Showing papers in "Public Health Research in 2019"

Mass media to communicate public health messages in six health topic areas: a systematic review and other reviews of the evidence

Abstract: Background Mass media campaigns can be used to communicate public health messages at the population level. Although previous research has shown that they can influence health behaviours in some contexts, there have been few attempts to synthesise evidence across multiple health behaviours. Objectives To (1) review evidence on the effective use of mass media in six health topic areas (alcohol, diet, illicit drugs, physical activity, sexual and reproductive health and tobacco), (2) examine whether or not effectiveness varies with different target populations, (3) identify characteristics of mass media campaigns associated with effectiveness and (4) identify key research gaps. Design The study comprised (1) a systematic review of reviews, (2) a review of primary studies examining alcohol mass media campaigns, (3) a review of cost-effectiveness evidence and (4) a review of recent primary studies of mass media campaigns conducted in the UK. A logic model was developed to inform the reviews. Public engagement activities were conducted with policy, practitioner and academic stakeholders and with young people. Results The amount and strength of evidence varies across the six topics, and there was little evidence regarding diet campaigns. There was moderate evidence that mass media campaigns can reduce sedentary behaviour and influence sexual health-related behaviours and treatment-seeking behaviours (e.g. use of smoking quitlines and sexual health services). The impact on tobacco use and physical activity was mixed, there was limited evidence of impact on alcohol use and there was no impact on illicit drug behaviours. Mass media campaigns were found to increase knowledge and awareness across several topics, and to influence intentions regarding physical activity and smoking. Tobacco and illicit drug campaigns appeared to be more effective for young people and children but there was no or inconsistent evidence regarding effectiveness by sex, ethnicity or socioeconomic status. There was moderate evidence that tobacco mass media campaigns are cost-effective, but there was weak or limited evidence in other topic areas. Although there was limited evidence on characteristics associated with effectiveness, longer or greater intensity campaigns were found to be more effective, and messages were important, with positive and negative messages and social norms messages affecting smoking behaviour. The evidence suggested that targeting messages to target audiences can be effective. There was little evidence regarding the role that theory or media channels may play in campaign effectiveness, and also limited evidence on new media. Limitations Statistical synthesis was not possible owing to considerable heterogeneity across reviews and studies. The focus on review-level evidence limited our ability to examine intervention characteristics in detail. Conclusions Overall, the evidence is mixed but suggests that (1) campaigns can reduce sedentary behaviour, improve sexual health and contribute to smoking cessation, (2) tobacco control campaigns can be cost-effective, (3) longer and more intensive campaigns are likely to be more effective and (4) message design and targeting campaigns to particular population groups can be effective. Future work Future work could fill evidence gaps regarding diet mass media campaigns and new-media campaigns, examine cost-effectiveness in areas other than tobacco and explore the specific contribution of mass media campaigns to multicomponent interventions and how local, regional and national campaigns can work together. Study registration This study is registered as PROSPERO CRD42015029205 and PROSPERO CRD42017054999. Funding The National Institute for Health Research Public Health Research programme.

Peer-led walking programme to increase physical activity in inactive 60- to 70-year-olds: Walk with Me pilot RCT

Abstract: Background Levels of physical activity decline with age. Some of the most disadvantaged individuals in society, such as those with a lower rather than a higher socioeconomic position, are also the most inactive. Peer-led physical activity interventions may offer a model to increase physical activity in these older adults and thus help reduce associated health inequalities. This study aims to develop and test the feasibility of a peer-led, multicomponent physical activity intervention in socioeconomically disadvantaged community-dwelling older adults. Objectives The study aimed to develop a peer-led intervention through a rapid review of previous peer-led interventions and interviews with members of the target population. A proposed protocol to evaluate its effectiveness was tested in a pilot randomised controlled trial (RCT). Design A rapid review of the literature and the pilot study informed the intervention design; a pilot RCT included a process evaluation of intervention delivery. Setting Socioeconomically disadvantaged communities in the South Eastern Health and Social Care Trust and the Northern Health and Social Care Trust in Northern Ireland. Participants Fifty adults aged 60–70 years, with low levels of physical activity, living in socioeconomically disadvantaged communities, recruited though community organisations and general practices. Interventions ‘Walk with Me’ is a 12-week peer-led walking intervention based on social cognitive theory. Participants met weekly with peer mentors. During the initial period (weeks 1–4), each intervention group participant wore a pedometer and set weekly step goals with their mentor’s support. During weeks 5–8 participants and mentors met regularly to walk and discuss step goals and barriers to increasing physical activity. In the final phase (weeks 9–12), participants and mentors continued to set step goals and planned activities to maintain their activity levels beyond the intervention period. The control group received only an information booklet on active ageing. Main outcome measures Rates of recruitment, retention of participants and completeness of the primary outcome [moderate- and vigorous-intensity physical activity measured using an ActiGraph GT3X+ accelerometer (ActiGraph, LLC, Pensacola, FL, USA) at baseline, 12 weeks (post intervention) and 6 months]; acceptability assessed through interviews with participants and mentors. Results The study planned to recruit 60 participants. In fact, 50 eligible individuals participated, of whom 66% (33/50) were female and 80% (40/50) were recruited from general practices. At 6 months, 86% (43/50) attended for review, 93% (40/43) of whom returned valid accelerometer data. Intervention fidelity was assessed by using weekly step diaries, which were completed by both mentors and participants for all 12 weeks, and checklists for the level of delivery of intervention components, which was high for the first 3 weeks (range 49–83%). However, the rate of return of checklists by both mentors and participants diminished thereafter. Outcome data indicate that a sample size of 214 is required for a definitive trial. Limitations The sample was predominantly female and somewhat active. Conclusions The ‘Walk with Me’ intervention is acceptable to a socioeconomically disadvantaged community of older adults and a definitive RCT to evaluate its effectiveness is feasible. Some modifications are required to ensure fidelity of intervention delivery is optimised. Future research needs to identify methods to recruit males and less active older adults into physical activity interventions.

Health impacts of environmental and social interventions designed to increase deprived communities' access to urban woodlands: a mixed-methods study

Abstract: Background Contact with natural environments can bring health benefits, but research is lacking on how changes in access to natural environments might improve health, especially for deprived populations. Objective To evaluate the health impacts of woodland environment interventions intended to increase communities’ engagement with these woodlands. Design A prospective study of Forestry Commission Scotland’s Woods In and Around Towns (WIAT) programme in deprived communities to enhance public access to natural environments. The study investigated the impact that WIAT had on community-level mental health over time. Setting Three intervention and three control woodland sites, and associated communities within 1.5 km of the woodlands, located in central Scotland and eligible for WIAT support. Participants A core community survey was administered at each site in three waves, at baseline and after each phase of intervention (n = 5460, panel A). The completed survey contained a nested longitudinal cohort (n = 609, panel B). Community members also undertook 6-monthly environmental audits at all sites (n = 256) and participated in post-intervention focus groups (n = 34). Interventions Phase 1 involved physical changes to the woodlands, including footpaths, entrances and vegetation. Phase 2 involved community engagement events promoting woodland use. Main outcome measures The primary outcome was the Perceived Stress Scale (PSS). Other health measures included health-related quality of life (HRQoL) EuroQol-5 Dimensions (EQ-5D), physical activity (PA) [International Physical Activity Questionnaire (IPAQ)], connectedness to nature [Inclusion of Nature in Self (INS) scale] and social cohesion. Results The PSS scores significantly increased in the intervention group and marginally decreased in the control group. Multilevel regression models showed a differential impact between the intervention and the control at survey wave 3 in panel A [B (unstandardised coefficient) 3.58, 95% confidence interval (CI) 2.85 to 4.31; p < 0.001] and in panel B [B 3.03, 95% CI 1.54 to 4.52; p < 0.001]. Using the same analytical approach, no significant change in HRQoL was associated with the intervention. Economic assessment included an illustrative cost–utility analysis and a cost–consequences analysis. The differential in stress between the intervention group and the control group was lower or non-significant in those who visited ‘nature’ in the previous year [panel A, B 1.9, 95% CI 0.8 to 3.0; p < 0.001; panel B, B 0.64, 95% CI –1.60 to 2.88; p = 0.57]. The IPAQ score showed a positive association with the intervention for moderate levels of PA [panel B, B 559.3, 95% CI 211.3 to 907.2; p = 0.002] and overall PA [panel B, B 861.5, 95% CI 106.5 to 1616.4; p = 0.025]. The intervention was also associated with increased nature connectedness and social cohesion by wave 3 – significant for panel A only. Qualitative and quantitative evidence showed that interventions increased the perceived quality of the woodland environment and enhanced its enjoyment for different activities, but the increase in use of natural environments post intervention was only 6% (panel B). Limitations This study was limited to three intervention sites. External factors may be the primary influence on health outcomes. Conclusions The WIAT interventions did not improve community-level health within 6 months of completion, and hence there was no basis for demonstrating cost-effectiveness. However, the WIAT interventions are low cost (average £11.80 per person in the eligible population) and have potential for cost-effectiveness, if health benefits were found in the longer term. Future work Using routinely collected data to consider a whole-programme evaluation is recommended. Funding The National Institute for Health Research Public Health Research programme.

