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.

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.

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.

Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services.

BACKGROUND: We have previously proposed that trials of social interventions can be done within a "realist" research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our philosophical position. METHODS: We set out to explore what is meant by positivism and whether trials adhere to its tenets (of necessity or in practice) via a narrative literature review of social science and philosophical discussions of positivism, and of the trials literature and three case studies of trials. RESULTS: The philosophical literature described positivism as asserting: (1) the epistemic primacy of sensory information; (2) the requirement that theoretical terms equate with empirical terms; (3) the aim of developing universal laws; and (4) the unity of method between natural and social sciences. Regarding (1), it seems that rather than embodying the epistemic primacy of sensory data, randomised controlled trials (RCTs) of social interventions in health embrace an anti-positivist approach aiming to test hypotheses derived deductively from prior theory. Considering (2), while some RCTs of social interventions appear to limit theorisation to concepts with empirical analogues, others examine interventions underpinned by theories engaging with mechanisms and contextual contingencies not all of which can be measured. Regarding (3), while some trialists and reviewers in the health field do limit their role to estimating statistical trends as a mechanistic form of generalisation, this is not an inevitable feature of RCT-based research. Trials of social interventions can instead aim to generalise at the level of theory which specifies how mechanisms are contingent on context. In terms of (4), while RCTs are used to examine biomedical as well as social interventions in health, RCTs of social interventions are often distinctive in using qualitative analyses of data on participant accounts to examine questions of meaning and agency not pursued in the natural sciences. CONCLUSION: We conclude that the most appropriate paradigm for RCTs of social interventions is realism not positivism.

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.

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.

A cross-sectional observational study of the nutritional intake of UK primary school children from deprived and non-deprived backgrounds: implications for school breakfast schemes.

BACKGROUND: This study examined the nutritional intake of 9-11 year old children in Wales, UK, to assess the rationale for, and potential of, school breakfast initiatives. It also examined the possible unintended consequence of over consumption. METHODS: The study employed a cross-sectional observational design within a randomized controlled trial of a free school breakfast programme. A total of 111 primary schools were randomly assigned to an intervention condition (in which a free school breakfast programme was implemented) or a control condition (in which implementation of the scheme was delayed). Sub-samples of children completed multiple-pass 24-hr dietary recall interviews at baseline (n = 581), and 12 months later (n = 582). Deprivation was assessed for each child in terms of whether or not they were entitled to free school meals. RESULTS: Prior to the introduction of the programme, rates of breakfast skipping were low and there was little evidence of widespread nutritional deficiency. However, there was a subset of children who consumed inadequate levels of a range of vitamins and minerals and 29 % of children ate very little for breakfast (less than 100 kcal). Children that ate larger breakfasts, had higher daily intakes of all nutrients that were examined. Children from deprived backgrounds consumed significantly lower levels of several vitamins and minerals at breakfast. Following the introduction of the breakfast scheme in intervention schools, there was little difference in the nutritional quality of school versus home breakfasts (n = 35 and 211 respectively). Where children ate breakfast at both school and home (n = 33), their overall energy intake was higher, but not significantly so. CONCLUSIONS: Although the overall diet of this group of children was generally good prior to the breakfast scheme, the results suggest that such schemes could be beneficial for a subset of children who are poorly nourished and for those children who consume very little for breakfast. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18336527.

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.

Psychosocial mediators of change in physical activity in the Welsh national exercise referral scheme: secondary analysis of a randomised controlled trial.

OBJECTIVE: While an increasing number of randomised controlled trials report impacts of exercise referral schemes (ERS) on physical activity, few have investigated the mechanisms through which increases in physical activity are produced. This study examines whether a National Exercise Referral Scheme (NERS) in Wales is associated with improvements in autonomous motivation, self-efficacy and social support, and whether change in physical activity is mediated by change in these psychosocial processes. METHODS: A pragmatic randomised controlled trial of NERS across 12 LHBs in Wales. Questionnaires measured demographic data and physical activity at baseline. Participants (N = 2160) with depression, anxiety or CHD risk factors were referred by health professionals and randomly assigned to control or intervention. At six months psychological process measures were collected by questionnaire. At 12 months physical activity was assessed by 7 Day PAR telephone interview. Regressions tested intervention effects on psychosocial variables, physical activity before and after adjusting for mediators and socio demographic patterning. RESULTS: Significant intervention effects were found for autonomous motivation and social support for exercise at 6 months. No intervention effect was observed for self-efficacy. The data are consistent with a hypothesis of partial mediation of the intervention effect by autonomous motivation. Analysis of moderators showed significant improvements in relative autonomy in all subgroups. The greatest improvements in autonomous motivation were observed among patients who were least active at baseline. DISCUSSION: The present study offered key insights into psychosocial processes of change in an exercise referral scheme, with effects on physical activity mediated by autonomous motivation. Findings support the use of self-determination theory as a framework for ERS. Further research is required to explain socio-demographic patterning in responses to ERS, with changes in motivation occurring among all sub-groups of participants, though not always leading to higher adherence or behavioural change. This highlights the importance of socio-ecological approaches to developing and evaluating behaviour change interventions, which consider factors beyond the individual, including conditions in which improved motivation does or does not produce behavioural change. TRIAL REGISTER NUMBER: ISRCTN47680448.

