Effect of 3 months and 12 months of financial incentives on 12-month postpartum smoking cessation maintenance: A randomized controlled trial.

BACKGROUND AND AIMS: Offering financial incentives is effective for smoking cessation during pregnancy. We tested the effectiveness of financial incentives for maintaining postpartum cessation, comparing 12-month and 3-month incentives with each other and with usual care (UC). DESIGN, SETTING AND PARTICIPANTS: This study was a pragmatic, multi-centre, three-arm randomized controlled trial involving four English, National Health Service, stop smoking services. A total of 462 postpartum women (aged ≥ 16 years) took part, who stopped smoking during pregnancy with financial incentives, validated as abstinent from smoking at end of pregnancy or early postpartum. INTERVENTIONS: Interventions comprised (i) UC; (ii) UC plus up to £60 of financial voucher incentives offered to participants and £60 offered to an optional significant-other supporter, over 3 months postpartum, contingent upon validated abstinence ('3-month incentives'); or (iii) UC plus '3-month incentives' plus £180 of vouchers offered to participants over 9 months postpartum, contingent upon abstinence ('12-month incentives'). MEASUREMENTS: Primary outcome: biochemically validated abstinence at 1 year postpartum. To adjust for testing all comparisons between groups with equal precision, P < 0.017 was necessary for significance. SECONDARY OUTCOMES: self-reported and validated abstinence at 3 months postpartum; self-reported abstinence at 1 year postpartum. FINDINGS: Primary outcome ascertainment: abstinence was 39.6% (63/159) 12 months incentives, 21.4% (33/154) 3 months incentives and 28.2% (42/149) UC. Adjusted odds ratios [95% confidence interval (CI)] = 12-month versus 3-month incentives OR = 2.41 (95% CI = 1.46-3.96), P = 0.001; 12 months versus UC 1.67 (1.04-2.70), P = 0.035; 3 months versus UC 0.69 (0.41-1.17), P = 0.174. Bayes factors indicated that for 12-month versus 3-month incentives and 12 months versus UC there was good evidence for the alternative hypothesis, and for 3 months versus UC there was good evidence for the null hypothesis. CONCLUSIONS: This randomized controlled trial provides weak evidence that up to £300 of voucher incentives over 12 months is effective for maintaining smoking abstinence postpartum compared with usual care. There was good evidence that 12-month incentives are superior to those over only 3 months, for which there was no evidence of effectiveness relative to usual care.

Impacts of EU Tobacco Products Directive regulations on use of e-cigarettes in adolescents in Great Britain: a natural experiment evaluation.

Background: E-cigarettes are a popular smoking-cessation tool. Although less harmful than tobacco, use of e-cigarettes by non-smokers should be prevented. There is concern about the use of e-cigarettes by young people and that e-cigarettes may renormalise smoking. In May 2016, Tobacco Products Directive regulations aimed to reduce e-cigarettes' appeal to young people. Aims: To examine the effects of the Tobacco Products Directive regulations on young people's use of e-cigarettes, and the role of e-cigarettes in renormalising smoking. Design: A mixed-method natural experimental evaluation combining secondary analyses of survey data, with process evaluation, including interviews with young people, policy stakeholders, retailers and trading standards observers, and observations of retail settings. Settings: Wales, Scotland and England. Participants: Survey participants were aged 13-15 years, living in England, Scotland or Wales and participated in routinely conducted surveys from 1998 to 2019. Process evaluation participants included 14- to 15-year-olds in England, Scotland and Wales, policy stakeholders, trading standards offices and retailers. Intervention: Regulation of e-cigarettes, including bans on cross-border advertising, health warnings and restrictions on product strength. Comparison group: Interrupted time series design, with baseline trends as the comparator. Main outcome measures: The primary outcome was ever e-cigarette use. Secondary outcomes included regular use, ever and regular smoking, smoking attitudes, alcohol and cannabis use. Data capture and analysis: Our primary statistical analysis used data from Wales, including 91,687 young people from the 2013-19 Health Behaviour in School-aged Children and School Health Research Network surveys. In Scotland, we used the Scottish Schools Adolescent Lifestyle and Substance Use Survey and in England we used the Smoking Drinking and Drug Use surveys. The process evaluation included interviews with 73 young people in 2017 and 148 young people in 2018, 12 policy stakeholders, 13 trading standards officers and 27 retailers. We observed 30 retail premises before and after implementation. Data were integrated using the Medical Research Council's process evaluation framework. Results: Ever smoking continued to decline alongside the emergence of e-cigarettes, with a slight slowing in decline for regular use. Tobacco Products Directive regulations were described by stakeholders as well implemented, and observations indicated good compliance. Young people described e-cigarettes as a fad and indicated limited interaction with the components of the Tobacco Products Directive regulations. In primary statistical analyses in Wales [i.e. short (to 2017) and long term (to 2019)], growth in ever use of e-cigarettes prior to Tobacco Products Directive regulations did not continue after implementation. Change in trend was significant in long-term analysis, although of similar magnitude at both time points (odds ratio 0.96). Data from England and Scotland exhibited a similar pattern. Smoking followed the opposite pattern, declining prior to the Tobacco Products Directive regulations, but plateauing as growth in e-cigarette use stalled. Limitations: Alternative causal explanations for changes cannot be ruled out because of the observational design. Conclusions: Young people's ever and regular use of e-cigarettes appears to have peaked around the time of the Tobacco Products Directive regulations and may be declining. Although caution is needed in causal attributions, findings are consistent with an effect of regulations. Our analysis provides little evidence that e-cigarettes renormalise smoking. More recent data indicate that declines in smoking are plateauing. Future work: International comparative work to understand differences in use of e-cigarettes, and tobacco, within varying regulatory frameworks is a priority. Study registration: This study is registered as ResearchRegistry4336. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 11, No. 5. See the NIHR Journals Library website for further project information.

