Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial.

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

Association of cannabis, cannabidiol and synthetic cannabinoid use with mental health in UK adolescents.

BACKGROUND: Cannabis has been associated with poorer mental health, but little is known of the effect of synthetic cannabinoids or cannabidiol (often referred to as CBD). AIMS: To investigate associations of cannabis, synthetic cannabinoids and cannabidiol with mental health in adolescence. METHOD: We conducted a cross-sectional analysis with 13- to 14-year-old adolescents across England and Wales in 2019-2020. Multilevel logistic regression was used to examine the association of lifetime use of cannabis, synthetic cannabinoids and cannabidiol with self-reported symptoms of probable depression, anxiety, conduct disorder and auditory hallucinations. RESULTS: Of the 6672 adolescents who participated, 5.2% reported using of cannabis, 1.9% reported using cannabidiol and 0.6% reported using synthetic cannabinoids. After correction for multiple testing, adolescents who had used these substances were significantly more likely to report a probable depressive, anxiety or conduct disorder, as well as auditory hallucinations, than those who had not. Adjustment for socioeconomic disadvantage had little effect on associations, but weekly tobacco use resulted in marked attenuation of associations. The association of cannabis use with probable anxiety and depressive disorders was weaker in those who reported using cannabidiol than those who did not. There was little evidence of an interaction between synthetic cannabinoids and cannabidiol. CONCLUSIONS: To our knowledge, this study provides the first general population evidence that synthetic cannabinoids and cannabidiol are associated with probable mental health disorders in adolescence. These associations require replication, ideally with prospective cohorts and stronger study designs.

A peer-led, school-based social network intervention for young people in the UK, promoting sexual health via social media and conversations with friends: intervention development and optimisation of STASH.

BACKGROUND: The quality of school-based sex and relationships education (SRE) is variable in the UK. Digitally-based interventions can usefully supplement teacher-delivered lessons and positively impact sexual health knowledge. Designed to address gaps in core SRE knowledge, STASH (Sexually Transmitted infections And Sexual Health) is a peer-led social network intervention adapted from the successful ASSIST (A Stop Smoking in Schools Trial) model, and based on Diffusion of Innovation theory. This paper describes how the STASH intervention was developed and refined. METHODS: Drawing on the Six Steps in Quality Intervention Development (6SQuID) framework, we tested a provisional programme theory through three iterative stages -: 1) evidence synthesis; 2) intervention co-production; and 3) adaptation - which incorporated evidence review, stakeholder consultation, and website co-development and piloting with young people, sexual health specialists, and educators. Multi-method results were analysed in a matrix of commonalities and differences. RESULTS: Over 21 months, intervention development comprised 20 activities within the three stages. 1) We identified gaps in SRE provision and online resources (e.g. around sexual consent, pleasure, digital literacy), and confirmed critical components including the core ASSIST peer nomination process, the support of schools, and alignment to the national curriculum. We reviewed candidate social media platforms, ruling out all except Facebook on basis of functionality restrictions which precluded their use for our purposes. 2) Drawing on these findings, as well as relevant behaviour change theories and core elements of the ASSIST model, we co-developed new content with young people and other stakeholders, tailored to sexual health and to delivery via closed Facebook groups, as well as face-to-face conversations. 3) A pilot in one school highlighted practical considerations, including around peer nomination, recruitment, awareness raising, and boundaries to message sharing. From this, a revised STASH intervention and programme theory were co-developed with stakeholders. CONCLUSIONS: STASH intervention development required extensive adaptation from the ASSIST model. Although labour intensive, our robust co-development approach ensured that an optimised intervention was taken forward for feasibility testing. Evidencing a rigorous approach to operationalising existing intervention development guidance, this paper also highlights the significance of balancing competing stakeholder concerns, resource availability, and an ever-changing landscape for implementation. TRIAL REGISTRATION: ISRCTN97369178.

Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial.

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

Effectiveness of the Strengthening Families Programme in the UK at preventing substance misuse in 10-14 year-olds: a pragmatic randomised controlled trial.

