy-based interventions may be more effective if they include a psychoeducation component. Future work Future trials for prevention of anxiety and depression should evaluate cognitive–behavioural interventions with and without a psychoeducation component, and include mindfulness/relaxation or exercise comparators, with sufficient follow-up. Cost implications must be adequately measured. Study registration This study is registered as PROSPERO CRD42016048184. 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. 9, No. 8. See the NIHR Journals Library website for further project information.

Exploring the uptake and use of electronic cigarettes provided to smokers accessing homeless centres: a four-centre cluster feasibility trial

Background Smoking prevalence is extremely high in adults experiencing homelessness, and there is little evidence regarding which cessation interventions work best. This study explored the feasibility of providing free electronic cigarette starter kits to smokers accessing homeless centres in the UK. Objectives Seven key objectives were examined to inform a future trial: (1) assess willingness of smokers to participate in the study to estimate recruitment rates; (2) assess participant retention in the intervention and control arms; (3) examine the perceived value of the intervention, facilitators of and barriers to engagement, and influence of local context; (4) assess service providers’ capacity to support the study and the type of information and training required; (5) assess the potential efficacy of supplying free electronic cigarette starter kits; (6) explore the feasibility of collecting data on contacts with health-care services as an input to a main economic evaluation; and (7) estimate the cost of providing the intervention and usual care. Design A prospective cohort four-centre pragmatic cluster feasibility study with embedded qualitative process evaluation. Setting Four homeless centres. Two residential units in London, England. One day centre in Northampton, England. One day centre in Edinburgh, Scotland. Intervention In the intervention arm, a single refillable electronic cigarette was provided together with e-liquid, which was provided once per week for 4 weeks (choice of three flavours: fruit, menthol or tobacco; two nicotine strengths: 12 or 18 mg/ml). There was written information on electronic cigarette use and support. In the usual-care arm, written information on quitting smoking (adapted from NHS Choices) and signposting to the local stop smoking service were provided. Results Fifty-two per cent of eligible participants invited to take part in the study were successfully recruited (56% in the electronic cigarette arm; 50.5% in the usual-care arm; total n = 80). Retention rates were 75%, 63% and 59% at 4, 12 and 24 weeks, respectively. The qualitative component found that perceived value of the intervention was high. Barriers were participants’ personal difficulties and cannabis use. Facilitators were participants’ desire to change, free electronic cigarettes and social dynamics. Staff capacity to support the study was generally good. Carbon monoxide-validated sustained abstinence rates at 24 weeks were 6.25% (3/48) in the electronic cigarette arm compared with 0% (0/32) in the usual-care arm (intention to treat). Almost all participants present at follow-up visits completed measures needed for input into an economic evaluation, although information about staff time to support usual care could not be gathered. The cost of providing the electronic cigarette intervention was estimated at £114.42 per person. An estimated cost could not be calculated for usual care. Limitations Clusters could not be fully randomised because of a lack of centre readiness. The originally specified recruitment target was not achieved and recruitment was particularly difficult in residential centres. Blinding was not possible for the measurement of outcomes. Staff time supporting usual care could not be collected. Conclusions The study was associated with reasonable recruitment and retention rates and promising acceptability in the electronic cigarette arm. Data required for full cost-effectiveness evaluation in the electronic cigarette arm could be collected, but some data were not available in the usual-care arm. Future work Future research should focus on several key issues to help design optimal studies and interventions with this population, including which types of centres the intervention works best in, how best to retain participants in the study, how to help staff to deliver the intervention, and how best to record staff treatment time given the demands on their time. Trial registration Current Controlled Trials ISRCTN14140672; the protocol was registered as researchregistry4346. 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. 9, No. 7. See the NIHR Journals Library website for further project information.

A digital behaviour change intervention to increase booking and attendance at Stop Smoking Services: the MyWay feasibility RCT