Much has been achieved in preventing young people smoking; however, e-cigarettes have emerged as a new issue. E-cigarettes can help smokers stop, but might also appeal to young people or make smoking look 'normal'. Until recently, In the United Kingdom, there were not many rules for e-cigarettes. In 2016, new rules came in as part of the European Union Tobacco Products Directive regulations. The Tobacco Products Directive regulations limited advertising and included rules about how e-cigarettes should be labelled. In our study, we wanted to know if (1) e-cigarettes make young people think smoking is 'normal' and (2) people's use of e-cigarettes changed after new rules. We included young people who took part in surveys in England, Scotland and Wales between 1998 and 2019. Overall, about 360,000 young people did one of the surveys and about 90,000 were included in our main analysis. We spoke with young people in 2017 and 2018. In addition, in 2018, we spoke with people involved in tobacco policy, trading standards officers and people who sold e-cigarettes. Young people held negative attitudes about smoking and said that friends disagreed with smoking. Young people approved of occasional social e-cigarette use, but not regular use. Stakeholders described a range of views on how e-cigarettes should be regulated. Retailers and trading standards officers said that some retailers did not get much information about Tobacco Products Directive regulations, but new rules were implemented well. The percentage of young people saying that they had tried e-cigarettes was growing, but the number had stopped growing after the new rules. Regular use remained low throughout. Our findings suggest that e-cigarettes are not making smoking look normal again and new rules may have helped stop growth in use of e-cigarettes by young people.

Response to a novel, weight self-awareness plan used in a multi-component lifestyle intervention programme to reduce breast cancer risk factors in older women-Secondary analysis from the ActWELL trial.

BACKGROUND: The ActWELL randomised controlled trial assessed the effectiveness of a weight management programme delivered by volunteer lifestyle coaches (LCs) in women attending breast clinics. The intervention focused on caloric intake and physical activity, utilising behavioural change techniques including a weight awareness plan (WAP). The current work is a secondary analysis of the ActWELL data and aims to examine the response to the weight self-awareness plan (used as part of the intervention programme). METHODS: The LCs invited participants (n = 279) to undertake an implementation intention discussion to formulate a self-weighing (SW) plan. Bodyweight scales were offered, and recording books provided. The physical activity component of the intervention focused on a walking plan assessed by accelerometers. The LCs contacted participants by telephone monthly and provided personalised feedback. Mann-Whitney tests and chi-squared analysis were used to examine the effect of SW on weight change. A qualitative evaluation utilising semi-structured interviews was also undertaken. RESULTS: Most participants (96.4%) agreed to set a weekly SW goal and 76 (27%) requested scales. At 12 months, 226 (81%) returned for follow up. The median (interquartile range) weight change for those who self- reported at least one weight (n = 211) was -2.3 kg (-5.0 to 0.0) compared to -1.2 kg (-5.0 to 0.03) in those who did not (n = 14). Participants who reported weights on more than eight occasions (39%) were significantly more likely (p = 0.012) to achieve 5% weight loss compared to those who weighed less often. Low numbers of accelerometers were returned that did not allow for significance testing. Qualitative data (n = 24) indicated that many participants found the WAP helpful and motivating. CONCLUSIONS: Greater adherence to the WAP initiated by volunteer coaches is associated with achieving 5% weight loss.

Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial.