A school-based intervention ('Girls Active') to increase physical activity levels among 11- to 14-year-old girls: cluster RCT

Abstract: Background Physical activity (PA) levels among adolescent girls in the UK are low. ‘Girls Active’, developed by the Youth Sport Trust (YST), has been designed to increase girls’ PA levels. Objective To understand the effectiveness and cost-effectiveness of the Girls Active programme. Design A two-arm cluster randomised controlled trial. Setting State secondary schools in the Midlands, UK. Participants Girls aged between 11 and 14 years. Intervention Girls Active involves teachers reviewing PA, sport and physical education provision, culture and practices in their school; attending training; creating action plans; and effectively working with girls as peer leaders to influence decision-making and to promote PA to their peers. Support from a hub school and the YST is offered. Main outcome measures The change in objectively measured moderate to vigorous intensity PA (MVPA) levels at 14 months. Secondary outcomes included changes in overall PA level (mean acceleration), light PA levels, sedentary time, body composition and psychosocial outcomes. Cost-effectiveness and process evaluation (qualitative and quantitative) data were collected. Results Twenty schools and 1752 pupils were recruited; 1211 participants provided complete primary outcome data at 14 months. No difference was found in mean MVPA level between groups at 14 months [1.7 minutes/day, 95% confidence interval (CI) –0.8 to 4.3 minutes/day], but there was a small difference in mean MVPA level at 7 months (2.4 minutes/day, 95% CI 0.1 to 4.7 minutes/day). Significant differences between groups were found at 7 months, but not at 14 months, in some of the objective secondary outcomes: overall PA level represented by average acceleration (1.39 mg, 95% CI 0.1 to 2.2 mg), after-school sedentary time (–4.7 minutes/day, 95% CI –8.9 to –0.6 minutes/day), overall light PA level (5.7 minutes/day, 95% CI 1.0 to 10.5 minutes/day) and light PA level on school days (4.5 minutes/day, 95% CI 0.25 to 8.75 minutes/day). Minor, yet statistically significant, differences in psychosocial measures at 7 months were found in favour of control schools. Significant differences in self-esteem and identified motivation in favour of intervention schools were found at 7 and 14 months, respectively. Subgroup analyses showed a significant effect of the intervention for those schools with higher numbers of pupils at 14 months. Girls Active was well received by teachers, and they reported that implemented strategies and activities were having a positive impact in schools. Barriers to implementation progress included lack of time, competing priorities and the programme flexibility. Implementation costs ranged from £2054 (£23/pupil) to £8545 (£95/pupil) per school. No differences were found between groups for health-related quality-of-life scores or frequencies, or for costs associated with general practitioner, school nurse and school counsellor use. Conclusions Girls Active may not have had an effect on the random 90 girls per school included in the evaluation. Although we included a diverse sample of schools, the results may not be generalisable to all schools. Girls Active was viewed positively but teachers did not implement as many aspects of the programme as they wanted. The intervention was unlikely to have a wide impact and did not have an impact on MVPA level at 14 months. Capitalising on the opportunities of a flexible programme like this, while also learning from the stated barriers to and challenges of long-term implementation that teachers face, is a priority for research and practice. Trial registration Current Controlled Trials ISRCTN10688342. 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. 7, No. 5. See the NIHR Journals Library website for further project information. The YST funded the intervention. This study was undertaken in collaboration with the Leicester Clinical Trials Unit, a UK Clinical Research Collaboration-registered clinical trials unit in receipt of NIHR Clinical Trials Unit support funding. Neither the YST nor the NIHR Clinical Trials Unit had any involvement in the Trial Steering Committee, data analysis, data interpretation, data collection or writing of the report. The University of Leicester authors are supported by the NIHR Leicester–Loughborough Biomedical Research Unit (2012–17), the NIHR Leicester Biomedical Research Centre (2017–22) and the Collaboration for Leadership in Applied Health Research and Care East Midlands. These funders had no involvement in the Trial Steering Committee, the data analysis, data interpretation, data collection or writing of the report.

Evidence for public health on novel psychoactive substance use: a mixed-methods study

Abstract: Background Novel psychoactive substances (NPSs) contribute to the public health impact of substance misuse. This report provides research evidence addressing 11 research questions related to NPSs, covering types, patterns and settings of use; supply sources; and implications for policy and practice. Methods The study used a conceptually linked three-phase mixed-methods design with a shared conceptual framework based on multiple-context risk and protective factors. Phase 1 was a quantitative phase involving secondary data analysis of the longitudinal Belfast Youth Development Study (BYDS), a latent class analysis using the 2039 BYDS participants. Phase 2 was an extensive qualitative analysis via narrative interviews with participants, sampled from BYDS, drug/alcohol services and prisons, to explore NPS use trajectories. Phase 3 was the final quantitative phase; generalisability of the shared risk factor part of the model was tested using the manual three-step approach to examine risk factors associated with latent class membership. The quantitative and qualitative analyses were integrated, thus allowing emerging findings to be further explored. Results The data suggest that NPSs have a place within a range of polydrug use trajectories. Models showed no distinctive NPS class, with no clear evidence of differential risks for NPS use compared with the use of other substances. From the qualitative analysis, a taxonomy of groups was derived that explored how and where NPSs featured in a range of trajectories. This taxonomy was used to structure the analysis of factors linked to use within a risk and protective framework. Drivers for use were considered alongside knowledge, perceptions and experience of harms. Suggestions about how interventions could best respond to the various patterns of use – with special consideration of synthetic cannabinoids (SCs), including how they relate to the use of heroin and the potential for NPSs to operate as a ‘snare’ to more problem use – were also presented. Limitations The study was conducted during 2016/17; generalisability beyond this sample and time point is limited. The level of missing data for some of the BYDS analysis was a limitation, as was the fact that the BYDS data were collected in 2011, so in a different context from the data collected during the narrative interviews. The Psychoactive Substances Act 2016 (Great Britain. Psychoactive Substances Act 2016. London: The Stationery Office; 2016) came into force during qualitative fieldwork and, although not particularly influential in this study, may be influential in future work. It is acknowledged that many of the data related to SCs and mephedrone. Although drug use was measured by self-report, the strength of rapport within interviews, reflective diaries and methodological acceptability checks helped to mitigate self-report bias. Conclusions NPSs continue to present significant challenges for legislation and monitoring, researching and developing interventions. Understanding of usage patterns remains poor, with most information based on populations and settings where problems have already occurred. This research contributes to the evidence base by providing much needed further empirical data on the lived experiences of NPS users across a range of settings. In the light of these data, implications for policy and practice are discussed. Future work Future research must generate improved epidemiological data on the extent, patterns and motivations for use longitudinally. The uniqueness of the information concerning SC use points to a specific set of findings not evidenced in other literature (e.g. intensity of SC withdrawal). Future research should focus on the symbiotic link between SC and heroin use. Funding The National Institute for Health Research Public Health Research programme.

