Digitalising Specialist Smoking Cessation Support in Pregnancy: Views of Pregnant Smokers.

INTRODUCTION: Unsupported attempts to quit smoking during pregnancy have a low success rate. Chances of quitting successfully are higher with an interpersonal treatment programme but there is low uptake of this in the United Kingdom (UK). Delivering a pregnancy-specific treatment programme digitally may provide an alternative treatment route. This study explored pregnant smokers' perceptions of barriers and facilitators to using digital cessation support, along with identifying modes of delivery and engagement enhancers. METHODS: Semi-structured interviews were carried out with an ethnically and socioeconomically diverse sample of 25 participants with recent experience of attempting to quit smoking in pregnancy, aged 20 - 40, from the UK. An inductive thematic analysis approach was used. RESULTS: Digital smoking cessation support, particularly a smartphone app, for pregnancy was felt to overcome many barriers to engaging with interpersonal support, being viewed as more convenient and non-judgemental, providing better consistency of advice, and enhancing privacy and autonomy. However, some participants felt that removing access to a human could undermine a digital support package and reduce engagement. Popular engagement enhancers included self-monitoring (e.g. digital recording of smoking; smartphone-linked carbon monoxide monitoring), online communities, and remote access to nicotine substitution options. Digital support was viewed as having potential as a stand-alone intervention or working in conjunction with standard interpersonal treatment. CONCLUSIONS: The findings support the investigation of a digital support package as both a stand-alone and adjunct to standard interpersonal cessation support in pregnancy to increase the proportion of pregnant smokers who make a supported quit attempt. IMPLICATIONS: In many countries like the UK, there are few smoking cessation options routinely available that provide effective support for smoking cessation in pregnancy. To maximise impact, health services need an effective range of strategies to engage with and support quit attempts made by all pregnant smokers, particularly as interpersonal support options are not often well engaged with. Development of a pregnancy-specific digital support package for smoking cessation in pregnancy may represent a means to help address this gap.

Perspectives of smokers, smokeless tobacco users and cessation practitioners in India: A qualitative study.

INTRODUCTION: India is the second largest consumer of tobacco in the world and accounts for 70% of global deaths due to smokeless tobacco (SLT) use. AIM: The aim of this study is to understand the perspectives of tobacco users (smokers and SLT users) and practitioners in India to inform cessation interventions. METHOD: Semi-structured in-depth interviews with tobacco users (smoked and smokeless; n=23), and healthcare practitioners (n=13). Perspectives were triangulated using thematic analysis to examine convergence, divergence and complementarity of findings. RESULTS: We present the results in a socio-ecological framework to highlight reasons for initiation and continuation of tobacco and motives to quit at the individual, interpersonal, occupational, societal and policy levels. SLT is seen as culturally acceptable compared to smoked forms of tobacco. Emotionally framed messages highlighting negative effects of tobacco on loved ones were perceived to be a better motivator than other types of cessation messages. DISCUSSION: Nuanced differences exist between smokers and SLT user perspectives which have implications for cessation programs. Our findings supplement similar studies with other South Asian populations. IMPLICATIONS FOR PRACTICE: Our study provides useful insights to tailor cessation interventions to the type of tobacco consumed in order to enhance their acceptability and effectiveness.

Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy.

INTRODUCTION: Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation. METHODS AND ANALYSIS: A two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called 'Baby, Me and NRT' (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness. ETHICS AND DISSEMINATION: Ethics approval was granted by Bloomsbury National Health Service's Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants. TRIAL REGISTRATION NUMBER: ISRCTN16830506. PROTOCOL VERSION: 5.0, 10 Oct 2023.

A smoking cessation smartphone app that delivers real-time 'context aware' behavioural support: the Quit Sense feasibility RCT.