Impacts of the Primary School Free Breakfast Initiative on socio-economic inequalities in breakfast consumption among 9-11-year-old schoolchildren in Wales.

OBJECTIVES: Universal interventions may widen or narrow inequalities if disproportionately effective among higher or lower socio-economic groups. The present paper examines impacts of the Primary School Free Breakfast Initiative in Wales on inequalities in children's dietary behaviours and cognitive functioning. DESIGN: Cluster-randomised controlled trial. Responses were linked to free school meal (FSM) entitlement via the Secure Anonymised Information Linkage databank. Impacts on inequalities were evaluated using weighted school-level regression models with interaction terms for intervention × whole-school percentage FSM entitlement and intervention × aggregated individual FSM entitlement. Individual-level regression models included interaction terms for intervention × individual FSM entitlement. SETTING: Fifty-five intervention and fifty-six wait-list control primary schools. SUBJECTS: Approximately 4500 children completed measures of dietary behaviours and cognitive tests at baseline and 12-month follow-up. RESULTS: School-level models indicated that children in intervention schools ate a greater number of healthy items for breakfast than children in control schools (b = 0·25; 95 % CI 0·07, 0·44), with larger increases observed in more deprived schools (interaction term b = 1·76; 95 % CI 0·36, 3·16). An interaction between intervention and household-level deprivation was not significant. Despite no main effects on breakfast skipping, a significant interaction was observed, indicating declines in breakfast skipping in more deprived schools (interaction term b = -0·07; 95 % CI -0·15, -0·00) and households (OR = 0·67; 95 % CI 0·46, 0·98). No significant influence on inequality was observed for the remaining outcomes. CONCLUSIONS: Universal breakfast provision may reduce socio-economic inequalities in consumption of healthy breakfast items and breakfast skipping. There was no evidence of intervention-generated inequalities in any outcomes.

All-Wales licensed premises intervention (AWLPI): a randomised controlled trial to reduce alcohol-related violence.

BACKGROUND: Alcohol-related violence in and in the vicinity of licensed premises continues to place a considerable burden on the United Kingdom's (UK) health services. Robust interventions targeted at licensed premises are therefore required to reduce the costs of alcohol-related harm. Previous evaluations of interventions in licensed premises have a number of methodological limitations and none have been conducted in the UK. The aim of the trial was to determine the effectiveness of the Safety Management in Licensed Environments intervention designed to reduce alcohol-related violence in licensed premises, delivered by Environmental Health Officers, under their statutory authority to intervene in cases of violence in the workplace. METHODS/DESIGN: A national randomised controlled trial, with licensed premises as the unit of allocation. Premises were identified from all 22 Local Authorities in Wales. Eligible premises were those with identifiable violent incidents on premises, using police recorded violence data. Premises were allocated to intervention or control by optimally balancing by Environmental Health Officer capacity in each Local Authority, number of violent incidents in the 12 months leading up to the start of the project and opening hours. The primary outcome measure is the difference in frequency of violence between intervention and control premises over a 12 month follow-up period, based on a recurrent event model. The trial incorporates an embedded process evaluation to assess intervention implementation, fidelity, reach and reception, and to interpret outcome effects, as well as investigate its economic impact. DISCUSSION: The results of the trial will be applicable to all statutory authorities directly involved with managing violence in the night time economy and will provide the first formal test of Health and Safety policy in this environment. If successful, opportunities for replication and generalisation will be considered. TRIAL REGISTRATION: UKCRN 14077; ISRCTN78924818.

Preventing substance misuse: study protocol for a randomised controlled trial of the Strengthening Families Programme 10-14 UK (SFP 10-14 UK).