Child-care self-assessment to improve physical activity, oral health and nutrition for 2- to 4-year-olds: a feasibility cluster RCT

Abstract: Background The Nutrition And Physical Activity Self Assessment for Child Care (NAP SACC) intervention has shown evidence of effectiveness in the USA but not been adapted or assessed for effectiveness in the UK. Objectives To evaluate the feasibility and acceptability of implementing NAP SACC in the UK. Design Adaptation and development of NAP SACC and feasibility cluster randomised controlled trial (RCT) including process and economic evaluations. Substudies assessed mediator questionnaire test–retest reliability and feasibility of food photography methods. Setting Nurseries, staff and parents in North Somerset, Cardiff, Gloucestershire and Bristol. Participants Development – 15 early years/public health staff and health visitors, 12 nursery managers and 31 parents. RCT – 12 nurseries and 31 staff, four partners and 168 children/parents. Mediator substudy – 82 parents and 69 nursery staff. Food photography substudy – four nurseries, 18 staff and 51 children. Intervention NAP SACC UK partners supported nurseries to review policies and practices and set goals to improve nutrition, oral health and physical activity (PA) over 5 months. Two workshops were delivered to nursery staff by local experts. A home component [website, short message service (SMS) and e-mails] supported parents. The control arm continued with usual practice. Main outcome measures Feasibility and acceptability of the intervention and methods according to prespecified criteria. Data sources Qualitative data to adapt the intervention. Measurements with children, parents and staff at baseline and post intervention (8–10 months after baseline). Interviews with nursery managers, staff, parents and NAP SACC UK partners; observations of training, workshops and meetings. Nursery environment observation, nursery Review and Reflect score, and resource log. Child height and weight, accelerometer-determined PA and sedentary time, screen time and dietary outcomes using the Child and Diet Evaluation Tool. Staff and parent questionnaires of knowledge, motivation and self-efficacy. Child quality of life and nursery, family and health-care costs. Food photography of everything consumed by individual children and staff questionnaire to assess acceptability. Results Thirty-two per cent (12/38) of nurseries and 35.3% (168/476) of children were recruited; no nurseries withdrew. The intervention was delivered in five out of six nurseries, with high levels of fidelity and acceptability. Partners found it feasible but had concerns about workload. The child loss to follow-up rate was 14.2%. There was suggestion of promise in intervention compared with control nurseries post intervention for snacks, screen time, proportion overweight or obese and accelerometer-measured total PA and moderate to vigorous PA. Many parental and nursery knowledge and motivation mediators improved. The average cost of delivering the intervention was £1184 per nursery excluding partner training, and the average cost per child was £27. Fourteen per cent of parents used the home component and the mediator questionnaire had good internal consistency and test–retest reliability. Photography of food was acceptable and feasible. Limitations Following nursery leavers was difficult. Accelerometer data, diet data and environmental assessment would have been more reliable with 2 days of data. Conclusions The NAP SACC UK intervention and methods were found to be feasible and acceptable to participants, except for the home component. There was sufficient suggestion of promise to justify a definitive trial. Future work A multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of NAP SACC UK has been funded by NIHR and will start in July 2019 (PHR NIHR 127551). Trial registration Current Controlled Trials ISRCTN16287377. 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. 7, No. 13. See the NIHR Journals Library website for further project information. Funding was also provided by the North Somerset and Gloucestershire Councils, Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer) (MR/KO232331/1), and the Elizabeth Blackwell Institute.

Interventions integrating health and academic education in schools to prevent substance misuse and violence: a systematic review

Abstract: Background Schools struggle to timetable health education. Interventions integrating academic and health education to reduce substance use and violence offer promise. No current systematic reviews examine such interventions. Objectives To review evidence to explore the following questions: (1) what types of interventions integrating health and academic education in schools serving those aged 4–18 years have been evaluated? (2) What theories of change inform these interventions? (3) What factors facilitate or limit the successful implementation and receipt of such interventions, and what are the implications for the delivery of such implementations in the UK? (4) How effective are such interventions in reducing smoking and violence and the use of alcohol and drugs, and at increasing attainment? Does this vary by students’ sociodemographic characteristics? (5) What factors appear to influence the effectiveness of such interventions? Data sources In total, 19 databases were searched from 18 November to 22 December 2015, updating searches for outcome evaluations for violence on 28 February 2018 and for substance use on 14 May 2018. References were extracted from included studies and authors contacted. Review methods Included studies reported on theories of change, and process or outcome evaluations of interventions that integrated academic and health education to reduce substance use and/or violence. References were screened on the title/abstract and then on the full report. Data extraction and appraisal used Cochrane, Evidence for Policy and Practice Information Centre and other established tools. Theories of change and process data were qualitatively synthesised. Outcome evaluations were synthesised narratively and meta-analytically. Results In total, 78,451 unique references were originally identified and 62 reports included. Search updates on 28 February and 14 May 2018 retrieved a further 2355 and 1945 references, respectively, resulting in the inclusion of six additional reports. Thirty-nine reports described theories, 16 reports (15 studies) evaluated process and 41 reports (16 studies) evaluated outcomes. Multicomponent interventions are theorised to erode ‘boundaries’ (strengthen relationships) between academic and health education, teachers and students, behaviour in classrooms and in the wider school, and schools and families. Teachers, pro-social peers and parents are theorised to act as role models and reinforcers of healthy behaviours learnt in lessons. There was clear evidence that interventions are facilitated by supportive senior management and alignment with the schools’ ethos, collaborative and supportive teaching environments, and positive pre-existing student, teacher and parent attitudes towards interventions. The barriers were overburdened teachers who had little time to both learn and implement integrated curricula. The strongest evidence for effectiveness was found for the reduction of substance use in school key stages (KSs) 2 and 3. For example, a meta-analysis for substance use at KS3 reported a mean difference of –0.09 (95% confidence interval –0.17 to –0.01). A meta-analysis for effectiveness in reducing violence victimisation in KS2 found no effect. There was mixed evidence for effects on academic outcomes, with meta-analysis precluded by methodological heterogeneity. Limitations Study quality was variable. Integration was sometimes not emphasised in theories of change. Conclusions These interventions are undertheorised but involve multiple forms of boundary erosion. There is clear evidence of characteristics affecting implementation. Interventions are likely to have the greatest impact on substance use. These programmes may be effective in reducing substance use but do not appear to reduce violence and findings on educational impacts are mixed. Future work Future evaluations should assess interventions with clearer theories of change and examine academic outcomes alongside violence and substance use outcomes. Study registration This study is registered as PROSPERO CRD42015026464. Funding The National Institute for Health Research Public Health Research programme.

Brief alcohol intervention for risky drinking in young people aged 14–15 years in secondary schools: the SIPS JR-HIGH RCT

Abstract: Background: Adverse effects from young people’s alcohol consumption manifest in a range of physical and psychosocial factors, including neurological issues, cognitive impairment and risk-taking behaviours. The SIPS JR-HIGH pilot trial showed alcohol screening and brief intervention (ASBI) to be acceptable to young people and schools in the north-east of England. Objectives: To conduct a two-arm, individually randomised controlled trial to evaluate the effectiveness and cost-effectiveness of ASBI for risky drinking in young people aged 14–15 years in the school setting, to monitor the fidelity of ASBI and to explore the barriers to, and facilitators of, implementation with staff, young people and parents. Design: A baseline survey with a 12-month follow-up. Interviews with 30 school staff, 21 learning mentors and nine teachers, and 33 young people and two parents. Setting: Thirty state schools in four areas of England: north-east, north-west, Kent and London. Participants: Year 10 school pupils who consented to the study (aged 14–15 years, recruited between November 2015 and June 2016), school-based staff and parents of the young people who took part in the study Interventions: Young people who screened positively on a single alcohol screening question andconsented were randomised to the intervention or control arm (blinded). The intervention was a 30-minute one-to-one structured brief intervention with a trained learning mentor and an alcohol leaflet. The control group received a healthy lifestyle leaflet (no alcohol information). Main outcome measures: The primary outcome measure was total alcohol consumed in the last 28 days. Secondary outcomes related to risky drinking, general psychological health, sexual risk-taking, energy drink consumption, age of first smoking, quality of life, quality-adjusted life-years, service utilisation and demographic information. Results: A total of 4523 young people completed the baseline survey, with 1064 screening positively (24%) and 443 being eligible to take part in the trial. Of those 443, 233 (53%) were randomised to the control arm and 210 were randomised to the intervention arm. Of the 443, 374 (84%) were successfully followed up at 12 months (intervention, n = 178; control, n = 196). The results were that the intervention showed no evidence of benefit for any alcohol-related measure when compared with the control arm. At 12 months we found a reduction from 61.9% to 43.3% using the Alcohol Use Disorders Identification Test cut-off point of 8 and cut-off point of 4 (69.0% to 60.7%). These results were not significant. A cost-effectiveness analysis showed that the average net cost saving of the brief intervention was £2865 (95% confidence interval –£11,272 to £2707) per year compared with usual practice, with the intervention showing a 76% probability of being cost saving compared with usual practice. The interview findings showed that school was an acceptable setting to carry out ASBI among staff and young people. Limitations: Recruitment of parents to take part in interviews was poor. Only 18 ASBI sessions were recorded, making it difficult to assess internal validity. Conclusions: Although the intervention was ineffective in reducing risky drinking in young people aged 14–15 years, it was well received by the young people and school staff who participated. Future work: Uniform reporting of the outcomes used for ASBI would generate more robust conclusions on the effectiveness of ASBI in the future. Pilot feasibility studies should include more than one geographical area. Future work on involving parents is needed.