OBJECTIVE: To examine effectiveness, cost effectiveness, generalisability, and acceptability of financial incentives for smoking cessation during pregnancy in addition to variously organised UK stop smoking services. DESIGN: Pragmatic, multicentre, single blinded, phase 3, randomised controlled trial (Cessation in Pregnancy Incentives Trial phase 3 (CPIT III)). SETTING: Seven UK stop smoking services provided in primary and secondary care facilities in Scotland, Northern Ireland, and England. PARTICIPANTS: 944 pregnant women (age ≥16 years) who self-reported as being smokers (at least one cigarette in the past week) when asked at first maternity visit, less than 24 weeks' gestation, and notified to the trial team by routine stop smoking services. INTERVENTIONS: Participants in the control group were offered the standard stop smoking services, which includes the offer of counselling by specially trained workers using withdrawal orientated therapy and the offer of free nicotine replacement therapy. The intervention was the offer of usual support from the stop smoking services and the addition of up to £400 ($440; €455) of LoveToShop financial voucher incentives for engaging with current stop smoking services or to stop smoking, or both, during pregnancy. MAIN OUTCOME MEASURES: Self-reported smoking cessation in late pregnancy (between 34 and 38 weeks' gestation) corroborated by saliva cotinine (and anabasine if using nicotine replacement products). Results were adjusted for age, smoking years, index of multiple deprivation, Fagerström score, before or after covid, and recruitment site. Secondary outcomes included point and continuous abstinence six months after expected date of delivery, engagement with stop smoking services, biochemically validated abstinence from smoking at four weeks after stop smoking date, birth weight of baby, cost effectiveness, generalisability documenting formats of stop smoking services, and acceptability to pregnant women and their carers. RESULTS: From 9 January 2018 to 4 April 2020, of 4032 women screened by stop smoking services, 944 people were randomly assigned to the intervention group (n=471) or the control group (n=470). Three people asked for their data to be removed. 126 (27%) of 471 participants stopped smoking from the intervention group and 58 (12%) of 470 from the control group (adjusted odds ratio 2.78 (1.94 to 3.97) P<0.001). Serious adverse events were miscarriages and other expected pregnancy events requiring hospital admission; all serious adverse events were unrelated to the intervention. Most people who stopped smoking from both groups relapsed after their baby was born. CONCLUSIONS: The offer of up to £400 of financial voucher incentives to stop smoking during pregnancy as an addition to current UK stop smoking services is highly effective. This bolt-on intervention supports new guidance from the UK National Institute for Health and Care Excellence, which includes the addition of financial incentives to support pregnant women to stop smoking. Continuing incentives to 12 months after birth is being examined to prevent relapse. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15236311.

Usual care in a multicentre randomised controlled trial of financial incentives for smoking cessation in pregnancy: qualitative findings from a mixed-methods process evaluation.

OBJECTIVES: Financial incentives are recommended by the UK's National Institute for Health and Care Excellence to aid smoking cessation in pregnancy. However, little is known about how implementation contexts might impact on their effectiveness. Variations in smoking cessation support (usual care) for pregnant women who smoke were examined qualitatively as part of a prospective process evaluation of the Cessation in Pregnancy Incentives Trial (CPIT III). DESIGN: Longitudinal case studies of five CPIT III trial sites informed by realist evaluation. SETTING: A stop smoking service (SSS) serving a maternity hospital constituted each case study, located in three UK countries. PARTICIPANTS: Data collection included semistructured interviews with trial participants (n=22), maternity (n=12) and SSS staff (n=17); and site observations and perspectives recorded in fieldnotes (n=85). RESULTS: Cessation support (usual care) for pregnant women varied in amount, location, staff capacity, flexibility and content across sites. SSS staff capacity was important to avoid gaps in support. Colocation and good working relationships between maternity and SSS professionals enabled prioritisation and reinforced the importance of smoking cessation. Sites with limited use of carbon monoxide (CO) monitoring reduced opportunities to identify smokers while inconsistency around automatic referral processes prevented the offer of cessation support. SSS professionals colocated within antenatal clinics were available to women they could not otherwise reach. Flexibility around location, timing and tailoring of approaches for support, facilitated initial and sustained engagement and reduced the burden on women. CONCLUSIONS: Trial sites faced varied barriers and facilitators to delivering cessation support, reflecting heterogeneity in usual care. If financial incentives are more effective with concurrent smoking cessation support, sites with fewer barriers and more facilitators regarding this support would be expected to have more promising trial outcomes. Future reporting of trial outcomes will assist in understanding incentives' generalisability across a wide range of usual care settings. TRIAL REGISTRATION NUMBER: ISRCTN15236311.

Implementation of e-cigarette regulation through the EU Tobacco Products Directive (2016) in Wales, Scotland and England from the perspectives of stakeholders involved in policy introduction and enforcement.

INTRODUCTION: From May 2016, the European Union introduced the Tobacco Products Directive (TPD) regulations, which included restrictions to advertising and new safety and labeling standards for e-cigarette products. This represented the first supranational policy regulating e-cigarette sales and marketing. This study explores perceptions of TPD and its implementation in Wales, Scotland and England, from perspectives of stakeholders involved in tobacco and e-cigarette policy and implementation in each nation. METHODS: Semi-structured qualitative interviews were completed with 12 stakeholders from government and third sector organizations in the UK involved in tobacco control policy-making processes, and Trading Standards Officers from 13 UK local authorities. Data were analyzed thematically and a sub-sample double-coded. RESULTS: Stakeholders held varying views of e-cigarettes, recognizing potential benefits and harms of both the products and the new policy actions. Nevertheless, most perceived TPD to be a positive step in introducing regulation for e-cigarettes. Compliance was perceived as high across nations, although stakeholders highlighted product adaptations to circumvent restrictions, and absence of controls on non-nicotine products. Budgetary and staffing limitations also meant that capacity to communicate new measures, and enforce change, was limited. This led to a gap occupied by industry representatives, who played a substantial role in preparing retailers for adoption of new measures. CONCLUSIONS: TPD policy roll-out was largely perceived positively and as having been effectively implemented. However, contribution of industry to communication of new measures and absence of resourcing for effective communication perhaps introduced widespread innovations within regulations. While largely viewed positively, some refinements to device regulations were proposed.