BACKGROUND: Prevention of alcohol, drug and tobacco misuse by young people is a key public health priority. There is a need to develop the evidence base through rigorous evaluations of innovative approaches to substance misuse prevention. The Strengthening Families Programme 10-14 is a universal family-based alcohol, drugs and tobacco prevention programme, which has achieved promising results in US trials, and which now requires cross-cultural assessment. This paper therefore describes the protocol for a randomised controlled trial of the UK version of the Strengthening Families Programme 10-14 (SFP 10-14 UK). METHODS/DESIGN: The trial comprises a pragmatic cluster randomised controlled effectiveness trial with families as the unit of randomisation, with embedded process and economic evaluations. Participating families will be randomised to one of two treatment groups - usual care with full access to existing services (control group), or usual care plus SFP 10-14 UK (intervention group). The trial has two primary outcomes - the number of occasions that young people report having drunk alcohol in the last 30 days, and drunkenness during the last 30 days, both dichotomised as 'never' and '1-2 times or more'. The main follow-up is at 2 years past baseline, and short-term and intermediate outcomes are also measured at 9 and 15 months. DISCUSSION: The results from this trial will provide evidence on the effectiveness and cost-effectiveness of an innovative universal family-based substance misuse prevention programme in a UK context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN63550893.

Exploring subgroup effects by socioeconomic position of three effective school-based dietary interventions: the European TEENAGE project.

OBJECTIVES: The aim of this study was to explore subgroup effects by high and low socioeconomic position (SEP) of three previously conducted, effective European interventions. METHODS: Reanalyses stratified by SEP were conducted by the research groups of each study. All studies were school-based: two multi-component interventions targeting intake of fat or fruit and vegetables (FV), and a free breakfast initiative. RESULTS: Computer-tailored advice affected fat intake among low, but not high SEP girls after 1 year. A multi-component intervention affected the total FV intake in both SEP groups, vegetable intake in low SEP and fruit intake in high SEP across three countries after 1 year, whereas free fruit affected total FV and fruit intake equally in both SEP groups in one country after 2 years. Providing a free healthy breakfast increased consumption of healthy food items only in the low SEP group. CONCLUSIONS: Reanalysing intervention studies by SEP is a quick and easy way to explore patterns in effects by SEP across interventions. Providing healthy food might be a promising strategy for decreasing social inequalities.

Cost-effectiveness of a national exercise referral programme for primary care patients in Wales: results of a randomised controlled trial.

BACKGROUND: A recent HTA review concluded that there was a need for RCTs of exercise referral schemes (ERS) for people with a medical diagnosis who might benefit from exercise. Overall, there is still uncertainty as to the cost-effectiveness of ERS. Evaluation of public health interventions places challenges on conventional health economics approaches. This economic evaluation of a national public health intervention addresses this issue of where ERS may be most cost effective through subgroup analysis, particularly important at a time of financial constraint. METHOD: This economic analysis included 798 individuals aged 16 and over (55% of the randomised controlled trial (RCT) sample) with coronary heart disease risk factors and/or mild to moderate anxiety, depression or stress. Individuals were referred by health professionals in a primary care setting to a 16 week national exercise referral scheme (NERS) delivered by qualified exercise professionals in local leisure centres in Wales, UK. Health-related quality of life, health care services use, costs per participant in NERS, and willingness to pay for NERS were measured at 6 and 12 months. RESULTS: The base case analysis assumed a participation cost of £385 per person per year, with a mean difference in QALYs between the two groups of 0.027. The incremental cost-effectiveness ratio was £12,111 per QALY gained. Probabilistic sensitivity analysis demonstrated an 89% probability of NERS being cost-effective at a payer threshold of £30,000 per QALY. When participant payments of £1 and £2 per session were considered, the cost per QALY fell from £12,111 (base case) to £10,926 and £9,741, respectively. Participants with a mental health risk factor alone or in combination with a risk of chronic heart disease generated a lower ICER (£10,276) compared to participants at risk of chronic heart disease only (£13,060). CONCLUSIONS: Results of cost-effectiveness analyses suggest that NERS is cost saving in fully adherent participants. Though full adherence to NERS (62%) was higher for the economics sample than the main sample (44%), results still suggest that NERS can be cost-effective in Wales with respect to existing payer thresholds particularly for participants with mental health and CHD risk factors. TRIAL REGISTRATION: Current Controlled Trials ISRCTN47680448.

Training practitioners to deliver opportunistic multiple behaviour change counselling in primary care: a cluster randomised trial.