The effect of the Winter Fuel Payment on household temperature and health: a regression discontinuity design study

Abstract: Background The Winter Fuel Payment (WFP) is a non-NHS population-level policy intervention that aims to reduce cold exposure and enhance the health and well-being of older adults. Labelling this cash transfer as ‘winter fuel’ has been shown to lead to increased household energy expenditure, but it is not known if this expenditure produces warmer homes or health benefits. Objectives First, the association between indoor temperature and health was established to identify the outcome measures most likely to be affected by the WFP. Then, whether or not receiving the WFP is associated with raised household temperature levels and/or improved health was assessed. Design Random and fixed effects regression models were used to estimate the link between ambient indoor temperature and health. A regression discontinuity (RD) design analysis exploiting the sharp eligibility criteria for the WFP was employed to estimate the potential impact of the payment. Setting The sample was drawn from the English Longitudinal Study of Ageing (ELSA), an observational study of community-dwelling individuals aged ≥ 50 years in England. Participants Analyses examining the association between household temperature and health had a maximum sample of 12,210 adults aged 50–90 years. The RD analyses drew on a maximum of 5902 observations. Intervention The WFP provides households with a member who is aged > 60 years (up to 2010, from which point the minimum age increased) in the qualifying week with a lump sum annual payment, typically in November or December. Main outcome measures Differences in indoor temperature were examined, and, following an extensive literature review of relevant participant-reported health indicators and objectively recorded biomarkers likely to be affected by indoor temperature, a series of key measures were selected: blood pressure, inflammation, lung function, the presence of chest infections, subjective health and depressive symptom ratings. Data sources The first six waves of the ELSA were drawn from, accessible through the UK Data Service (SN:5050 English Longitudinal Study of Ageing: Waves 0–7, 1998–2015). Results Results from both random and fixed-effects multilevel regression models showed that low levels of indoor temperature were associated with raised systolic and diastolic blood pressure levels and raised fibrinogen levels. However, across the RD models, no evidence was found that the WFP was consistently associated with differences in either household temperature or the health of qualifying (vs. non-qualifying) households. Limitations The presence of small effects cannot be ruled out, not detectable because of the sample size in the current study. Conclusions This study capitalised on the sharp assignment rules regarding WFP eligibility to estimate the potential effect of the WFP on household temperature and health in a national sample of English adults. The RD design employed did not identify evidence linking the WFP to warmer homes or potential health and well-being effects. Future work Further research should utilise larger samples of participants close to the WFP eligibility cut-off point examined during particularly cold weather in order to identify whether or not the WFP is linked to health benefits not detected in the current study, which may have implications for population health and the evaluation of the effectiveness of the WFP. Funding The National Institute for Health Research Public Health Research programme.

Modifying the secondary school environment to reduce bullying and aggression: the INCLUSIVE cluster RCT

Abstract: Background Bullying, aggression and violence among children and young people are some of the most consequential public mental health problems. Objectives The INCLUSIVE (initiating change locally in bullying and aggression through the school environment) trial evaluated the Learning Together intervention, which involved students in efforts to modify their school environment using restorative approaches and to develop social and emotional skills. We hypothesised that in schools receiving Learning Together there would be lower rates of self-reported bullying and perpetration of aggression and improved student biopsychosocial health at follow-up than in control schools. Design INCLUSIVE was a cluster randomised trial with integral economic and process evaluations. Setting Forty secondary schools in south-east England took part. Schools were randomly assigned to implement the Learning Together intervention over 3 years or to continue standard practice (controls). Participants A total of 6667 (93.6%) students participated at baseline and 5960 (83.3%) students participated at final follow-up. No schools withdrew from the study. Intervention Schools were provided with (1) a social and emotional curriculum, (2) all-staff training in restorative approaches, (3) an external facilitator to help convene an action group to revise rules and policies and to oversee intervention delivery and (4) information on local needs to inform decisions. Main outcome measures Self-reported experience of bullying victimisation (Gatehouse Bullying Scale) and perpetration of aggression (Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale) measured at 36 months. Intention-to-treat analysis using longitudinal mixed-effects models. Results Primary outcomes – Gatehouse Bullying Scale scores were significantly lower among intervention schools than among control schools at 36 months (adjusted mean difference –0.03, 95% confidence interval –0.06 to 0.00). There was no evidence of a difference in Edinburgh Study of Youth Transitions and Crime scores. Secondary outcomes – students in intervention schools had higher quality of life (adjusted mean difference 1.44, 95% confidence interval 0.07 to 2.17) and psychological well-being scores (adjusted mean difference 0.33, 95% confidence interval 0.00 to 0.66), lower psychological total difficulties (Strengths and Difficulties Questionnaire) score (adjusted mean difference –0.54, 95% confidence interval –0.83 to –0.25), and lower odds of having smoked (odds ratio 0.58, 95% confidence interval 0.43 to 0.80), drunk alcohol (odds ratio 0.72, 95% confidence interval 0.56 to 0.92), been offered or tried illicit drugs (odds ratio 0.51, 95% confidence interval 0.36 to 0.73) and been in contact with police in the previous 12 months (odds ratio 0.74, 95% confidence interval 0.56 to 0.97). The total numbers of reported serious adverse events were similar in each arm. There were no changes for staff outcomes. Process evaluation – fidelity was variable, with a reduction in year 3. Over half of the staff were aware that the school was taking steps to reduce bullying and aggression. Economic evaluation – mean (standard deviation) total education sector-related costs were £116 (£47) per pupil in the control arm compared with £163 (£69) in the intervention arm over the first two facilitated years, and £63 (£33) and £74 (£37) per pupil, respectively, in the final, unfacilitated, year. Overall, the intervention was associated with higher costs, but the mean gain in students’ health-related quality of life was slightly higher in the intervention arm. The incremental cost per quality-adjusted life year was £13,284 (95% confidence interval –£32,175 to £58,743) and £1875 (95% confidence interval –£12,945 to £16,695) at 2 and 3 years, respectively. Limitations Our trial was carried out in urban and periurban settings in the counties around London. The large number of secondary outcomes investigated necessitated multiple statistical testing. Fidelity of implementation of Learning Together was variable. Conclusions Learning Together is effective across a very broad range of key public health targets for adolescents. Future work Further studies are required to assess refined versions of this intervention in other settings. Trial registration Current Controlled Trials ISRCTN10751359. 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. 7, No. 18. See the NIHR Journals Library website for further project information. Additional funding was provided by the Educational Endowment Foundation.