Background: During a quit attempt, cues from a smoker's environment are a major cause of brief smoking lapses, which increase the risk of relapse. Quit Sense is a theory-guided Just-In-Time Adaptive Intervention smartphone app, providing smokers with the means to learn about their environmental smoking cues and provides 'in the moment' support to help them manage these during a quit attempt. Objective: To undertake a feasibility randomised controlled trial to estimate key parameters to inform a definitive randomised controlled trial of Quit Sense. Design: A parallel, two-arm randomised controlled trial with a qualitative process evaluation and a 'Study Within A Trial' evaluating incentives on attrition. The research team were blind to allocation except for the study statistician, database developers and lead researcher. Participants were not blind to allocation. Setting: Online with recruitment, enrolment, randomisation and data collection (excluding manual telephone follow-up) automated through the study website. Participants: Smokers (323 screened, 297 eligible, 209 enrolled) recruited via online adverts on Google search, Facebook and Instagram. Interventions: Participants were allocated to 'usual care' arm (n = 105; text message referral to the National Health Service SmokeFree website) or 'usual care' plus Quit Sense (n = 104), via a text message invitation to install the Quit Sense app. Main outcome measures: Follow-up at 6 weeks and 6 months post enrolment was undertaken by automated text messages with an online questionnaire link and, for non-responders, by telephone. Definitive trial progression criteria were met if a priori thresholds were included in or lower than the 95% confidence interval of the estimate. Measures included health economic and outcome data completion rates (progression criterion #1 threshold: ≥ 70%), including biochemical validation rates (progression criterion #2 threshold: ≥ 70%), recruitment costs, app installation (progression criterion #3 threshold: ≥ 70%) and engagement rates (progression criterion #4 threshold: ≥ 60%), biochemically verified 6-month abstinence and hypothesised mechanisms of action and participant views of the app (qualitative). Results: Self-reported smoking outcome completion rates were 77% (95% confidence interval 71% to 82%) and health economic data (resource use and quality of life) 70% (95% CI 64% to 77%) at 6 months. Return rate of viable saliva samples for abstinence verification was 39% (95% CI 24% to 54%). The per-participant recruitment cost was £19.20, which included advert (£5.82) and running costs (£13.38). In the Quit Sense arm, 75% (95% CI 67% to 83%; 78/104) installed the app and, of these, 100% set a quit date within the app and 51% engaged with it for more than 1 week. The rate of 6-month biochemically verified sustained abstinence, which we anticipated would be used as a primary outcome in a future study, was 11.5% (12/104) in the Quit Sense arm and 2.9% (3/105) in the usual care arm (estimated effect size: adjusted odds ratio = 4.57, 95% CIs 1.23 to 16.94). There was no evidence of between-arm differences in hypothesised mechanisms of action. Three out of four progression criteria were met. The Study Within A Trial analysis found a £20 versus £10 incentive did not significantly increase follow-up rates though reduced the need for manual follow-up and increased response speed. The process evaluation identified several potential pathways to abstinence for Quit Sense, factors which led to disengagement with the app, and app improvement suggestions. Limitations: Biochemical validation rates were lower than anticipated and imbalanced between arms. COVID-19-related restrictions likely limited opportunities for Quit Sense to provide location tailored support. Conclusions: The trial design and procedures demonstrated feasibility and evidence was generated supporting the efficacy potential of Quit Sense. Future work: Progression to a definitive trial is warranted providing improved biochemical validation rates. Trial registration: This trial is registered as ISRCTN12326962. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17/92/31) and is published in full in Public Health Research; Vol. 12, No. 4. See the NIHR Funding and Awards website for further award information.