A novel approach to increasing community capacity for weight management a volunteer-delivered programme (ActWELL) initiated within breast screening clinics: a randomised controlled trial.

BACKGROUND: It is estimated that around 30% of breast cancers in post-menopausal women are related to lifestyle. The breast cancer-pooling project demonstrated that sustained weight loss of 2 to 4.5 kg is associated with an 18% lower risk of breast cancer, highlighting the importance of small changes in body weight. Our study aimed to assess the effectiveness a volunteer-delivered, community based, weight management programme (ActWELL) for women with a BMI > 25 kg/m2 attending NHS Scotland Breast Screening clinics. METHODS: A multicentre, 1:1 parallel group, randomised controlled trial was undertaken in 560 women aged 50 to 70 years with BMI > 25 kg/m2. On completion of baseline measures, all participants received a breast cancer prevention leaflet. Intervention group participants received the ActWELL intervention which focussed on personalised diet advice and pedometer walking plans. The programme was delivered in leisure centres by (the charity) Breast Cancer Now volunteer coaches. Primary outcomes were changes between groups at 12 months in body weight (kg) and physical activity (accelerometer measured step count). RESULTS: Two hundred seventy-nine women were allocated to the intervention group and 281 to the comparison group. Twelve-month data were available from 240 (81%) intervention and 227 (85%) comparison group participants. Coaches delivered 523 coaching sessions and 1915 support calls to 279 intervention participants. Mean weight change was - 2.5 kg (95% CI - 3.1 to - 1.9) in the intervention group and - 1.2 kg (- 1.8 to 0.6) in the comparison group. The adjusted mean difference was - 1.3 kg (95% CI - 2.2 to - 0.4, P = 0.003). The odds ratio for losing 5% weight was 2.20 (95% CI 1.4 to 3.4, p = 0.0005) in favour of the intervention. The adjusted mean difference in step counts between groups was 483 steps/day (95% CI - 635 to 1602) (NS). CONCLUSIONS: A community weight management intervention initiated at breast screening clinics and delivered by volunteer coaches doubled the likelihood of clinically significant weight loss at 12 months (compared with usual care) offering significant potential to decrease breast cancer risk. TRIAL REGISTRATION: Database of registration: ISCRTN. Registration number: 11057518 . Date trial registered:21.07.2017. Date of enrolment of first participant: 01.09.2017.

Extending health messaging to the consumption experience: a focus group study exploring smokers' perceptions of health warnings on cigarettes.

Introduction: While most countries require health warnings on cigarette packs, the Scottish and Canadian Governments are considering requiring health warnings on cigarette sticks. Methods: Twenty focus groups were conducted in Glasgow and Edinburgh (Scotland) with smokers (n = 120) segmented by age (16-17, 18-24, 25-35, 36-50, >50), gender and social grade, to explore perceptions of cigarettes displaying the warning 'Smoking kills' on the cigarette paper and any demographic differences in how smokers responded to these. Results: A warning on each cigarette was thought to prolong the health message, as it would be visible when a cigarette was taken from a pack, lit, left in an ashtray, and with each draw, and make avoidant behavior more difficult. That it would be visible to others was perceived as off-putting for some. It was felt that a warning on each cigarette would create a negative image and be embarrassing. Within several female groups they were viewed as depressing, worrying and frightening, with it suggested that people would not feel good smoking cigarettes displaying a warning. Within every group there was mention of warnings on cigarettes potentially having an impact on themselves, others or both. Some, mostly younger groups, mentioned stubbing cigarettes out early, reducing consumption or quitting. The consensus was that they would be off-putting for young people, nonsmokers and those starting to smoke. Conclusions: Including a warning on each cigarette stick is a viable policy option and one which would, for the first time, extend health messaging to the consumption experience.

Young people's use of e-cigarettes in Wales, England and Scotland before and after introduction of EU Tobacco Products Directive regulations: a mixed-method natural experimental evaluation.