OBJECTIVES: The Strengthening Families Programme 10-14 (SFP10-14) is a USA-developed universal group-based intervention aiming to prevent substance misuse by strengthening protective factors within the family. This study evaluated a proportionate universal implementation of the adapted UK version (SFP10-14UK) which brought together families identified as likely/not likely to experience/present challenges within a group setting. DESIGN: Pragmatic cluster-randomised controlled effectiveness trial, with families as the unit of randomisation and embedded process and economic evaluations. SETTING: The study took place in seven counties of Wales, UK. PARTICIPANTS: 715 families (919 parents/carers, 931 young people) were randomised. INTERVENTIONS: Families randomised to the intervention arm received the SFP10-14 comprising seven weekly sessions. Families in intervention and control arms received existing services as normal. OUTCOME MEASURES: Primary outcomes were the number of occasions young people reported drinking alcohol in the last 30 days; and drunkenness during the same period, dichotomised as 'never' and '1-2 times or more'. Secondary outcomes examined alcohol/tobacco/substance behaviours including: cannabis use; weekly smoking (validated by salivary cotinine measures); age of alcohol initiation; frequency of drinking >5 drinks in a row; frequency of different types of alcoholic drinks; alcohol-related problems. Retention: primary analysis included 746 young people (80.1%) (alcohol consumption) and 732 young people (78.6%) (drunkenness). RESULTS: There was no evidence of statistically significant between-group differences 2 years after randomisation for primary outcomes (young people's alcohol consumption in the last 30 days adjusted OR=1.11, 95% CI 0.72 to 1.71, p=0.646; drunkenness in the last 30 days adjusted OR=1.46, 95% CI 0.83 to 2.55, p=0.185). There were no statistically significant between-group differences for other substance use outcomes, or those relating to well-being/stress, and emotional/behavioural problems. CONCLUSIONS: Previous evidence of effectiveness was not replicated. Findings highlight the importance of evaluating interventions when they are adapted for new settings. TRIAL REGISTRATION NUMBER: ISRCTN63550893.Cite Now.

MECHANISMS Study: Using Game Theory to Assess the Effects of Social Norms and Social Networks on Adolescent Smoking in Schools-Study Protocol.

This proof of concept study harnesses novel transdisciplinary insights to contrast two school-based smoking prevention interventions among adolescents in the UK and Colombia. We compare schools in these locations because smoking rates and norms are different, in order to better understand social norms based mechanisms of action related to smoking. We aim to: (1) improve the measurement of social norms for smoking behaviors in adolescents and reveal how they spread in schools; (2) to better characterize the mechanisms of action of smoking prevention interventions in schools, learning lessons for future intervention research. The A Stop Smoking in Schools Trial (ASSIST) intervention harnesses peer influence, while the Dead Cool intervention uses classroom pedagogy. Both interventions were originally developed in the UK but culturally adapted for a Colombian setting. In a before and after design, we will obtain psychosocial, friendship, and behavioral data (e.g., attitudes and intentions toward smoking and vaping) from ~300 students in three schools for each intervention in the UK and the same number in Colombia (i.e., ~1,200 participants in total). Pre-intervention, participants take part in a Rule Following task, and in Coordination Games that allow us to assess their judgments about the social appropriateness of a range of smoking-related and unrelated behaviors, and elicit individual sensitivity to social norms. After the interventions, these behavioral economic experiments are repeated, so we can assess how social norms related to smoking have changed, how sensitivity to classroom and school year group norms have changed and how individual changes are related to changes among friends. This Game Theoretic approach allows us to estimate proxies for norms and norm sensitivity parameters and to test for the influence of individual student attributes and their social networks within a Markov Chain Monte Carlo modeling framework. We identify hypothesized mechanisms by triangulating results with qualitative data from participants. The MECHANISMS study is innovative in the interplay of Game Theory and longitudinal social network analytical approaches, and in its transdisciplinary research approach. This study will help us to better understand the mechanisms of smoking prevention interventions in high and middle income settings.