Smokers often fail to quit because of urges to smoke triggered by their surroundings (e.g. being around smokers). We developed a smartphone app ('Quit Sense') which learns about an individual's surroundings and locations where they smoke. During a quit attempt, Quit Sense uses in-built sensors to identify when smokers are in those locations and sends 'in the moment' advice to help prevent them from smoking. We ran a feasibility study to help plan for a future large study to see if Quit Sense helps smokers to quit. This feasibility study was designed to tell us how many participants complete study measures; recruitment costs; how many participants install and use Quit Sense; and estimate whether Quit Sense may help smokers to stop and how it might do this. We recruited 209 smokers using online adverts on Google search, Facebook and Instagram, costing £19 per participant. Participants then had an equal chance of receiving a web link to the National Health Service SmokeFree website ('usual care group') or receive that same web link plus a link to the Quit Sense app ('Quit Sense group'). Three-quarters of the Quit Sense group installed the app on their phone and half of these used the app for more than 1 week. We followed up 77% of participants at 6 months to collect study data, though only 39% of quitters returned a saliva sample for abstinence verification. At 6 months, more people in the Quit Sense group had stopped smoking (12%) than the usual care group (3%). It was not clear how the app helped smokers to quit based on study measures, though interviews found that the process of training the app helped people quit through learning about what triggered their smoking behaviour. The findings support undertaking a large study to tell us whether Quit Sense really does help smokers to quit.

Effects of an increased financial incentive on follow-up in an online, automated smoking cessation trial: A randomised controlled Study Within a Trial (SWAT).

INTRODUCTION: Poor retention in clinical trials can impact on statistical power, reliability, validity and generalisability of findings and is a particular challenge in smoking cessation studies. In online trials with automated follow up mechanisms, poor response also increases resource-need for manual follow up. This study compared two financial incentives on response rates at 6 months follow up, in an online, automated smoking cessation feasibility trial of a cessation smartphone app (Quit Sense). METHODS: A study within a trial (SWAT), embedded within a host randomised controlled trial. Host trial participants were randomised 1:1 to receive either a £10 or £20 voucher incentive, for completing the 6-month questionnaire. Stratification for randomisation to the SWAT was by minimisation to ensure an even split of host trial arm participants, and by 6-week response rate. Outcome measures were: questionnaire completion rate, time to completion, number of completers requiring manual follow up and completeness of responses. RESULTS: 204 participants were randomised to the SWAT. The £20 and £10 incentives did not differ in completion rate at 6 months (79% versus 74%; p=0.362) but did reduce the proportion of participants requiring manual follow up (46% versus 62%; p=0.018) and the median completion time (7 days versus 15 days; p=0.008). Measure response completeness rates were higher among £20 incentive participants, though differences were small for the host trial's primary smoking outcome. CONCLUSIONS: Benefits to using relatively modest increases in incentive for online smoking cessation trials include more rapid completion of follow up questionnaires and reduced manual follow up. IMPLICATIONS: A modest increase in incentive (from £10 to £20) to promote the completion of follow up questionnaires in online smoking cessation trials may not increase overall response rates but could lead to more rapid data collection, a reduced need for manual follow-up and reduced missing data among those who initiate completing a questionnaire. Such an improvement may help to reduce bias, increase validity and generalisability, and improve statistical power in smoking cessation trials.

Text message-based Cessation Intervention for People who Smoked or Used Smokeless Tobacco in India: a Feasibility Randomised Controlled Trial.