BACKGROUND: Young people's experimentation with e-cigarettes has increased in recent years, although regular use remains limited. EU Tobacco Products Directive (TPD) regulations introduced packet warnings, advertising restrictions, and regulated nicotine strength from 2016, in part due to concerns regarding use by young people. This paper examines e-cigarette use trajectories before and after TPD. METHODS: E-cigarette use data were obtained from School Health Research Network/Health Behaviour in School-aged Children surveys in Wales and Smoking Drinking and Drug Use surveys in England. Data from Wales were analysed using segmented logistic regression, with before and after regression analyses of English data. Semi-structured group interviews included young people aged 14-16 years in Wales, England and Scotland in 2017 and 2018. RESULTS: In Wales, ever use of e-cigarettes increased over time, but under a range of assumptions, growth did not appear to continue post-TPD. A small and non-significant change in trend was observed post-implementation (OR=0.96; 95%CI=0.91 to 1.01), which increased in size and significance after adjusting for ever smoking (OR=0.93; 95%CI=0.88 to 0.98). There was little increase in regular e-cigarette use from 2015 to 2017 in Wales. However, ever and regular use increased from 2014 to 2016 in England. Young people in all nations described limited interactions with components of TPD, while describing e-cigarette use as a 'fad', which had begun to run its course. CONCLUSIONS: This study provides preliminary evidence that young people's e-cigarette experimentation may be plateauing in UK nations. The extent to which this arises from regulatory changes, or due to a fad having begun to lose its appeal among young people in the UK countries, remains unclear. These trends contrast to those observed in North America, where newer products whose EU market entry and marketing have been impacted by TPD, have gained traction among young people. Long-term monitoring of e-cigarette use trends and perceptions among young people remain vital.

Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics.

BACKGROUND: Around 30% of post-menopausal breast cancer is related to excess body fat, alcohol intake and low levels of physical activity. Current estimates suggest that there is a 12% increased risk in post-menopausal breast cancer for every 5 kg/m2 increase in body mass index (BMI). Despite this evidence there are few lifestyle programmes directed towards breast cancer risk reduction. This paper describes the process of optimising of the ActWELL programme which aims to support weight management in women invited to attend routine National Health Service (NHS) breast screening clinics. METHODS: A feasibility study of a prototype programme aiming to change lifestyle behaviours was successfully undertaken. The programme used educational approaches and behaviour change techniques delivered by lifestyle coaches using individual face to face meetings and telephone sessions. To optimise the intervention for a definitive randomised controlled trial of weight management, data from the feasibility trial, focus group discussions conducted with the target population, feedback from the trial public advisory group and comments from peer reviewers were obtained. Concepts from implementation research provided further guidance to assist in the refinement of the intervention, which was then discussed and agreed by all investigators and the Trial Steering Group. RESULTS: The results from the feasibility trial were considered appropriate for moving on to a full trial with 70% of participants finding the programme acceptable. The primary outcomes (weight loss and physical activity) provided an important focus for design input from the target group. The contributions highlighted the need to review programme duration, coach contact time, content and use of behaviour change techniques and communications generally (e.g. science and evidence, non-judgemental approaches and avoiding guilt). In addition, the need for emphasis on support rather than education became apparent. The recommendations from peer reviewers focussed on the magnitude of effort required to achieve the intended weight loss and weight loss maintenance. Implementation science supported the use of the capability/opportunity/motivation (COM-B)model in overall design. CONCLUSIONS: The optimisation process has facilitated the development and evaluation of a programme that enables the delivery of a promising intervention to achieve weight management in post-menopausal women. TRIAL REGISTRATION: ISRCTN: ISRCTN11057518. Registered on 21 July 2017. Retrospectively registered.

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial.

BACKGROUND: Eighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? METHODS: The Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallel-group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n = 940) are pregnant smokers (age > 16 years, < 24 weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6 months after birth. The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6 months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case-study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK? DISCUSSION: This phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN15236311. Registered on 9 October 2017.

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.

Feasibility study to assess the delivery of a lifestyle intervention (TreatWELL) for patients with colorectal cancer undergoing potentially curative treatment.

OBJECTIVES: To assess the feasibility of delivering and evaluating a lifestyle programme for patients with colorectal cancer undergoing potentially curative treatments. STUDY DESIGN: Non-randomised feasibility trial. SETTING: National Health Service (NHS) Tayside. PARTICIPANTS: Adults with stage I-III colorectal cancer. INTERVENTION: The programme targeted smoking, alcohol, physical activity, diet and weight management. It was delivered in three face-to-face counselling sessions (plus nine phone calls) by lifestyle coaches over three phases (1: presurgery, 2: surgical recovery and 3: post-treatment recovery). PRIMARY OUTCOME: Feasibility measures (recruitment, retention, programme implementation, achieved measures, fidelity, factors affecting protocol adherence and acceptability). SECONDARY OUTCOMES: Measured changes in body weight, waist circumference, walking and self-reported physical activity, diet, smoking, alcohol intake, fatigue, bowel function and quality of life. RESULTS: Of 84 patients diagnosed, 22 (26%) were recruited and 15 (18%) completed the study. Median time for intervention delivery was 5.5 hours. Coaches reported covering most (>70%) of the intervention components but had difficulties during phase 2. Evaluation measures (except walk test) were achieved by all participants at baseline, and most (<90%) at end of phase 2 and phase 3, but <20% at end of phase 1. Protocol challenges included limited time between diagnosis and surgery and the presence of comorbidities. The intervention was rated highly by participants but limited support from NHS staff was noted. The majority of participants (77%) had a body mass index>25 kg/m2 and none was underweight. Physical activity data showed a positive trend towards increased activity overall, but no other changes in secondary outcomes were detected. CONCLUSIONS: To make this intervention feasible for testing as a full trial, further research is required on (a) recruitment optimisation, (b) appropriate assessment tools, (c) protocols for phase 2 and 3, which can build in flexibility and (d) ways for NHS staff to facilitate the programme. TRIAL REGISTRATION NUMBER: ISRCTN52345929; Post-results.