Have e-cigarettes renormalised or displaced youth smoking? Results of a segmented regression analysis of repeated cross sectional survey data in England, Scotland and Wales.

OBJECTIVES: To examine whether during a period of limited e-cigarette regulation and rapid growth in their use, smoking began to become renormalised among young people. DESIGN: Interrupted time-series analysis of repeated cross-sectional time-series data. SETTING: Great Britain PARTICIPANTS: 248 324 young people aged approximately 13 and 15 years, from three national surveys during the years 1998-2015. INTERVENTION: Unregulated growth of e-cigarette use (following the year 2010, until 2015). OUTCOME MEASURES: Primary outcomes were prevalence of self-reported ever smoking and regular smoking. Secondary outcomes were attitudes towards smoking. Tertiary outcomes were ever use of cannabis and alcohol. RESULTS: In final models, no significant change was detected in the pre-existing trend for ever smoking (OR 1.01, CI 0.99 to 1.03). There was a marginally significant slowing in the rate of decline for regular smoking (OR 1.04, CI 1.00 to 1.08), accompanied by a larger slowing in the rate of decline of cannabis use (OR 1.21, CI 1.18 to 1.25) and alcohol use (OR 1.17, CI 1.14 to 1.19). In all models and subgroup analyses for smoking attitudes, an increased rate of decline was observed after 2010 (OR 0.88, CI 0.86 to 0.90). Models were robust to sensitivity analyses. CONCLUSIONS: There was a marginal slowing in the decline in regular smoking during the period following 2010, when e-cigarettes were emerging but relatively unregulated. However, these patterns were not unique to tobacco use and the decline in the acceptability of smoking behaviour among youth accelerated during this time. These analyses provide little evidence that renormalisation of youth smoking was occurring during a period of rapid growth and limited regulation of e-cigarettes from 2011 to 2015. TRIAL REGISTRATION NUMBER: Research registry number: researchregistry4336.

Diffusion of effects of the ASSIST school-based smoking prevention intervention to non-participating family members: a secondary analysis of a randomized controlled trial.

AIMS: To investigate whether effects of the ASSIST (A Stop Smoking In Schools Trial) school-based smoking prevention intervention diffused from students to the people they lived with. DESIGN: Secondary analysis of a cluster-randomized control trial (cRCT). SETTING: England and Wales. PARTICIPANTS: A total of 10 730 students aged 12-13 years in 59 schools assigned using stratified block randomization to the control (29 schools, 5372 students) or intervention (30 schools, 5358 students) condition. INTERVENTION AND COMPARATOR: The ASSIST intervention involves 2 days of off-site training of influential students to encourage their peers not to smoke during a 10-week period. The control group continued with their usual education. MEASUREMENTS: The outcomes were the proportion of students who self-reported living with a smoker and the smoking status of each resident family member/caregiver. Follow-up assessments were immediately after the intervention and at 1 and 2 years post-intervention. FINDINGS: The odds ratio (OR) for living with a smoker in the intervention compared with the control groups was 0.86 [95% confidence interval (CI) = 0.72, 1.03] immediately after the intervention, OR = 0.84 (95% CI = 0.72, 0.97) at a 1-year follow-up and OR = 0.86 (95% CI = 0.75, 0.99) at 2-year follow-up. In a three-tier multi-level model with data from all three follow-ups, student-reported smoking by fathers (OR = 0.90, 95% CI = 0.80, 1.00), brothers (OR = 0.78, 95% CI = 0.67, 0.92) and sisters (OR = 0.80, 95% CI = 0.69, 0.92) was lower in the intervention compared with control group. Subgroup analyses by baseline smoking status suggested that these effects were more consistent with prevention of uptake than prompting cessation. CONCLUSIONS: A Stop Smoking In Schools Trial (ASSIST) school-based smoking prevention intervention may have reduced the prevalence of smoking in people who lived with ASSIST-trained students. This indirect transmission is consistent with the predictions of diffusion of innovations theory which underpins the design of ASSIST.

The relative importance of perceived substance misuse use by different peers on smoking, alcohol and illicit drug use in adolescence.