INTRODUCTION: Despite the high burden of tobacco use in India, users do not have access to adequate help. This pilot trial aimed to evaluate the feasibility and acceptability of a text messaging intervention for tobacco cessation, generate preliminary estimates of its impact, and fine-tune procedures for a definitive trial. METHODS: Parallel two-arm single blind individually randomised controlled pilot trial with nested qualitative study. Participants included adult current tobacco users (smoked and smokeless). Eligible and consenting participants were randomised to receive either (a) text messaging intervention (ToQuit) which covered specific content areas such as psychoeducation about consequences of tobacco use and benefits of quitting and tobacco avoidance strategies or (b) information about tobacco cessation helplines such as the helpline number and the languages in which tobacco cessation support was available (control). Feasibility data included screening and consent rates, treatment dropouts and outcome ascertainment. The primary abstinence outcome was self-reported abstinence from tobacco in the past seven days at three months post-randomisation. In-depth interviews were conducted with a sub-sample of participants primarily to collect acceptability data. The primary abstinence analysis used a chi-squared test and logistic regression (complete-case), and qualitative data analysed using thematic analysis. RESULTS: Ninety eight participants were randomised into the two trial arms; 77 (79%) completed outcome evaluation. No between-arm differences in abstinence were found though findings favoured the intervention (7-day abstinence: ToQuit 23%, control 19%; adjusted odds ratio 1.23, 95% confidence interval 0.38, 3.97). Participants appreciated the language, comprehensibility, and relevance of the messages; and reported overall satisfaction with and positive impact from the intervention on their lives. CONCLUSION: The findings indicate the acceptability and feasibility of ToQuit and if found effective, it could be a potentially scalable first-line response to tobacco use in low resource settings. IMPLICATIONS: Our pilot RCT provides sufficient findings supporting the acceptability and feasibility of an intervention for tobacco cessation which is suitable for a context which has a shortage of healthcare workers and for individuals who use smoked or smokeless tobacco. This is critical on a background of limited contextually relevant interventions for a problem with a high burden in low- and middle- income countries such as India.

Experts' views on translating NHS support to stop smoking in pregnancy into a comprehensive digital intervention.

Many pregnant smokers need support to quit successfully. In the United Kingdom, trained smoking cessation advisors deliver structured behavioural counselling alongside access to free nicotine replacement therapy (NRT); known as the 'Standard Treatment Programme' (STP). Pregnant smokers who access STP support are more likely to quit, but uptake is low. A digital intervention could be offered as an adjunct or alternative to existing STP support to increase cessation rates. However, there are few pregnancy-specific digital options routinely available and, among those that are, there is limited evidence of their effectiveness. This study investigated experts' views on the feasibility of translating the STP into a comprehensive digital intervention. Virtual group and individual interviews were undertaken with 37 experts (11 focus groups, 3 interviews) with a real-time voting activity in the focus groups to prompt discussion. Framework Analysis was applied to the data to examine themes and patterns. Experts were supportive of a digital translation of the STP and considered most behavioural counselling content to be transferable. However, replicating human-to-human accountability, empathy and the ability to go 'off-script' was thought more challenging. Suggestions for how this might be achieved included tailoring and personalisation, use of artificial intelligence tools, peer support and the option to escalate contact to a human advisor. Experts had mixed views on the role that exhaled breath carbon monoxide monitoring might have in a digital cessation intervention for pregnancy. Electronic provision of free NRT, and potentially e-cigarettes, without interpersonal support was generally well received. However, experts had concerns about it exacerbating low NRT adherence, governance issues (e.g. being accountable for the suitability of recommended products), and people's ability to misrepresent their eligibility. The STP was considered largely transferable to a digital intervention and potentially helpful for cessation in pregnancy, so merits further development and evaluation.

The Effectiveness of Text Support for Stopping Smoking in Pregnancy (MiQuit): Multi-Trial Pooled Analysis Investigating Effect Moderators and Mechanisms of Action.