Individual health trainers to support health and well-being for people under community supervision in the criminal justice system: the STRENGTHEN pilot RCT

Abstract: Background Little is known about the effectiveness or cost-effectiveness of interventions, such as health trainer support, to improve the health and well-being of people recently released from prison or serving a community sentence, because of the challenges in recruiting participants and following them up. Objectives This pilot trial aimed to assess the acceptability and feasibility of the trial methods and intervention (and associated costs) for a randomised trial to assess the effectiveness and cost-effectiveness of health trainer support versus usual care. Design This trial involved a pilot multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1 : 1 individual allocation to receive support from a health trainer and usual care or usual care alone, with a mixed-methods process evaluation, in 2017–18. Setting Participants were identified, screened and recruited in Community Rehabilitation Companies in Plymouth and Manchester or the National Probation Service in Plymouth. The intervention was delivered in the community. Participants Those who had been out of prison for at least 2 months (to allow community stabilisation), with at least 7 months of a community sentence remaining, were invited to participate; those who may have posed an unacceptable risk to the researchers and health trainers and those who were not interested in the trial or intervention support were excluded. Interventions The intervention group received, in addition to usual care, our person-centred health trainer support in one-to-one sessions for up to 14 weeks, either in person or via telephone. Health trainers aimed to empower participants to make healthy lifestyle changes (particularly in alcohol use, smoking, diet and physical activity) and take on the Five Ways to Well-being [Foresight Projects. Mental Capital and Wellbeing: Final Project Report. 2008. URL: www.gov.uk/government/publications/mental-capital-and-wellbeing-making-the-most-of-ourselves-in-the-21st-century (accessed 24 January 2019).], and also signposted to other options for support. The control group received treatment as usual, defined by available community and public service options for improving health and well-being. Main outcome measures The main outcomes included the Warwick–Edinburgh Mental Well-being Scale scores, alcohol use, smoking behaviour, dietary behaviour, physical activity, substance use, resource use, quality of life, intervention costs, intervention engagement and feasibility and acceptability of trial methods and the intervention. Results A great deal about recruitment was learned and the target of 120 participants was achieved. The minimum trial retention target at 6 months (60%) was met. Among those offered health trainer support, 62% had at least two sessions. The mixed-methods process evaluation generally supported the trial methods and intervention acceptability and feasibility. The proposed primary outcome, the Warwick–Edinburgh Mental Well-being Scale scores, provided us with valuable data to estimate the sample size for a full trial in which to test the effectiveness and cost-effectiveness of the intervention. Conclusions Based on the findings from this pilot trial, a full trial (with some modifications) seems justified, with a sample size of around 900 participants to detect between-group differences in the Warwick-Edinburgh Mental Well-being Scale scores at a 6-month follow-up. Future work A number of recruitment, trial retention, intervention engagement and blinding issues were identified in this pilot and recommendations are made in preparation of and within a full trial. Trial registration Current Controlled Trials ISRCTN80475744. 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. 7, No. 20. See the National Institute for Health Research Journals Library website for further project information.

Training teachers in classroom management to improve mental health in primary school children: the STARS cluster RCT

Abstract: Background Poor mental health in childhood is common, persistent and associated with a range of adverse outcomes that include persistent psychopathology, as well as risk-taking behaviour, criminality and educational failure, all of which may also compromise health. There is a growing policy focus on children’s mental health and the role of schools in particular in addressing this. Objectives To evaluate whether or not the Incredible Years® (IY) Teacher Classroom Management (TCM) training improved children’s mental health, behaviour, educational attainment and enjoyment of school, improved teachers’ mental health and relationship with work, and was cost-effective in relation to potential improvements. Design A two-arm, pragmatic, parallel-group, superiority, cluster randomised controlled trial. Setting A total of 80 UK schools (clusters) were recruited in three distinct cohorts between 2012 and 2014 and randomised to TCM (intervention) or teaching as usual [(TAU) control] with follow-ups at 9, 18 and 30 months. Schools and teachers were not masked to allocation. Participants Eighty schools (n = 2075 children) were randomised: 40 (n = 1037 children) to TCM and 40 (n = 1038 children) to TAU. Interventions TCM was delivered to teachers in six whole-day sessions, spread over 6 months. The explicit goals of TCM are to enhance classroom management skills and improve teacher–student relationships. Main outcome measures The primary planned outcome was the teacher-reported Strengths and Difficulties Questionnaire Total Difficulties (SDQ-TD) score. Random-effects linear regression and marginal logistic regression models using generalized estimating equations were used to analyse outcomes. Results The intervention reduced the SDQ-TD score at 9 months [adjusted mean difference (AMD) –1.0, 95% confidence interval (CI) –1.9 to –0.1; p = 0.03] but there was little evidence of effects at 18 months (AMD –0.1, 95% CI –1.5 to 1.2; p = 0.85) and 30 months (AMD –0.7, 95% CI –1.9 to 0.4; p = 0.23). Planned subgroup analyses suggested that TCM is more effective than TAU for children with poor mental health. Cost-effectiveness analysis using the SDQ-TD suggested that the probability of TCM being cost-effective compared with TAU was associated with some uncertainty (range of 40% to 80% depending on the willingness to pay for a unit improvement in SDQ-TD score). In terms of quality-adjusted life-years (QALYs), there was evidence to suggest that TCM was cost-effective compared with TAU at the National Institute for Health and Care Excellence thresholds of £20,000–30,000 per QALY at 9- and 18-month follow-up, but not at 30-month follow-up. There was evidence of reduced disruptive behaviour (p = 0.04) and reductions in inattention and overactivity (p = 0.02) at the 30-month follow-up. Despite no main effect on educational attainment, subgroup analysis indicated that the intervention’s effect differed between those who did and those who did not have poor mental health for both literacy (interaction p = 0.04) and numeracy (interaction p = 0.03). Independent blind observations and qualitative feedback from teachers suggested that teachers’ behaviour in the classroom changed as a result of attending TCM training. Limitations Teachers were not masked to allocation and attrition was marked for parent-reported data. Conclusions Our findings provide tentative evidence that TCM may be an effective universal child mental health intervention in the short term, particularly for primary school children who are identified as struggling, and it may be a cost-effective intervention in the short term. Future work Further research should explore TCM as a whole-school approach by training all school staff and should evaluate the impact of TCM on academic progress in a more thorough and systematic manner. Trial registration Current Controlled Trials ISRCTN84130388. 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. 7, No. 6. See the NIHR Journals Library website for further project information. Funding was also provided by the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula (NIHR CLAHRC South West Peninsula).

A loyalty scheme to encourage physical activity in office workers: a cluster RCT

Abstract: Background Increasing physical activity in the workplace can provide physical and mental health benefits for employees and economic benefits for the employer through reduced absenteeism and increased productivity. However, there is limited evidence on effective behaviour change interventions in workplace settings that led to maintained physical activity. This study aimed to address this gap and contribute to the evidence base for effective and cost-effective workplace interventions. Objectives To determine the effectiveness and cost-effectiveness of the Physical Activity Loyalty scheme, a multicomponent intervention based on concepts similar to those that underpin a high-street loyalty card, which was aimed at encouraging habitual physical activity behaviour and maintaining increases in mean number of steps per day. Design A cluster randomised controlled trial with an embedded economic evaluation, behavioural economic experiments, mediation analyses and process evaluation. Setting Office-based employees from public sector organisations in Belfast and Lisburn city centres in Northern Ireland. Participants A total of 853 participants [mean age 43.6 years (standard deviation 9.6 years); 71% of participants were female] were randomly allocated by cluster to either the intervention group or the (waiting list) control group. Intervention The 6-month intervention consisted of financial incentives (retail vouchers), feedback and other evidence-based behaviour change techniques. Sensors situated in the vicinity of the workplaces allowed participants to monitor their accumulated minutes of physical activity. Main outcome measures The primary outcome was mean number of steps per day recorded using a sealed pedometer (Yamax Digiwalker CW-701; Yamax, Tasley, UK) worn on the waist for 7 consecutive days and at 6 and 12 months post intervention. Secondary outcomes included health, mental well-being, quality of life, work absenteeism and presenteeism, and the use of health-care resources. Results The mean number of steps per day were significantly lower for the intervention group than the control group [6990 mean number of steps per day (standard deviation 3078) vs. 7576 mean number of steps per day (standard deviation 3345), respectively], with an adjusted mean difference of –336 steps (95% confidence interval –612 to –60 steps; p = 0.02) at 6 months post baseline, but not significantly lower at 12 months post baseline. There was a small but significant enhancement of mental well-being in the intervention group (difference between groups for the Warwick–Edinburgh Mental Wellbeing Scale of 1.34 points, 95% confidence interval 0.48 to 2.20 points), but not for the other secondary outcomes. An economic evaluation suggested that, overall, the scheme was not cost-effective compared with no intervention. The intervention was £25.85 (95% confidence interval –£29.89 to £81.60) more costly per participant than no intervention and had no effect on quality-adjusted life-years (incremental quality-adjusted life-years –0.0000891, 95% confidence interval –0.008 to 0.008). Limitations Significant restructuring of participating organisations during the study resulted in lower than anticipated recruitment and retention rates. Technical issues affected intervention fidelity. Conclusions Overall, assignment to the intervention group resulted in a small but significant decline in the mean pedometer-measured steps per day at 6 months relative to baseline, compared with the waiting list control group. The Physical Activity Loyalty scheme was deemed not to be cost-effective compared with no intervention, primarily because no additional quality-adjusted life-years were gained through the intervention. Research to better understand the mechanisms of physical activity behaviour change maintenance will help the design of future interventions. Trial registration Current Controlled Trials ISRCTN17975376. 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. 7, No. 15. See the NIHR Journals Library website for further project information.