BACKGROUND: Substance use by young people is strongly associated with that of their peers. Little is known about the influence of different types of peers. We tested the relationship between perceived substance use by five types of peers and adolescents' use of illicit drugs, smoking, and alcohol consumption. METHODS: We used data collected from 1285 students aged 12-13 as part of a pilot cluster randomized controlled trial (United Kingdom, 2014-2016). The exposures were the perceived use of illicit drugs, smoking and alcohol consumption by best friends, boy or girlfriends, brothers or sisters, friends outside of school and online. Outcomes were self-reported lifetime use of illicit drugs, smoking and alcohol consumption assessed 18-months later. RESULTS: The lifetime prevalence of illicit drug use, smoking and alcohol consumption at the 18-month follow-up were 14.3%, 24.9% and 54.1%, respectively. In the fully adjusted models, perceived substance use by friends outside of school, brothers or sisters, and online had the most consistent associations with outcomes. Perceived use by friends online was associated with an increased risk of ever having used illicit drugs (odds ratio [OR] = 2.43, 95% confidence interval [CI] = 1.26, 4.69), smoking (OR = 1.61, 95% CI 0.96, 2.70) and alcohol consumption (OR = 2.98, 95% CI = 1.71, 5.18). CONCLUSIONS: Perceived substance use by friends outside of school, brothers and sisters and online could be viable sources of peer influence. If these findings are replicated, a greater emphasis should be made in interventions to mitigate the influence of these peers.

A physical activity, nutrition and oral health intervention in nursery settings: process evaluation of the NAP SACC UK feasibility cluster RCT.

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

Implementation of a peer-led school based smoking prevention programme: a mixed methods process evaluation.

BACKGROUND: Smoking prevention programmes that reach adolescents before they experiment with tobacco may reduce the prevalence of tobacco use. ASSIST is a school-based, peer-led smoking prevention programme that encourages the diffusion of non-smoking norms among secondary school students (aged 12-13), and was shown in a randomised control trial (conducted 2001-2004) to reduce the prevalence of weekly smoking. This paper presents findings from a process evaluation of the implementation of ASSIST in Scotland in 2014-2017. It examines acceptability and fidelity of implementation and explores the context of message diffusion between peers. METHODS: Mixed method implementation study with students (n = 61), school staff (n = 41), trainers (n = 31) and policy and commissioning leads (n = 17), structured observations (n = 42) and student surveys (n = 2130). RESULTS: ASSIST was delivered with a high degree of fidelity to the licensed manual with all elements of the programme implemented. Student survey findings indicated that the frequency of conversations about smoking increased over the ASSIST delivery period (18% at baseline, 26% at follow-up), but student recollection of conversations about smoking with peer supporters was low (9%). The delivery context of ASSIST was important when considering perceptions of message diffusion. In the study schools, survey findings showed that 0.9% (n = 19) of participants were regular smokers (at least once a week), with nine out of ten (89.9%, n = 1880) saying they had never smoked. This very low prevalence may have affected when and with whom conversations took place. Study participants indicated that there were wider benefits of taking part in ASSIST for: peer supporters (i.e. personal and communication skills); schools (an externally delivered health promotion programme that required minimal resource from schools); and communities (via communication about the risks of smoking to wider social networks). CONCLUSIONS: ASSIST in Scotland was delivered with a high degree of fidelity to the licensed programme and was acceptable from the perspective of schools, students and trainers. Targeting ASSIST in deprived areas with higher youth smoking prevalence or in other countries where youth smoking rates are rising or higher than in Scotland may be particularly relevant for the future delivery.

Peer-led intervention to prevent and reduce STI transmission and improve sexual health in secondary schools (STASH): protocol for a feasibility study.