Background Smoking remains a leading cause of illness and preventable death. NHS Stop Smoking Services increase quitting, but, as access is in decline, cost-effective interventions are needed that promote these services. StopApp™ (Coventry University, Coventry, UK) is designed to increase booking and attendance at Stop Smoking Services. Design A two-arm feasibility randomised controlled trial of StopApp (intervention) compared with standard promotion and referral to Stop Smoking Services (control) was conducted to assess recruitment, attrition and health equity of the design, alongside health economic and qualitative process evaluations. Setting Smokers recruited via general practitioners, community settings and social media. Participants Smokers aged ≥ 16 years were recruited in one local authority. Participants had to live or work within the local authority area, and there was a recruitment target of 120 participants. Interventions StopApp to increase booking and attendance at Stop Smoking Services. Main outcome measures Participants completed baseline measures and follow-up at 2 months post randomisation entirely online. Objective data on the use of Stop Smoking Services were collected from participating Stop Smoking Services, and age groups, sex, ethnicity and socioeconomic status in baseline recruits and follow-up completers/non-completers were assessed for equity. Results Eligible participants (n = 123) were recruited over 116 days, with good representation of lower socioeconomic status groups; black, Asian and minority ethnic groups; and all age groups. Demographic profiles of follow-up completers and non-completers were broadly similar. The attrition rate was 51.2%, with loss to follow-up lowest in the social media setting (n = 24/61; 39.3%) and highest in the general practitioner setting (n = 21/26; 80.8%). Most measures had < 5% missing data. Social media represented the most effective and cost-efficient recruitment method. In a future, definitive, multisite trial with recruitment driven by social media, our data suggest that recruiting ≥ 1500 smokers over 12 months is feasible. Service data showed that five bookings for the Stop Smoking Services were scheduled using StopApp, of which two did not attend. Challenges with data access were identified. A further five participants in the intervention arm self-reported booking and accessing Stop Smoking Services outside StopApp compared with two control arm participants. Event rate calculations for the intervention were 8% (Stop Smoking Services data), 17% (including self-reports) and 3.5% from control arm self-reports. A conservative effect size of 6% is estimated for a definitive full trial. A sample size of 840 participants would be required to detect an effect for the primary outcome measure of booking a Stop Smoking Services appointment in a full randomised controlled trial. The process evaluation found that participants were satisfied with the research team contact, study methods and provision of e-vouchers. Staff interviews revealed positive and negative experiences of the trial and suggestions for improvements, including encouraging smokers to take part. Conclusion This feasibility randomised controlled trial found that, with recruitment driven wholly or mainly by social media, it is possible to recruit and retain sufficient smokers to assess the effectiveness and cost-effectiveness of StopApp. The study methods and measures were found to be acceptable and equitable, but accessing Stop Smoking Services data about booking, attendance and quit dates was a challenge. A full trial may be feasible if service data are accessible. This will require careful planning with data controllers and a targeted social media campaign for recruitment. Changes to some study measures are needed to avoid missing data, including implementation of a more intensive follow-up data collection process. Future work We plan a full, definitive randomised controlled trial if the concerns around data access can be resolved, with adaptations to the recruitment and retention strategy. Limitations Our trial had high attrition and problems with collecting Stop Smoking Services data, which resulted in a reliance on self-reporting. Trial registration Research Registry: 3995. The trial was registered on 18 April 2018. 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. 9, No. 5. See the NIHR Journals Library website for further project information.

A school-based, peer-led programme to increase physical activity among 13- to 14-year-old adolescents: the GoActive cluster RCT