Barriers and facilitators to smoking cessation in pregnancy and in the post-partum period: The health care professionals' perspective.

OBJECTIVES: Health care professionals and the health care environment play a central role in protecting pregnant and post-partum women and their infants from smoking-related harms. This study aimed to better understand the health professional's perspective on how interactions between women, health care professionals, and the environment influence how smoking is managed. DESIGN: Semi-structured interviews and focus groups. METHODS: Data were from 48 health care staff involved in antenatal or post-partum care at two UK sites, including midwives, obstetricians, health visitors, GPs, pharmacists, service commissioners, and Stop Smoking Service (SSS) advisors and managers. Thematic analysis was guided by a social-ecological framework (SEF). RESULTS: Themes were divided across three SEF levels and represented factors connected to the management of smoking in the health care context and the beliefs and behaviour of pregnant or post-partum smokers. Organizational level: Service reconfigurations, 'last resort' nicotine replacement therapy prescribing policies, and non-mandatory training were largely negative factors. There were mixed views on opt-out referral pathways and positive views on carbon monoxide monitoring. Interpersonal level: Protection of client-professional relationships often inhibited frank discussions about smoking, and weak interservice relationships affected SSS referral motivation and quality. Individual level: Professionals felt community midwives had primary responsibility for managing smoking, although midwives felt underskilled doing this. Midwives' perceived priority for addressing smoking was influenced by the demands from unrelated organizational initiatives. CONCLUSIONS: Opportunities to improve clinical support for pregnant smokers exist at organizational, interservice, and health care professional levels. Interactions between levels reflect the importance of simultaneously addressing different level-specific barriers to smoking cessation in pregnancy. Statement of contribution What is already known on this subject? Few health care professionals discuss smoking cessation support with pregnant or post-partum women. Identified health care professional-related barriers to supporting pregnant and post-partum women to stop smoking include deficits in knowledge and confidence, perceived lack of time, and concerns about damaging client relationships. There is currently a gap in understanding regarding the barriers and facilitators to supporting this group and how interactions between the health care environment and health care professionals influence the way smoking is addressed. What does this study add? This study identifies modifiable factors that can influence cessation support delivery to pregnant and post-partum women. These factors are mapped across organizational, interpersonal, and individual health care professional levels. Service structure, communication pathways, and policies appear to influence what cessation support is offered. Interpersonal and individual factors influence how this support is delivered.

The Power of Product Innovation: Smokers' Perceptions of Capsule Cigarettes.

Introduction: Since being brought to market in 2007, cigarettes with capsules in the filter that can be burst to change the flavor have had remarkable global success, highlighting the importance of product innovation for tobacco companies. Very few studies have explored how these products are perceived by smokers however. This paper sought to address this gap by exploring smokers' awareness of cigarettes with one or two flavor-changing capsules in the filter and the appeal of these products. Methods: Twenty focus groups were conducted in Glasgow and Edinburgh in 2015 with current smokers (N = 120), segmented by age (16-17, 18-24, 25-35, 36-50, >50), gender, and social grade. Results: Awareness, use and appeal of capsule cigarettes was greater among younger adults (16-35 years), who showed most interest in these products. Those who perceived capsules positively mentioned multiple benefits: the ability to burst the capsule, convenience of being able to share cigarettes among menthol and nonmenthol smokers, better taste, fresher breath, reduced smell, and greater discretion. It was suggested that capsule cigarettes, particularly the double capsule cigarette (which had two differently flavored capsules in the filter), would encourage nonsmokers to experiment with smoking and discourage smokers from quitting. Conclusions: The findings offer some reasons behind the global growth of the capsule cigarette segment. Implications: Cigarettes with flavor-changing capsules in the filter have been one of the most successful product innovations of the last decade for tobacco companies. They have received very little academic attention however. Employing focus groups with 120 smokers aged 16 and over, we found that capsule cigarettes held most appeal to, and were considered to be targeted at, younger people, with it suggested that these products would encourage initiation and discourage cessation. This study provides some understanding of how these products are viewed by smokers.

Barriers to and facilitators of smoking cessation in pregnancy and following childbirth: literature review and qualitative study.