BACKGROUND: Young people in the UK are at highest risk of sexually transmitted infections and report higher levels of unsafe sex than any other age group. Involving peer supporters in intervention delivery is acceptable to students and effective in reducing risk behaviours via 'diffusion of innovation', particularly where peer supporters are influential in their networks. Informal peer-led interventions offer a useful alternative to peer-led didactic teaching, which has shown limited effects. Building on the successful ASSIST anti-smoking intervention, the 'STis And Sexual Health' (STASH) intervention involves identification and recruitment of the most influential students as peer supporters, training and support to these students by specialist trainers, positive sex and relationships messages, spread by peer supporters to their friendship groups in person and via social media. METHODS/DESIGN: This protocol describes a feasibility trial of the STASH intervention in six schools. It builds on an earlier study phase of intervention co-development using patient and public involvement (PPI) activities, followed by a pilot of intervention components and evaluation tools in one school. Participants are fourth year (S4) students (aged 14-16) in state-funded Scottish secondary schools who have received some level of teacher-led sex education. The previous cohort of S4 students (those completing S4 in the year prior to the intervention) will serve as controls. Data will be collected from controls (month 16), baseline (month 20-21) and follow-up (month 27-30) via a web-based questionnaire, which will measure (and test the reliability of) primary outcome measures for a phase III trial (delayed initiation of/abstinence from sex and consistent condom use), secondary outcomes and mediators of sexual behaviour (including school climate and social networks). The main feasibility outcome is whether the study meets pre-set progression criteria regarding feasibility and acceptability, measured largely via a process evaluation (basic measures in all 6 schools and in-depth in 2-4 schools). An economic evaluation reporting costs alongside consequences will be conducted. DISCUSSION: This study will inform decisions on the feasibility, design and sample size for a phase III effectiveness trial to assess whether the STASH intervention is effective in reducing the risk of sexually transmitted infections in young people. TRIAL REGISTRATION: ISRCTN97369178.

Development of a framework for the co-production and prototyping of public health interventions.

BACKGROUND: Existing guidance for developing public health interventions does not provide information for researchers about how to work with intervention providers to co-produce and prototype the content and delivery of new interventions prior to evaluation. The ASSIST + Frank study aimed to adapt an existing effective peer-led smoking prevention intervention (ASSIST), integrating new content from the UK drug education resource Talk to Frank ( www.talktofrank.com ) to co-produce two new school-based peer-led drug prevention interventions. A three-stage framework was tested to adapt and develop intervention content and delivery methods in collaboration with key stakeholders to facilitate implementation. METHODS: The three stages of the framework were: 1) Evidence review and stakeholder consultation; 2) Co-production; 3) Prototyping. During stage 1, six focus groups, 12 consultations, five interviews, and nine observations of intervention delivery were conducted with key stakeholders (e.g. Public Health Wales [PHW] ASSIST delivery team, teachers, school students, health professionals). During stage 2, an intervention development group consisting of members of the research team and the PHW ASSIST delivery team was established to adapt existing, and co-produce new, intervention activities. In stage 3, intervention training and content were iteratively prototyped using process data on fidelity and acceptability to key stakeholders. Stages 2 and 3 took the form of an action-research process involving a series of face-to-face meetings, email exchanges, observations, and training sessions. RESULTS: Utilising the three-stage framework, we co-produced and tested intervention content and delivery methods for the two interventions over a period of 18 months involving external partners. New and adapted intervention activities, as well as refinements in content, the format of delivery, timing and sequencing of activities, and training manuals resulted from this process. The involvement of intervention delivery staff, participants and teachers shaped the content and format of the interventions, as well as supporting rapid prototyping in context at the final stage. CONCLUSIONS: This three-stage framework extends current guidance on intervention development by providing step-by-step instructions for co-producing and prototyping an intervention's content and delivery processes prior to piloting and formal evaluation. This framework enhances existing guidance and could be transferred to co-produce and prototype other public health interventions. TRIAL REGISTRATION: ISRCTN14415936 , registered retrospectively on 05 November 2014.

E-cigarette use and intentions to smoke among 10-11-year-old never-smokers in Wales.