A brief behavioural intervention to promote regular self-weighing to prevent weight regain after weight loss: a RCT

Abstract: Background Although behavioural weight loss treatments can be effective, long-term maintenance of this weight loss remains a critical challenge because the vast majority of people will regain their lost weight over time. The period after initial weight loss is the time when people are at the highest risk of weight regain. Objective The primary aim of this study was to evaluate the effectiveness and cost-effectiveness of a brief behavioural intervention delivered by non-specialist call centre staff to promote regular self-weighing to prevent weight regain after intentional weight loss. Design Randomised controlled trial. Setting West Midlands, UK. Participants Adults were recruited if they had attended a local authority-funded weight management programme and had lost ≥ 5% of their starting weight by the end of their weight loss programme. Interventions The intervention group received three brief support telephone calls, delivered by non-specialist call centre staff (from a third-sector community organisation), that encouraged setting a weight maintenance target of ≤ 1 kg of weight gain from current weight, which was to be assessed by daily self-weighing and recording weight on a record card, together with regular text messages. Participants were asked to return to their weight loss plan if they gained > 1 kg above their target weight. The usual-care group received a standard weight maintenance leaflet, the infographic EatWell Plate and a list of useful websites pertaining to weight management. Main outcome measures The primary outcome was the difference between the groups in mean weight change (kg) from baseline to 12 months. The secondary outcomes included the proportion of participants in each group who had regained < 1 kg in weight at the 3- and 12-month follow-up points. Results A total of 813 potential participants were screened, 583 of whom were eligible and randomised (usual care, n = 292; intervention, n = 291). A total of 94% and 89% of participants completed follow-up at 3 and 12 months, respectively. At 12 months, the mean unadjusted weight change was +0.39 kg for the intervention group and –0.17 kg for the usual-care group, an adjusted difference of 0.53 kg [95% confidence interval (CI) –0.64 to 1.71 kg]. At 12 months, 134 (45.9%) and 130 (44.7%) participants regained ≤ 1 kg of their baseline weight in the usual-care and intervention groups, respectively (odds ratio 0.96, 95% CI 0.69 to 1.33). As the intervention was ineffective, we did not pursue a cost-effectiveness analysis. Conclusions Brief behavioural telephone support delivered by non-specialist workers to promote target-setting and daily self-weighing and recording of weight does not prevent weight regain after intentional weight loss. Specifically, as target-setting and daily self-weighing did not increase conscious cognitive restraint, people may need more intensive interventions to promote the use of behavioural techniques that help people maintain lost weight. Trial registration Current Controlled Trials ISRCTN52341938. 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. 7, No. 7. See the NIHR Journals Library website for further project information.

Development and piloting of a highly tailored digital intervention to support adherence to antihypertensive medications as an adjunct to primary care consultations

Abstract: Objectives This paper describes the systematic development and piloting of a highly tailored text and voice message intervention to increase adherence to medication in primary care. Methods Following the Medical Research Council guidance, this paper describes (a) the systematic development of the theoretical framework, based on review of theories and meta-analyses of effectiveness; (b) the systematic development of the delivery mode, intervention content and implementation procedures, based on consultations, face-to-face interviews, think-aloud protocols, focus groups, systematic reviews, patient and public involvement/engagement input, intervention pre-test; and (c) the piloting of the intervention, based on a 1-month intervention; and follow-up assessment including interviews and questionnaires. The mixed-methods analysis combined findings from the parallel studies complementarily. Results intervention development suggested the target behaviour of the intervention should be the tablets taken at a regular time of the day. It recommended that patients could be more receptive to intervention content when they initiate medication taking or they change prescription plan; and more emphasis is needed to patients’ consent process. Intervention piloting suggested high intervention engagement with, and fidelity of, the intervention content; which included a combination of behaviour change techniques, and was highly tailored to patients’ beliefs and prescription plan. Patients reported that the intervention content increased awareness about the necessity to take and maintain adherent to medication, reinforced social support and habit formation, and reminded them to take medication as prescribed. Conclusion Tailored automated text and voice message interventions are feasible ways to improve medication adherence as an adjunct to primary care. Trial registration number ISRCTN10668149.

A revised teaching assistant-led extracurricular physical activity programme for 8- to 10-year-olds: the Action 3:30R feasibility cluster RCT

Abstract: Background Many children do not meet the recommended guidelines for physical activity. The after-school period may be a critical time for children to participate in physical activity. Teaching assistants are important within the school system and could be trained to deliver after-school physical activity programmes. Our previous work showed that a teaching assistant-led after-school physical activity intervention held promise. Objectives To examine the feasibility, evidence of promise and cost of Action 3:30R, a revised after-school physical activity intervention. Design A cluster-randomised feasibility study, including process and economic evaluations. Setting The setting was 12 primary schools in south-west England. Participants The participants were Year 4 and 5 children (aged 8–10 years). Intervention Two teaching assistants from each intervention school attended a 25-hour (5-day) training course focused on how to deliver an after-school physical activity programme. As Action 3:30 is grounded in self-determination theory, the training focused on promoting children’s autonomy, belonging and competence. Teaching assistants received resources to aid them in delivering a 60-minute after-school physical activity programme twice per week for 15 weeks (i.e. 30 sessions). Main outcome measures Measures focused on feasibility outcomes and evidence of promise. Feasibility measures included the recruitment of schools and pupils and the attendance at the after-school programme. Evidence of promise was measured by comparing accelerometer-determined minutes of moderate to vigorous physical activity between the arms at follow-up. Process evaluation measures were conducted using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. The cost of delivery was also assessed. Results Twelve primary schools were recruited and 41% of eligible pupils consented, 49% of whom were girls. Schools were randomised after baseline measures: six to the intervention arm (n = 170 pupils) and six to the control arm (n = 165 pupils). Two schools allocated to the intervention arm withdrew from the study before the start of the intervention, leaving 111 pupils in the intervention arm. The intervention training was well attended and positively received; eight out of nine teaching assistants attended 100% of the sessions. Action 3:30R clubs were well attended; 74% of pupils attended at least 50% of the 30 sessions. Mean weekday moderate to vigorous physical activity did not differ between the arms at follow-up (–0.5 minutes, 95% confidence interval –4.57 to 3.57 minutes). The process evaluation revealed that Action 3:30R was received positively by pupils, teaching assistants and key contacts in intervention schools. Pupils enjoyed Action 3:30R, and teaching assistants and pupils perceived the teaching style to be autonomy-supportive. Economic evaluation showed that Action 3:30R is inexpensive; the estimated cost of the programme after 1 year was £1.64 per pupil per session. Limitations A reason for withdrawing was given by one school but not by the other. The reason given was an inability to release staff for training. Conclusions Action 3:30R is a low-cost, feasible after-school programme that engages a range of pupils and offers continuing professional development to teaching assistants. However, Action 3:30R does not show evidence of promise in increasing levels of moderate to vigorous physical activity and does not warrant a trial evaluation. Future work Future research should focus on improving the quality of current after-school provision in primary schools to increase physical activity. Trial registration Current Controlled Trials ISRCTN34001941. 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. 7, No. 19. See the NIHR Journals Library website for further project information.