BACKGROUND: Although many women stop smoking in pregnancy, others continue, causing harm to maternal and child health. Smoking behaviour is influenced by many factors, including the role of women's significant others (SOs) and support from health-care professionals (HPs). OBJECTIVES: To enhance understanding of the barriers to, and facilitators of, smoking cessation and the feasibility and acceptability of interventions to reach and support pregnant women to stop smoking. DESIGN: Four parts: (1) a description of interventions in the UK for smoking cessation in pregnancy; (2) three systematic reviews (syntheses) of qualitative research of women's, SOs' and HPs' views of smoking in pregnancy using meta-ethnography (interpretative approach for combining findings); (3) semistructured interviews with pregnant women, SOs and HPs, guided by the social-ecological framework (conceptualises behaviour as an outcome of individuals' interactions with environment); and (4) identification of new/improved interventions for future testing. SETTING: Studies in reviews conducted in high-income countries. Qualitative research was conducted from October 2013 to December 2014 in two mixed urban/rural study sites: area A (Scotland) and area B (England). PARTICIPANTS: Thirty-eight studies (1100 pregnant women) in 42 papers, nine studies (150 partners) in 14 papers and eight studies described in nine papers (190 HPs) included in reviews. Forty-one interviews with pregnant women, 32 interviews with pregnant women's SOs and 28 individual/group interviews with 48 HPs were conducted. MAIN OUTCOME MEASURES: The perceived barriers to, and facilitators of, smoking cessation in pregnancy and the identification of potential new/modified interventions. RESULTS: Syntheses identified smoking-related perceptions and experiences for pregnant women and SOs that were fluid and context dependent with the capacity to help or hinder smoking cessation. Themes were analysed in accordance with the social-ecological framework levels. From the analysis of the interviews, the themes that were central to cessation in pregnancy at an individual level, and that reflected the findings from the reviews, were perception of risk to baby, self-efficacy, influence of close relationships and smoking as a way of coping with stress. Overall, pregnant smokers were faced with more barriers than facilitators. At an interpersonal level, partners' emotional and practical support, willingness to change smoking behaviour and role of smoking within relationships were important. Across the review and interviews of HPs, education to enhance knowledge and confidence in delivering information about smoking in pregnancy and the centrality of the client relationship, protection of which could be a factor in downplaying risks, were important. HPs acknowledged that they could best assist by providing support and understanding, and access to effective interventions, including an opt-out referral pathway to Stop Smoking Services, routine carbon monoxide screening, behavioural support and access to pharmacotherapy. Additional themes at community, organisational and societal levels were also identified. LIMITATIONS: Limitations include a design grounded in qualitative studies, difficulties recruiting SOs, and local service configurations and recruitment processes that potentially skewed the sample. CONCLUSIONS: Perceptions and experiences of barriers to and facilitators of smoking cessation in pregnancy are fluid and context dependent. Effective interventions for smoking cessation in pregnancy should take account of the interplay between the individual, interpersonal and environmental aspects of women's lives. FUTURE WORK: Research focus: removing barriers to support, improving HPs' capacity to offer accurate advice, and exploration of weight concerns and relapse prevention. Interventions focus: financial incentives, self-help and social network interventions. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013004170. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Why are some people more successful at lifestyle change than others? Factors associated with successful weight loss in the BeWEL randomised controlled trial of adults at risk of colorectal cancer.

BACKGROUND: The BeWEL (BodyWEight and physicaL activity) randomised controlled trial demonstrated that a weight management programme offered in the colorectal cancer screening setting was effective. However, the differential responses of participants to the programme were notable. This study aimed to explore the factors associated with success and to identify implications for future programme design. METHODS: Analyses were conducted of quantitative data (n = 148) from the BeWEL intervention group to compare demographic and psychosocial characteristics and lifestyle changes in those who met and exceeded the target 7% weight loss ('super-achievers') with those who achieved only 'moderate' or 'low' amounts of weight loss (2-7% loss, or <2% loss, respectively). In-depth qualitative interviews (n = 24) explored in detail the motivations, actions, pathways to weight loss and circumstances of study participants. RESULTS: Over the 12 month intervention period, mean percentage weight loss of super-achievers (n = 33) was 11.5%, compared with moderate-achievers (n = 58) who lost 4.2%, and low-achievers (n = 57) who gained 0.8%. Compared to other groups, super- achievers increased their fruit and vegetable intake (p < 0.01) and physical activity (step count, p < 0.01). 'Super-achievers' did not differ in baseline demographic characteristics from other participants. However, significantly fewer reported that their activities were limited by physical and emotional health and they were more likely to perceive their current diet as harmful. Qualitative analyses found no consistent patterns among super-achievers in relation to some factors identified as important in previous studies, such as social support. However, super-achievers shared several characteristics such as determination and consistency in their engagement with the intervention, receptivity to new information and prompts, previous positive experience of changing health behaviours, being motivated by early success, making changes routine, and an ability to devise and apply strategies for dealing with setback and 'relapse' triggers. CONCLUSIONS: Successful lifestyle change depends on active engagement as well as effective intervention ingredients. Weight loss interventions are likely to be more effective where they can adapt to participants' differing characteristics and needs, while also providing core elements likely to build success.