INTRODUCTION: Digital cessation support appeals to pregnant smokers. In two pooled RCTs, MiQuit, a pregnancy-specific tailored text messaging intervention, did not show effectiveness for validated prolonged abstinence. However, secondary outcomes and potential moderators and mediators have not been investigated. We aimed to determine, using pooled RCT data: (1) MiQuit effectiveness on a range of smoking outcomes; (2) whether baseline tobacco dependence or quit motivation moderate effectiveness; (3) whether hypothesized mechanisms of action (quitting determination, self-efficacy, baby harm beliefs, lapse prevention strategies) mediate effectiveness. METHODS: Pooled data analysis from two procedurally identical RCTs comparing MiQuit (N = 704) to usual care (N = 705). Participants were smokers, <25 weeks pregnant, recruited from 40 English antenatal clinics. Outcomes included self-reported 7-day abstinence at 4 weeks post-baseline and late pregnancy, and prolonged abstinence. Late pregnancy outcomes were also biochemically validated. We used hierarchical regression and structural equation modeling. RESULTS: MiQuit increased self-reported, 7-day abstinence at 4 weeks (OR = 1.73 [95% CI 1.10-2.74]) and was borderline significant at late pregnancy (OR = 1.34 [0.99-1.82]) but not for prolonged or validated outcomes. Effectiveness was not moderated by baseline dependence (heaviness of smoking "low" vs. "moderate-high") or motivation (planning to quit ≤30 days [high] vs. >30 days [low]), but effects on self-reported outcomes were larger for the high motivation sub-group. MiQuit had a small effect on mean lapse prevention strategies (MiQuit 8.6 [SE 0.17], UC 8.1 [SE 0.17]; P = .030) but not other mechanisms. CONCLUSIONS: MiQuit increased short-term but not prolonged or validated abstinence and may be most effective for those motivated to quit sooner. IMPLICATIONS: Digital cessation support appeals to pregnant smokers. MiQuit, a tailored, theory-guided text messaging program for quitting smoking in pregnancy, has not shown effectiveness for validated prolonged abstinence in two previous RCTs but its impact on other smoking outcomes and potential mechanisms of action are unknown. When pooling trial data, MiQuit increased self-reported short-term abstinence, including making a quit attempt and abstinence at 4-week follow-up, but not late pregnancy, sustained, or validated abstinence. MiQuit appeared effective at late pregnancy for participants with high quitting motivation, but its mechanisms of action remain uncertain. Additional support components are likely required to enhance effectiveness.

Safety of e-cigarettes and nicotine patches as stop-smoking aids in pregnancy: Secondary analysis of the Pregnancy Trial of E-cigarettes and Patches (PREP) randomized controlled trial.

AIMS: The aim of this study was to examine the safety of e-cigarettes (EC) and nicotine patches (NRT) when used to help pregnant smokers quit. DESIGN: A recent trial of EC versus NRT reported safety outcomes in the randomized arms. We conducted a further analysis based on product use. SETTING: Twenty-three hospitals in England and a stop-smoking service in Scotland took part. PARTICIPANTS: The participants comprised 1140 pregnant smokers. INTERVENTIONS: We compared women using and not using EC and NRT regularly during pregnancy. MEASUREMENTS: Measurements included nicotine intake compared with baseline, birth weight, other pregnancy outcomes, adverse events, maternal respiratory symptoms and relapse in early abstainers. FINDINGS: Use of EC was more common than use of NRT (47.3% vs 21.6%, P < 0.001). Women who stopped smoking (abstainers) and used EC at the end-of-pregnancy (EOP) reduced their salivary cotinine by 45% [49.3 ng/ml, 95% confidence interval (CI) = -79.8 to -10]. Only one abstainer used NRT at EOP. In dual users, cotinine increased by 19% (24 ng/ml, 95% CI = 3.5-68). In women reporting a reduction of at least 50% in cigarette consumption, cotinine levels increased by 10% in those using nicotine products and by 9% in those who did not. Birth weights in dual users and exclusive smokers were the same (3.1 kg). Birth weight in abstainers using either nicotine product was higher than in smokers [3.3 kg, standard deviation (SD) = 0.7] versus 3.1 kg, SD = 0.6; difference = 0.15 kg, 95% CI = 0.05-0.25) and not different from abstainers not using nicotine products (3.1 kg, SD = 0.8). Abstainers and smokers using nicotine products had no worse pregnancy outcomes or more adverse events than abstainers and smokers not using them. EC users reported more improvements than non-users in cough [adjusted relative risk (aRR) = 0.59, 95% CI = 0.37-0.93] and phlegm (aRR = 0.53, 95% CI = 0.31-0.92), controlling for smoking status. EC or NRT use had no association with relapse. CONCLUSIONS: Regular use of e-cigarettes or nicotine patches by pregnant smokers does not appear to be associated with any adverse outcomes.