BACKGROUND: E-cigarettes are seen by some as offering harm reduction potential, where used effectively as smoking cessation devices. However, there is emerging international evidence of growing use among young people, amid concerns that this may increase tobacco uptake. Few UK studies examine the prevalence of e-cigarette use in non-smoking children or associations with intentions to smoke. METHODS: A cross-sectional survey of year 6 (10-11-year-old) children in Wales. Approximately 1500 children completed questions on e-cigarette use, parental and peer smoking, and intentions to smoke. Logistic regression analyses among never smoking children, adjusted for school-level clustering, examined associations of smoking norms with e-cigarette use, and of e-cigarette use with intentions to smoke tobacco within the next 2 years. RESULTS: Approximately 6% of year 6 children, including 5% of never smokers, reported having used an e-cigarette. By comparison to children whose parents neither smoked nor used e-cigarettes, children were most likely to have used an e-cigarette if parents used both tobacco and e-cigarettes (OR=3.40; 95% CI 1.73 to 6.69). Having used an e-cigarette was associated with intentions to smoke (OR=3.21; 95% CI 1.66 to 6.23). While few children reported that they would smoke in 2 years' time, children who had used an e-cigarette were less likely to report that they definitely would not smoke tobacco in 2 years' time and were more likely to say that they might. CONCLUSIONS: E-cigarettes represent a new form of childhood experimentation with nicotine. Findings are consistent with a hypothesis that children use e-cigarettes to imitate parental and peer smoking behaviours, and that e-cigarette use is associated with weaker antismoking intentions.

Association between breakfast consumption and educational outcomes in 9-11-year-old children.

OBJECTIVE: Breakfast consumption has been consistently associated with health outcomes and cognitive functioning in schoolchildren. Evidence of direct links with educational outcomes remains equivocal. We aimed to examine the link between breakfast consumption in 9-11-year-old children and educational outcomes obtained 6-18 months later. DESIGN: Data on individual-level free school meal entitlement and educational outcomes (Statutory Assessment Tests (SATs) at Key Stage 2) were obtained via the SAIL databank and linked to earlier data collected on breakfast consumption. Multilevel modelling assessed associations between breakfast consumption and SATs. SETTING: Trial of the Primary School Free Breakfast Initiative in Wales. SUBJECTS: Year 5 and 6 students, n 3093 (baseline) and n 3055 (follow-up). RESULTS: Significant associations were found between all dietary behaviours and better performance in SATs, adjusted for gender and individual- and school-level free school meal entitlement (OR=1·95; CI 1·58, 2·40 for breakfast, OR=1·08; CI 1·04, 1·13 for healthy breakfast items). No association was observed between number of unhealthy breakfast items consumed and educational performance. Association of breakfast consumption with educational performance was stronger where the measure of breakfast consumption was more proximal to SATs tests (OR=2·02 measured 6 months prior to SATs, OR=1·61 measured 18 months prior). CONCLUSIONS: Significant positive associations between self-reported breakfast consumption and educational outcomes were observed. Future research should aim to explore the mechanisms by which breakfast consumption and educational outcomes are linked, and understand how to promote breakfast consumption among schoolchildren. Communicating findings of educational benefits to schools may help to enhance buy-in to efforts to improve health behaviours of pupils.

Identifying Well-Connected Opinion Leaders for Informal Health Promotion: The Example of the ASSIST Smoking Prevention Program.

Methods used to select opinion leaders for informal behavior change interventions vary, affecting the role they adopt and the outcomes of interventions. The development of successful identification methods requires evidence that these methods achieve their aims. This study explored whether the "whole community" nomination process used in the ASSIST smoking prevention program successfully identified "peer supporters" who were well placed within their school social networks to diffuse an antismoking message to their peers. Data were collected in the United Kingdom during A Stop Smoking in Schools Trial. Behavioral data were provided at baseline and post intervention by all students. Social network data were provided post intervention by students in four control and six intervention schools. Centrality measures calculated using UCINET demonstrate that the ASSIST nomination process successfully identified peer supporters who were more socially connected than others in their year and who had social connections across the entire year group including the program's target group. The results indicate that three simple questions can identify individuals who are held in high esteem by their year group and who also have the interpersonal networks required of opinion leaders to successfully disseminate smoke-free messages through their social networks. This approach could be used in other informal health promotion initiatives.