OBJECTIVES: To evaluate the effect of training primary care health professionals in behaviour change counselling on the proportion of patients self reporting change in four risk behaviours (smoking, alcohol use, exercise, and healthy eating). DESIGN: Cluster randomised trial with general practices as the unit of randomisation. SETTING: General practices in Wales. PARTICIPANTS: 53 general practitioners and practice nurses from 27 general practices (one each at all but one practice) recruited 1827 patients who screened positive for at least one risky behaviour. INTERVENTION: Behaviour change counselling was developed from motivational interviewing to enable clinicians to enhance patients' motivation to change health related behaviour. Clinicians were trained using a blended learning programme called Talking Lifestyles. MAIN OUTCOME MEASURES: Proportion of patients who reported making beneficial changes in at least one of the four risky behaviours at three months. RESULTS: 1308 patients from 13 intervention and 1496 from 14 control practices were approached: 76% and 72% respectively agreed to participate, with 831 (84%) and 996 (92%) respectively screening eligible for an intervention. There was no effect on the primary outcome (beneficial change in behaviour) at three months (362 (44%) v 404 (41%), odds ratio 1.12 (95% CI 0.90 to 1.39)) or on biochemical or biometric measures at 12 months. More patients who had consulted with trained clinicians recalled consultation discussion about a health behaviour (724/795 (91%) v 531/966 (55%), odds ratio 12.44 (5.85 to 26.46)) and intended to change (599/831 (72%) v 491/996 (49%), odds ratio 2.88 (2.05 to 4.05)). More intervention practice patients reported making an attempt to change (328 (39%) v 317 (32%), odds ratio 1.40 (1.15 to 1.70)), a sustained behaviour change at three months (288 (35%) v 280 (28%), odds ratio 1.36 (1.11 to 1.65)), and reported slightly greater improvements in healthy eating at three and 12 months, plus improved activity at 12 months. Training cost £1597 per practice. DISCUSSION: Training primary care clinicians in behaviour change counselling using a brief blended learning programme did not increase patients reported beneficial behaviour change at three months or improve biometric and a biochemical measure at 12 months, but it did increase patients' recollection of discussing behaviour change with their clinicians, intentions to change, attempts to change, and perceptions of having made a lasting change at three months. Enduring behaviour change and improvements in biometric measures are unlikely after a single routine consultation with a clinician trained in behaviour change counselling without additional intervention. TRIAL REGISTRATION: ISRCTN 22495456.

An evaluation of the effectiveness and cost effectiveness of the National Exercise Referral Scheme in Wales, UK: a randomised controlled trial of a public health policy initiative.

BACKGROUND: The Wales National Exercise Referral Scheme (NERS) is a 16-week programme including motivational interviewing, goal setting and relapse prevention. METHOD: A pragmatic randomised controlled trial with nested economic evaluation of 2160 inactive participants with coronary heart disease risk (CHD, 1559, 72%), mild to moderate depression, anxiety or stress (79, 4%) or both (522, 24%) randomised to receive (1) NERS or (2) normal care and brief written information. Outcome measures at 12 months included the 7-day physical activity recall, the hospital anxiety and depression scale. RESULTS: Ordinal regression identified increased physical activity among those randomised to NERS compared with those receiving normal care in all participants (OR 1.19, 95% CI 0.99 to 1.43), and among those referred for CHD only (OR 1.29, 95% CI 1.04 to 1.60). For those referred for mental health reason alone, or in combination with CHD, there were significantly lower levels of anxiety (-1.56, [corrected] 95% CI -2.75 to -0.38) and depression (-1.39, [corrected] 95% CI -2.60 to -0.18), but no effect on physical activity. The base-case incremental cost-effectiveness ratio was £12,111 per quality adjusted life year, falling to £9741 if participants were to contribute £2 per session. CONCLUSIONS: NERS was effective in increasing physical activity among those referred for CHD risk only. Among mental health referrals, NERS did not influence physical activity but was associated with reduced anxiety and depression. Effects were dependent on adherence. NERS is likely to be cost effective with respect to prevailing payer thresholds. Trial registration Current Controlled Trials ISRCTN47680448.

Socioeconomic inequalities in childhood exposure to secondhand smoke before and after smoke-free legislation in three UK countries.

BACKGROUND: Secondhand smoke (SHS) exposure is higher among lower socioeconomic status (SES) children. Legislation restricting smoking in public places has been associated with reduced childhood SHS exposure and increased smoke-free homes. This paper examines socioeconomic patterning in these changes. METHODS: Repeated cross-sectional survey of 10 867 schoolchildren in 304 primary schools in Scotland, Wales and Northern Ireland. Children provided saliva for cotinine assay, completing questionnaires before and 12 months after legislation. RESULTS: SHS exposure was highest, and private smoking restrictions least frequently reported, among lower SES children. Proportions of saliva samples containing <0.1 ng/ml (i.e. undetectable) cotinine increased from 31.0 to 41.0%. Although across the whole SES spectrum, there was no evidence of displacement of smoking into the home or increased SHS exposure, socioeconomic inequality in the likelihood of samples containing detectable levels of cotinine increased. Among children from the poorest families, 96.9% of post-legislation samples contained detectable cotinine, compared with 38.2% among the most affluent. Socioeconomic gradients at higher exposure levels remained unchanged. Among children from the poorest families, one in three samples contained >3 ng/ml cotinine. Smoking restrictions in homes and cars increased, although socioeconomic patterning remained. CONCLUSIONS: Urgent action is needed to reduce inequalities in SHS exposure. Such action should include emphasis on reducing smoking in cars and homes.