A workplace-based intervention to increase levels of daily physical activity: the Travel to Work cluster RCT

Abstract: Background There may be opportunities for working adults to accumulate recommended physical activity levels (≥ 150 minutes of moderate-intensity physical activity in bouts of ≥ 10 minutes throughout the week) during the commute to work. Systematic reviews of interventions to increase active transport indicate that studies are predominantly of poor quality, rely on self-report and lack robust statistical analyses. Objectives To assess the effectiveness, cost and consequences of a behavioural intervention to increase walking during the commute to work. Design A multicentre, parallel-arm, cluster randomised controlled trial incorporating economic and process evaluations. Physical activity outcomes were measured using accelerometers and GPS (Global Positioning System) receivers at baseline and the 12-month follow-up. Setting Workplaces in seven urban areas in south-west England and south Wales. Participants Employees (n = 654) in 87 workplaces. Interventions Workplace-based Walk to Work promoters were trained to implement a 10-week intervention incorporating key behaviour change techniques. Main outcome measures The primary outcome was the daily number of minutes of moderate to vigorous physical activity (MVPA). Secondary outcomes included MVPA during the commute, overall levels of physical activity and modal shift (from private car to walking). Cost–consequences analysis included employer, employee and health service costs and consequences. Process outcomes included barriers to, and facilitators of, walking during the daily commute. Results There was no evidence of an intervention effect on MVPA at the 12-month follow-up [adjusted difference in means 0.3 minutes, 95% confidence interval (CI) –5.3 to 5.9 minutes]. The intervention cost was on average, £181.97 per workplace and £24.19 per participating employee. In comparison with car users [mean 7.3 minutes, standard deviation (SD) 7.6 minutes], walkers (mean 34.3 minutes, SD 18.6 minutes) and public transport users (mean 25.7 minutes, SD 14.0 minutes) accrued substantially higher levels of daily MVPA during the commute. Participants who walked for ≥ 10 minutes during their commute were more likely to have a shorter commute distance (p < 0.001). No access to a car (p < 0.001) and absence of free workplace car parking (p < 0.01) were independently related to walking to work and using public transport. Higher quality-of-life scores were observed for the intervention group in a repeated-measures analysis (mean 0.018, 95% CI 0.000 to 0.036; scores anchored at 0 indicated ‘no capability’ and scores anchored at 1 indicated ‘full capability’). Conclusions Although this research showed that walking to work and using public transport are important contributors to physical activity levels in a working population, the behavioural intervention was insufficient to change travel behaviour. Broader contextual factors, such as length of journey, commuting options and availability of car parking, may influence the effectiveness of behavioural interventions to change travel behaviour. Further analyses of statistical and qualitative data could focus on physical activity and travel mode and the wider determinants of workplace travel behaviour. Trial registration Current Controlled Trials ISRCTN15009100. 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. 7, No. 11. See the NIHR Journals Library website for further project information. Living Streets, a UK charity promoting everyday walking, provided funding for the intervention booklets and free pedometers for distribution to participants in the intervention group.

A peer-led physical activity intervention in schools for adolescent girls: a feasibility RCT

Abstract: Background Girls are less active than boys and few adolescent girls meet physical activity (PA) guidelines. Peers are an important influence on the views and behaviours of adolescent girls, yet many PA interventions involving peers use formal approaches that may not harness the power of peer groups. More informal peer-led PA interventions, which work within proximal peer groups, may hold promise for increasing girls’ PA. Objectives To examine the feasibility, evidence of promise and cost of the Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led PA intervention. Design Phase 1 comprised formative work and a pilot study conducted in one secondary school. Phase 2 was a feasibility study comprising a pilot randomised controlled trial in six secondary schools, including process and economic evaluations. Setting Six secondary schools in South Gloucestershire and Wiltshire, recruited from schools above the median local Pupil Premium (i.e. more deprived). Participants Year 8 girls (aged 12–13 years). Intervention Year 8 girls nominated other girls in their year who are likely to be influential (e.g. who they look up to, are good listeners); the 18% most nominated were invited to be peer supporters (PSs). PSs attended 2 consecutive days of training (plus a top-up day 5 weeks later) outside the school site, led by pairs of PS trainers, to increase their knowledge about PA and their capabilities and confidence to promote PA in their friendship group. Main outcome measures Measures focused on establishing evidence for feasibility and promise: recruitment and retention of Year 8 girls and PSs, data provision rates [accelerometer and questionnaire collected pre randomisation/beginning of Year 8 (T0), end of Year 8 (T1) and beginning of Year 9 (T2)], intervention acceptability, PS training attendance, intervention cost, and the between-arm difference in weekday minutes of moderate to vigorous PA (MVPA). A process evaluation was conducted. Results Six schools were recruited: four PLAN-A (n = 269) and two control (n = 158). In total, 94.7% of Year 8 girls participated. A total of 55 (17–24% of Year 8 girls) PSs were trained (attendance rate 91–100%). Five girls were trained as PS trainers. Questionnaire data provision exceeded 92% at all time points. Accelerometer return rates were > 85% and wear-time criteria were met by 83%, 71% and 62% of participants at T0, T1 and T2, respectively. Mean weekday MVPA did not differ between intervention arms at T1 (1.1 minutes, 95% CI –4.3 to 6.5 minutes) but did at T2 (6.1 minutes, 95% CI 1.4 to 10.8 minutes), favouring PLAN-A. The mean cost of intervention delivery was £2685 per school or £37 per Year 8 girl. Process evaluation identified good fidelity, engagement and enjoyment of the PS training and peer-support strategies. PSs needed more guidance on how to start conversations. Limitations Accelerometer data provision was lowest at T2, suggesting a need for strategies to increase compliance. Conclusions Informal peer-led intervention approaches, such as PLAN-A, hold promise as a means of promoting PA to adolescent girls. Future work A definitive randomised controlled trial of PLAN-A is warranted. Trial registration Current Controlled Trials ISRCTN12543546. 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. 7, No. 16. See the NIHR Journals Library website for further project information. The work was undertaken with the support of the Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UK Clinical Research Collaboration (UKCRC) Public Health Research Centre of Excellence. Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UKCRC, is gratefully acknowledged. This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UK CRC-registered clinical trials unit in receipt of NIHR clinical trials unit support funding. The intervention costs were jointly funded by South Gloucestershire Council and Wiltshire Council.

Socio-economic, Demographic and Environmental Factors Effects on Under-Five Mortality in Empowered Action Group States of India: An Evidence from NFHS-4

Abstract: Background: Globally, in both under developed and developing countries including India have experience substantial decline under-five mortality rate i.e., infant and child mortality rates due to reproductive and child health programme intervention during past two decades. In India, overall U5MR has been declined from 74 per thousand live births in 2005-06 to 50 per thousand live births in 2015-16. The Empowered Action Group (EAG) of states has very high under-five mortality as compared to Non-EAG states. The aim of the study was to identify the socio-economic, demographic and environmental factors effect on U5MR in EAG States of India. Data and Methods: The 9 EAG States NFHS-4 data had been analyzed and used for this study. The National Family Health Survey is a cross-sectional household survey conducted in year 2015-16. The survival analysis i.e., Kaplan-Meier with log-rank test and Cox-proportional hazard regression model was used to assess the effects of socio-economic, demographic and environmental factors on risk of under-five mortality. Total information of 322396 children born during past ten years preceding survey and their mother's characteristics were analyzed. Results: The result showed that under-five mortality was significantly associated with mother's age at the time of birth, sex of the child, previous birth interval, birth order, household wealth, toilet facility and cooking fuel. Children of young mother < 20 years are 4-5 times more likely to die as compared to children of mother's age 20-29 years (HR = 4.67, 95% CI: 4.17-5.20) after controlling for other factors. The risk of dying was higher among children whose mother' illiterate and poor household compared to children whose mothers were literate and belong to rich household. Conclusion: To achieve the sustainable development goal 3 targets on under-five mortality by 2030, the EAG states clearly need to reduce U5MR [1].