Electronic-cigarette use among young people in Wales: evidence from two cross-sectional surveys.

OBJECTIVES: To examine the prevalence of electronic(e)-cigarette use, prevalence of e-cigarette and tobacco use by age, and associations of e-cigarette use with sociodemographic characteristics, tobacco and cannabis use among young people in Wales. DESIGN: Data from two nationally-representative cross-sectional surveys undertaken in 2013-2014. Logistic regression analyses, adjusting for school-level clustering, examined sociodemographic characteristics of e-cigarette use, and associations between e-cigarette use and smoking. SETTING: Primary and secondary schools in Wales. PARTICIPANTS: Primary-school children aged 10-11 (n=1601) and secondary-school students aged 11-16 (n=9055). RESULTS: Primary-school children were more likely to have used e-cigarettes (5.8%) than tobacco (1.6%). Ever use of e-cigarettes remained more prevalent than ever use of tobacco until age 14-15. Overall, 12.3% of secondary-school students (aged 11-16) reported ever using e-cigarettes, with no differences according to gender, ethnicity or family affluence. The percentage of 'never smokers' reporting having used e-cigarettes was 5.3% at age 10-11 to 8.0% at age 15-16. The proportion of children who had ever used an e-cigarette and reported currently smoking increased from 6.9% among 10-11 year olds to 39.2% in 15-16 year olds. Only 1.5% (n=125) of 11-16 year-olds, including 0.3% of never smokers, reported regular e-cigarette use (use at least once a month). Current weekly smokers were 100 times more likely than non-smokers to report regular e-cigarette use (relative risk ratio (RRR=121.15; 95% CI 57.56 to 254.97). Regular e-cigarette use was also more likely among those who had smoked cannabis (RRR 53.03; 95% CI 38.87 to 80.65). CONCLUSIONS: Many young people (including never-smokers) have tried e-cigarettes. However, regular use is less common, and is associated with tobacco cigarette use. Longitudinal research is needed to understand age-related trajectories of e-cigarette use and to understand the temporal nature of relationships between e-cigarette and tobacco use.

Prevalence of smoking restrictions and child exposure to secondhand smoke in cars and homes: a repeated cross-sectional survey of children aged 10-11 years in Wales.

OBJECTIVE: Small increases in smoking restrictions in cars and homes were reported after legislation prohibiting smoking in public places. Few studies examine whether these changes continued in the longer term. This study examines changes in restrictions on smoking in cars and homes, and child exposure to secondhand smoke (SHS) in these locations, since 2008 postlegislation surveys in Wales. SETTING: State-maintained primary schools in Wales (n=75). PARTICIPANTS: Children aged 10-11 years (year 6) completed CHETS (CHild exposure to Environmental Tobacco Smoke) Wales surveys in 2007 (n=1612) and 2008 (n=1605). A replication survey (CHETS Wales 2) was conducted in 2014, including 1601 children. PRIMARY OUTCOME VARIABLE: Children's reports of whether smoking was allowed in their car or home and exposure to SHS in a car or home the previous day. RESULTS: The percentage of children who reported that smoking was allowed in their family vehicle fell from 18% to 9% in 2014 (OR=0.42; 95% CI 0.33 to 0.54). The percentage living in homes where smoking was allowed decreased from 37% to 26% (OR=0.30; 95% CI 0.20 to 0.43). Among children with a parent who smoked, one in five and one in two continued to report that smoking was allowed in their car and home. The percentage reporting SHS exposure in a car (OR=0.52; 95% CI 0.38 to 0.72) or home (OR=0.44; 95% CI 0.36 to 0.53) the previous day also fell. Children from poorer families remained less likely to report smoking restrictions. CONCLUSIONS: Smoking in cars and homes has continued to decline. Substantial numbers of children continue to report that smoking is allowed in cars and homes, particularly children from poorer families. A growing number of countries have legislated, or plan to legislate, banning smoking in cars carrying children. Attention is needed to the impact of legislation on child health and health inequalities, and reducing smoking in homes.