Financial incentives for smoking cessation in pregnancy: randomised controlled trial.

OBJECTIVE: To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit. DESIGN: Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. SETTING: One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. PARTICIPANTS: 612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking, at least 16 years of age, less than 24 weeks pregnant, and had an exhaled carbon monoxide breath test result of 7 ppm or more. 306 women were randomised to incentives and 306 to control. INTERVENTIONS: The control group received routine care, which was the offer of a face to face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services, and four, weekly support phone calls. The intervention group received routine care plus the offer of up to £400 of shopping vouchers: £50 for attending a face to face appointment and setting a quit date; then another £50 if at four weeks' post-quit date exhaled carbon monoxide confirmed quitting; a further £100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks; a final £200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks' gestation. MAIN OUTCOME MEASURE: The primary outcome was cotinine verified cessation at 34-38 weeks' gestation through saliva (<14.2 ng/mL) or urine (<44.7 ng/mL). Secondary outcomes included birth weight, engagement, and self reported quit at four weeks. RESULTS: Recruitment was extended from 12 to 15 months to achieve the target sample size. Follow-up continued until September 2013. Of the 306 women randomised, three controls opted out soon after enrolment; these women did not want their data to be used, leaving 306 intervention and 303 control group participants in the intention to treat analysis. No harms of financial incentives were documented. Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) P<0.001. The absolute risk difference was 14.0% (95% confidence interval 8.2% to 19.7%). The number needed to treat (where financial incentives need to be offered to achieve one extra quitter in late pregnancy) was 7.2 (95% confidence interval 5.1 to 12.2). The mean birth weight was 3140 g (SD 600 g) in the incentives group and 3120 (SD 590) g in the control group (P=0.67). CONCLUSION: This phase II randomised controlled trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy; as this was only a single centre trial, incentives should now be tested in different types of pregnancy cessation services and in different parts of the United Kingdom. TRIAL REGISTRATION: Current Controlled Trials ISRCTN87508788.

A qualitative study of how young Scottish smokers living in disadvantaged communities get their cigarettes.

INTRODUCTION: Reducing access to cigarettes is an important element of youth smoking prevention strategies. This is particularly so in disadvantaged communities that have high rates of youth smoking. In 2010, Scotland banned proxy sales of tobacco products to under 18-year-olds who were getting older people to purchase cigarettes on their behalf. METHODS: A qualitative study using 24 small single-sex friendship groups. Eighty young people, mostly aged 14-16, of whom 57 were smokers, were recruited in 2012 from community youth groups in 3 socially disadvantaged areas of Scotland. RESULTS: Participants' main sources of cigarettes were proxy sales, family, and peers and friends. Younger smokers were more likely to purchase single cigarettes from older smokers at school and to steal cigarettes from family members. Older and regular smokers were more likely to obtain cigarettes through proxy purchases. Proxy purchases were often facilitated by problem drug users who were willing to buy cigarettes for a small monetary reward. Direct purchases in shops were less commonly reported but appeared to involve complicit action by some retailers. Few reported that they bought blackmarket cigarettes, although they were available in these communities. CONCLUSIONS: Young people in areas of deprivation are still able to circumvent the age-of-sale legislation on selling cigarettes. Even though proxy sales have been banned, they are an important source of cigarettes for disadvantaged young smokers.

Barriers and facilitators to a criminal justice tobacco control coordinator: an innovative approach to supporting smoking cessation among offenders.

AIMS: To examine the barriers and facilitators to effective operation of a regional tobacco control coordinator working within and across criminal justice and public health, whose goal was to raise tobacco control awareness and support the development of smoking cessation treatment for offenders. DESIGN: A reflexive, mixed-methods case study approach using in-depth interviews, project reports and observation of advisory board meetings. SETTING: The coordinator worked with prisons, probation and police custody, where there are high levels of social disadvantage and smoking. PARTICIPANTS: Interviews (n = 34) at different stages of project with the coordinator, project advisers and local stakeholders from criminal justice and public health. MEASUREMENTS: Analysis of facilitators and barriers and the coordinator role from different perspectives. FINDINGS: Readiness to develop cessation services was a critical predictor of different criminal justice settings' engagement with the coordinator role. The coordinator enhanced cessation service delivery in individual prisons where there was a requirement and infrastructure in place to provide such services. In police custody, where there was no central guidance or pre-existing requirements, efforts to establish smoking cessation on the local agenda proved ineffective. In probation settings, the coordinator documented examples of good practice and supported brief intervention training. Variability in willingness to engage limited the project's ability to create joined-up working across criminal justice settings. CONCLUSIONS: In the English criminal justice system, the prison service appears to provide a favourable context for development of smoking cessation support and a means of accessing hard-to-reach groups. Other criminal justice settings, most specifically police custody, appear less responsive to such activity. A coordinator role can improve smoking cessation support in the prison setting, and develop local improvements in tobacco control interventions in other settings such as probation, but as configured here, does not have the capacity to effect change across the criminal justice system.