Background Adolescent physical activity levels are low and are associated with rising disease risk and social disadvantage. The Get Others Active (GoActive) intervention was co-designed with adolescents and teachers to increase physical activity in adolescents. Objective To assess the effectiveness and cost-effectiveness of the school-based GoActive programme in increasing adolescents’ moderate-to-vigorous physical activity. Design A cluster randomised controlled trial with an embedded mixed-methods process evaluation. Setting Non-fee-paying schools in Cambridgeshire and Essex, UK (n = 16). Schools were computer randomised and stratified by socioeconomic position and county. Participants A total of 2862 Year 9 students (aged 13–14 years; 84% of eligible students). Intervention The iteratively developed feasibility-tested refined 12-week intervention trained older adolescents (mentors) and in-class peer leaders to encourage classes to undertake two new weekly activities. Mentors met with classes weekly. Students and classes gained points and rewards for activity in and out of school. Main outcome measures The primary outcome was average daily minutes of accelerometer-assessed moderate-to-vigorous physical activity at 10 months post intervention. Secondary outcomes included accelerometer-assessed activity during school, after school and at weekends; self-reported physical activity and psychosocial outcomes; cost-effectiveness; well-being and a mixed-methods process evaluation. Measurement staff were blinded to allocation. Results Of 2862 recruited participants, 2167 (76%) attended 10-month follow-up measurements and we analysed the primary outcome for 1874 (65.5%) participants. At 10 months, there was a mean decrease in moderate-to-vigorous physical activity of 8.3 (standard deviation 19.3) minutes in control participants and 10.4 (standard deviation 22.7) minutes in intervention participants (baseline-adjusted difference –1.91 minutes, 95% confidence interval –5.53 to 1.70 minutes; p = 0.316). The programme cost £13 per student compared with control. Therefore, it was not cost-effective. Non-significant indications of differential impacts suggested detrimental effects among boys (boys –3.44, 95% confidence interval –7.42 to 0.54; girls –0.20, 95% confidence interval –3.56 to 3.16), but favoured adolescents from lower socioeconomic backgrounds (medium/low 4.25, 95% confidence interval –0.66 to 9.16; high –2.72, 95% confidence interval –6.33 to 0.89). Mediation analysis did not support the use of any included intervention components to increase physical activity. Some may have potential for improving well-being. Students, teachers and mentors mostly reported enjoying the GoActive intervention (56%, 87% and 50%, respectively), but struggled to conceptualise their roles. Facilitators of implementation included school support, embedding a routine, and mentor and tutor support. Challenges to implementation included having limited school space for activities, time, and uncertainty of teacher and mentor roles. Limitations Retention on the primary outcome at 10-month follow-up was low (65.5%), but we achieved our intended sample size, with retention comparable to similar trials. Conclusions A rigorously developed school-based intervention (i.e. GoActive) was not effective in countering the age-related decline in adolescent physical activity. Overall, this mixed-methods evaluation provides transferable insights for future intervention development, implementation and evaluation. Future work Interdisciplinary research is required to understand educational setting-specific implementation challenges. School leaders and authorities should be realistic about expectations of the effect of school-based physical activity promotion strategies implemented at scale. Trial registration Current Controlled Trials ISRCTN31583496. 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. 9, No. 6. See the NIHR Journals Library website for further project information. This work was additionally supported by the Medical Research Council (London, UK) (Unit Programme number MC_UU_12015/7) and undertaken under the auspices of the Centre for Diet and Activity Research (Cambridge, UK), a UK Clinical Research Collaboration Public Health Research Centre of Excellence. Funding from the British Heart Foundation (London, UK), Cancer Research UK (London, UK), Economic and Social Research Council (Swindon, UK), Medical Research Council, the National Institute for Health Research (Southampton, UK) and the Wellcome Trust (London, UK), under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged (087636/Z/08/Z; ES/G007462/1; MR/K023187/1). GoActive facilitator costs were borne by Essex and Cambridgeshire County Councils.

Potential effects of minimum unit pricing at local authority level on alcohol-attributed harms in North West and North East England: a modelling study

Background In 2018, Scotland implemented a 50p-per-unit minimum unit price for alcohol. Previous modelling estimated the impact of minimum unit pricing for England, Scotland, Wales and Northern Ireland. Decision-makers want to know the potential effects of minimum unit pricing for local authorities in England; the premise of this study is that estimated effects of minimum unit pricing would vary by locality. Objective The objective was to estimate the potential effects on mortality, hospitalisations and crime of the implementation of minimum unit pricing for alcohol at local authority level in England. Design This was an evidence synthesis, and used computer modelling using the Sheffield Alcohol Policy Model (local authority version 4.0). This study gathered evidence on local consumption of alcohol from the Health Survey for England, and gathered data on local prices paid from the Living Costs and Food Survey and from market research companies’ actual sales data. These data were linked with local harms in terms of both alcohol-attributable mortality (from the Office for National Statistics) and alcohol-attributable hospitalisations (from Hospital Episode Statistics) for 45 conditions defined by the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision. These data were examined for eight age–sex groups split by five Index of Multiple Deprivation quintiles. Alcohol-attributable crime data (Office for National Statistics police-recorded crimes and uplifts for unrecorded offences) were also analysed. Setting This study was set in 23 upper-tier local authorities in North West England, 12 upper-tier local authorities in the North East region and nine government office regions, and a national summary was conducted. Participants The participants were the population of England aged ≥ 18 years. Intervention The intervention was setting a local minimum unit price. The base case is 50p per unit of alcohol. Sensitivity analyses were undertaken using minimum unit prices of 30p, 40p, 60p and 70p per unit of alcohol. Main outcome measures The main outcome measures were changes in alcohol-attributable deaths, hospitalisations and crime. Savings in NHS costs, changes in alcohol purchasing and consumption, changes in revenue to off-trade and on-trade retailers and changes in the slope index of inequality between most and least deprived areas were also examined. Results The modelling has proved feasible at the upper-tier local authority level. The resulting estimates suggest that minimum unit pricing for alcohol at local authority level could be effective in reducing alcohol-attributable deaths, hospitalisations, NHS costs and crime. A 50p minimum unit price for alcohol at local authority level is estimated to reduce annual alcohol-related deaths in the North West region by 205, hospitalisations by 5956 (–5.5%) and crimes by 8528 (–2.5%). These estimated reductions are mostly due to the 5% of people drinking at high-risk levels (e.g. men drinking > 25 pints of beer or five bottles of wine per week, women drinking > 17 pints of beer or 3.5 bottles of wine per week, and who spend around £2500 per year currently on alcohol). Model estimates of impact are bigger in the North West and North East regions than nationally because, currently, more cheap alcohol is consumed in these regions and because there are more alcohol-related deaths and hospitalisations in these areas. A 30p minimum unit price has estimated effects that are ≈ 90% lower than those of a 50p minimum unit price, and a 40p minimum unit price has estimated effects that are ≈ 50% lower. Health inequalities are estimated to reduce with greater health gains in the deprived areas, where more cheap alcohol is purchased and where there are higher baseline harms. Limitations The approach requires synthesis of evidence from multiple sources on alcohol consumption; prices paid; and incidence of diseases, mortality and crime. Price elasticities used are from previous UK analysis of price responsiveness rather than specific to local areas. The study has not estimated ‘cross-border effects’, namely travelling to shops outside the region. Conclusions The modelling estimates suggest that minimum unit pricing for alcohol at local authority level would be an effective and well-targeted policy, reducing inequalities. Future work The Sheffield Alcohol Policy Model for Local Authorities framework could be further utilised to examine the local impact of national policies (e.g. tax changes) or local policies (e.g. licensing or identification and brief advice). As evidence emerges from the Scottish minimum unit price implementation, this will further inform estimates of impact in English localities. The methods used to estimate drinking and purchasing patterns in each local authority could also be used for other topics involving unhealthy products affecting public health, for example to estimate local smoking or high-fat, high-salt food consumption patterns. 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. 9, No. 4. See the NIHR Journals Library website for further project information.