Evaluation of Feasibility and Acceptability of a Text-Messaging Intervention for Tobacco Cessation in India.

INTRODUCTION: The aim of our study was to assess the feasibility and acceptability of a brief behavioral intervention for tobacco cessation delivered via mobile phone text messaging in India. AIMS AND METHODS: We conducted an uncontrolled intervention cohort study in adult current users of tobacco. The participants received intervention messages on their mobile phones for eight weeks. We collected qualitative data about participants' perceptions of intervention delivery and receipt, acceptability, and feasibility of the intervention. The outcomes measured at 3 months post-recruitment were self-reported 7- and 28-day point-prevalence abstinence, and Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) risk categories for tobacco-low (0-3), moderate (4-26), and high (≥27). RESULTS: We recruited 26 eligible participants, and 22 completed the outcome assessments. The participants generally perceived the intervention content to be simple to access and useful in facilitating a change in tobacco use. None of the participants indicated that they wanted to discontinue receiving the intervention messages. Some suggestions for enhancing acceptability included supplementing text messaging with more intensive counseling and the use of multimedia content. Eighteen percent of participants reported abstinence in the past 7 and 28 days. A greater proportion of those who used smokeless tobacco were abstinent at follow-up compared to those who smoked (42.9% vs. 6.7%; p = .04). CONCLUSIONS: If effective, simple and low-cost mobile phone text messaging can be used to deliver interventions for tobacco use, and has the potential to be scaled up so it can be delivered to populations of smokers interested in receiving cessation support. IMPLICATIONS: Our study is an important step towards the development of a contextually relevant intervention suited for low- and middle-income countries and which is responsive to the needs of both those who use smoked and smokeless tobacco. If found to be effective, our intervention would be a scalable solution to overcome the human resource related barrier to accessing tobacco cessation services in low resource settings.

The Relationship Between Reported Daily Nicotine Dose from NRT and Daily Cigarette Consumption in Pregnant Women Who Smoke in an Observational Cohort Study.

INTRODUCTION: For nonpregnant people unable to quit smoking, the NHS recommends nicotine replacement therapy (NRT) for smoking reduction. This is not recommended during pregnancy due to concerns about higher nicotine intake than smoking alone. We investigated the relationship between daily nicotine dose from NRT and cigarette consumption reported by pregnant women receiving smoking cessation support. METHODS: We conducted secondary analysis of data from currently smoking pregnant women, recruited from antenatal clinics (Nottingham University Hospitals, UK) or online between June 2019-September 2020. Participants set a quit date, received a prototype NRT adherence intervention, and reported cigarettes per day (CPD) and daily NRT dose (mg) via smartphone app for 28 days. RESULTS: 388 women were screened, 32 (8%) were eligible and joined the study. 24 (75%) submitted 510 app reports in total. 17 (71%) reported smoking and using NRT concurrently on at least one day, with concurrent use reported on 109 (21%) of app reports.The relationship between daily NRT dose and CPD followed an exponential decay curve of approximately 7%. In multilevel repeated measures modelling using 4 linear splines (knots 17, 40, and 85 mg/NRT), significant fixed effects of daily NRT dose on CPD were observed for splines 1, 3, and 4. The strongest association was spline 1 (0-17 mg/NRT), where each 10 mg NRT increase was associated with a 0.6 CPD reduction (24% on average). CONCLUSIONS: Among women in a cessation study, many smoked and used NRT concurrently; within these women, daily nicotine dose and heaviness of smoking were inversely related. IMPLICATIONS: Findings have implications for the design of future interventions intended to reduce harm associated with smoking in pregnancy. They suggest using NRT alongside smoking in pregnancy could help some women reduce the number of cigarettes they smoke per day.

Helping pregnant smokers quit: a multi-centre randomised controlled trial of electronic cigarettes versus nicotine replacement therapy.