Randomised controlled trial with economic and process evaluations of domiciliary welfare rights advice for socioeconomically disadvantaged older people recruited via primary health care (the Do-Well study)

Abstract: Background Welfare rights advice services are effective at maximising previously unclaimed welfare benefits, but their impact on health has not been evaluated. Objective To establish the acceptability, cost-effectiveness and effect on health of a domiciliary welfare rights advice service targeting older people, compared with usual practice. Design A pragmatic, individually randomised, parallel-group, single-blinded, wait-list controlled trial, with economic and process evaluations. Data were collected by interview at baseline and 24 months, and by self-completion questionnaire at 12 months. Qualitative interviews were undertaken with purposive samples of 50 trial participants and 17 professionals to explore the intervention’s acceptability and its perceived impacts. Setting Participants’ homes in North East England, UK. Participants A total of 755 volunteers aged ≥ 60 years, living in their own homes, fluent in English and not terminally ill, recruited from the registers of 17 general practices with an Index of Multiple Deprivation within the most deprived two-fifths of the distribution for England, and with no previous access to welfare rights advice services. Interventions Welfare rights advice, comprising face-to-face consultations, active assistance with benefit claims and follow-up as required until no longer needed, delivered in participants’ own homes by a qualified welfare rights advisor. Control group participants received usual care until the 24-month follow-up, after which they received the intervention. Main outcome measures The primary outcome was health-related quality of life (HRQoL), assessed using the CASP-19 (Control, Autonomy, Self-realisation and Pleasure) score. The secondary outcomes included general health status, health behaviours, independence and hours per week of care, mortality and changes in financial status. Results A total of 755 out of 3912 (19%) general practice patients agreed to participate and were randomised (intervention, n = 381; control, n = 374). In the intervention group, 335 participants (88%) received the intervention. A total of 605 (80%) participants completed the 12-month follow-up and 562 (75%) completed the 24-month follow-up. Only 84 (22%) intervention group participants were awarded additional benefits. There was no significant difference in CASP-19 score between the intervention and control groups at 24 months [adjusted mean difference 0.3, 95% confidence interval (CI) –0.8 to 1.5], but a significant increase in hours of home care per week in the intervention group (adjusted difference 26.3 hours/week, 95% CI 0.8 to 56.1 hours/week). Exploratory analyses found a weak positive correlation between CASP-19 score and the amount of time since receipt of the benefit (0.39, 95% CI 0.16 to 0.58). The qualitative data suggest that the intervention was acceptable and that receipt of additional benefits was perceived by participants and professionals as having had a positive impact on health and quality of life. The mean cost was £44 per participant, the incremental mean health gain was 0.009 quality-adjusted life-years (QALYs) (95% CI –0.038 to 0.055 QALYs) and the incremental cost-effectiveness ratio was £1914 per QALY gained. Conclusions The trial did not provide sufficient evidence to support domiciliary welfare rights advice as a means of promoting health among older people, but it yielded qualitative findings that suggest important impacts on HRQoL. The intervention needs to be better targeted to those most likely to benefit. Future work Further follow-up of the trial could identify whether or not outcomes diverge among intervention and control groups over time. Research is needed to better understand how to target welfare rights advice to those most in need. Trial registration Current Controlled Trials ISRCTN37380518. 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. 7, No. 3. See the NIHR Journals Library website for further project information. The authors also received a grant of £28,000 from the North East Strategic Health Authority in 2012 to cover the costs of intervention delivery and training as well as other non-research costs of the study.

Unintended Pregnancy and Childbearing among out-of-school Unmarried Young Women Living in Metropolitan City Slums, South-West Nigeria

Abstract: Background: High rate of unintended pregnancy (UPr) and childbearing among young women have always been reported in Nigeria. This study assessed the level of UPr and childbearing among unmarried out-of-school young women living in urban slums in Kosofe Local Government Area, Lagos metropolis, South-West, Nigeria. Method: A cross-sectional community-based study was conducted using a multi-stage sampling technique to select 372 unmarried out-of-school young women (10-24 years). Qualitative and quantitative methods were used for data collection. Data were analyzed using Atlas Ti and logistic regression model (α=0.05). Results: Mean age and mean age at first sexual intercourse of the women was 18.9±2.8 years, and 16.9±2.1 years respectively. About 32.1% have had at least a child, 29% reported ever had an UPr, 13.3% had induced abortion, 2.9% had ever had miscarriage, and 13% are currently pregnant. Visit to health facility, age, knowledge of ovulation, and who the respondent lives with were significantly associated with UPr and childbearing. Age and visit to health facility were the identified predictors of UPr and childbearing. Non-use of contraceptives, lack of parental care, pre-marital sex, covetousness, and peer pressure were mentioned as the common reasons for unintended pregnancy. Participants expressed their interest to delay childbearing. Conclusion: High incidence of unintended pregnancy and childbearing was reported in this study. Framework on female education and youth friendly fertility control services should be strengthened in the study area.

Impact of legislation to reduce the drink-drive limit on road traffic accidents and alcohol consumption in Scotland: a natural experiment study

Abstract: Background It is widely recognised that drink driving is a leading cause of road traffic accidents (RTAs). There is evidence that changing the drink-drive limit from a blood alcohol concentration of 0.08 to 0.05 g/dl is effective in reducing RTAs. Scotland changed the blood alcohol concentration limit to 0.05 g/dl on 5 December 2014. Aims To assess whether or not the numbers and rates of RTAs and per capita alcohol consumption in Scotland were reduced because of the 2014 drink-drive legislation. To assess whether or not the 2014 change in legislation provided good value for money. Design A natural experimental, quantitative study. The control group was England and Wales, that is, the other countries in Great Britain, where the drink-drive legislation remained unchanged. Setting Great Britain. Participants The entire population of Scotland, England and Wales for the period of January 2013–December 2016. Intervention The change to drink-drive legislation in Scotland. Outcome measures The counts and rates of RTAs; and per capita alcohol consumption. Methods For the numbers and rates of RTAs (both traffic flow and population denominators were used), and separately for the intervention and control trial groups, negative binomial regression models were fitted to panel data sets to test for a change in outcome level after the new 2014 legislation was in place. To obtain a ‘difference-in-differences’ (DiD)-type measure of effect, an interaction term between the intervention group indicator and the binary covariate for indicating pre and post change in legislation (‘pseudo’-change for the control group) was assessed. For off- and on-trade per capita alcohol sales, and separately for the intervention and control trial group, seasonal autoregressive integrated moving average error models were fitted to the relevant time series. Results The change to drink-drive legislation was associated with a 2% relative decrease in RTAs in Scotland [relative risk (RR) 0.98, 95% CI 0.91 to 1.04; p = 0.53]. However, the pseudo-change in legislation was associated with a 5% decrease in RTAs in England and Wales (RR 0.95, 95% CI 0.90 to 1.00; p = 0.05). For RTA rates, with traffic flow as the denominator, the DiD-type estimate indicated a 7% increase in rates for Scotland relative to England and Wales (unadjusted RR 1.07, 95% CI 0.98 to 1.17; p = 0.1). The change to drink-drive legislation was associated with a 0.3% relative decrease in per capita off-trade sales (–0.3%, 95% CI –1.7% to 1.1%; p = 0.71) and a 0.7% decrease in per capita on-trade sales (–0.7%, 95% CI –0.8% to –0.5%; p < 0.001). Conclusion The change to drink-drive legislation in Scotland in December 2014 did not have the expected effect of reducing RTAs in the country, and nor did it change alcohol drinking levels in Scotland. This main finding for RTAs was unexpected and the research has shown that a lack of enforcement is the most likely reason for legislation failure. Future work Investigations into how the public interpret and act on changes in drink-drive legislation would be welcome, as would research into whether or not previous change in drink-drive legislation effects on RTAs in other jurisdictions are associated with the level of enforcement that took place. Trial registration Current Controlled Trials ISRCTN38602189. 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. 7, No. 12. See the NIHR Journals Library website for further project information.