Slip-resistant footwear to reduce slips among health-care workers: the SSHeW RCT

Background In Great Britain, 100,000 injuries due to slips, trips and falls on the level (as opposed to falls from a height, e.g. a ladder) occur in the workplace each year. They are the most common cause of non-fatal injury in the workplace, accounting for 30% of all those injuries reported to the Health and Safety Executive. Nearly 1 million working days are lost because of slips, trips and falls each year. Objectives To assess the clinical effectiveness and cost-effectiveness of 5-star, GRIP-rated, slip-resistant footwear in preventing slips in the workplace compared with usual footwear. Design A two-arm, multicentre, randomised controlled trial with an economic evaluation and qualitative study. Setting Seven NHS trusts in England. Participants NHS staff aged ≥ 18 years, working at least 22.5 hours per week in clinical, general or catering areas who owned a mobile phone. Staff required to wear protective footwear were excluded. Interventions Intervention participants were offered 5-star, GRIP-rated, slip-resistant footwear. The waiting list control group were asked to wear their usual work shoes for the duration of the study and were offered the trial footwear at the end of their participation. Main outcome measures The primary outcome was the incidence rate of self-reported slips in the workplace over 14 weeks. Secondary outcomes included the incidence rate of falls either resulting from a slip or not resulting from a slip, proportion of participants reporting a slip, fall or fracture, time to first slip and fall, health-related quality of life and cost-effectiveness. Results A total of 4553 eligible NHS staff were randomised (2275 to the intervention arm and 2278 to the control arm). In total, 6743 slips were reported [2633 in the intervention group (mean 1.16 per participant, range 0–36 per participant) and 4110 in the control group (mean 1.80 per participant, range 0–83 per participant)]. There was a statistically significant reduction in the slip rate in the intervention group relative to the control group (incidence rate ratio 0.63, 95% confidence interval 0.57 to 0.70; p < 0.001). Statistically significant reductions were observed in falls from a slip (incidence rate ratio 0.51, 95% confidence interval 0.28 to 0.92; p = 0.03), the proportion of participants who reported a slip (odds ratio 0.58, 95% confidence interval 0.50 to 0.66; p < 0.001) or fall (odds ratio 0.73, 95% confidence interval 0.54 to 0.99; p = 0.04) and the time to first slip (hazard ratio 0.73, 95% confidence interval 0.67 to 0.80; p < 0.001). Half of the intervention participants wore the shoes all the time at work. Incremental cost per quality-adjusted life-year in the base case was £38,900 from the NHS perspective and –£60,400 (i.e. cost saving) from the societal perspective. Limitations This was an unblinded trial in which outcome data were participant self-reported, which may have led to inaccuracies in the reported slip data. Exposure to the trial footwear was lower than hoped. Conclusions The offer and provision of 5-star, GRIP-rated footwear reduced slips in the workplace, was acceptable to participants and could be cost-effective. Future work Replication of the study within other settings may be required to evaluate the clinical effectiveness and cost-effectiveness in other environments settings, such as catering and factories. Trial registration Current Controlled Trials ISRCTN33051393. 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. 9, No. 3. See the NIHR Public Journals Library website for further project information. The Health and Safety Executive provided some research costs.