Background: Some pregnant smokers try e-cigarettes, but effectiveness and safety of such use are unknown. Objectives: To compare effectiveness and safety of nicotine patches and e-cigarettes in pregnancy. Design: A pragmatic multi-centre randomised controlled trial. Setting: Twenty-three hospitals across England, and a Stop Smoking Service in Scotland. Participants: One thousand one hundred and forty pregnant daily smokers (12-24 weeks' gestation) motivated to stop smoking, with no strong preference for using nicotine patches or e-cigarettes. Interventions: Participants in the e-cigarette arm were posted a refillable e-cigarette device with two 10 ml bottles of tobacco-flavoured e-liquid (18 mg nicotine). Participants in the nicotine patches arm were posted a 2-week supply of 15 mg/16-hour nicotine patches. Supplies were provided for up to 8 weeks. Participants sourced further supplies themselves as needed. Participants in both arms received support calls prior to their target quit date, on the quit date, and weekly for the next 4 weeks. Outcome measures: The primary outcome was validated prolonged abstinence at the end of pregnancy. Participants lost to follow-up or not providing biochemical validation were included as non-abstainers. Secondary outcomes included self-reported abstinence at different time points, treatment adherence and safety outcomes. Results: Only 55% of self-reported abstainers mailed back useable saliva samples. Due to this, validated sustained abstinence rates were low (6.8% vs. 4.4% in the e-cigarettes and nicotine patches arms, respectively, risk ratio = 1.55, 95% confidence interval 0.95 to 2.53; Bayes factor = 2.7). In a pre-specified sensitivity analysis that excluded abstainers using non-allocated products, the difference became significant (6.8% vs. 3.6%, risk ratio = 1.93, 95% confidence interval 1.14 to 3.26; Bayes factor = 10). Almost a third of the sample did not set a target quit date and the uptake of support calls was low, as was the initial product use. At end of pregnancy, 33.8% versus 5.6% of participants were using their allocated product in the e-cigarettes versus nicotine patches arm (risk ratio = 6.01, 95% confidence interval 4.21 to 8.58). Regular use of e-cigarettes in the nicotine patches arm was more common than use of nicotine replacement products in the e-cigarette arm (17.8% vs. 2.8%). Rates of adverse events and adverse birth outcomes were similar in the two study arms, apart from participants in the e-cigarette arm having fewer infants with low birthweight (<2500 g) (9.6% vs. 14.8%, risk ratio = 0.65, 95% confidence interval 0.47 to 0.90; Bayes factor = 10.3). Limitations: Low rates of validation reduced the study power. A substantial proportion of participants did not use the support on offer sufficiently to test its benefits. Sample size may have been too small to detect differences in less frequent adverse effects. Conclusions: E-cigarettes were not significantly more effective than nicotine patches in the primary analysis, but when e-cigarettes use in the nicotine patches arm was accounted for, e-cigarettes were almost twice as effective as patches in all abstinence outcomes. In pregnant smokers seeking help, compared to nicotine patches, e-cigarettes are probably more effective, do not pose more risks to birth outcomes assessed in this study and may reduce the incidence of low birthweight. Future work: Routine monitoring of smoking cessation and birth outcomes in pregnant women using nicotine patches and e-cigarettes and further studies are needed to confirm these results. Trial registration: This trial is registered as ISRCTN62025374 and Eudract 2017-001237-65. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 13. See the NIHR Journals Library website for further project information.

Like many other smokers in the UK, some pregnant smokers try to limit or stop smoking with the help of e-cigarettes. It is not known whether this helps with stopping smoking and whether using e-cigarettes has any bad effects on the baby. We recruited 1140 pregnant smokers who wanted to quit. A random half were given nicotine patches, which are commonly used to help smokers quit. The other half were given an e-cigarette. They also received six weekly phone calls to support them in stopping smoking. We then looked at how many in each group stopped smoking by the end of pregnancy. More women stopped smoking in the group that was given an e-cigarette, but the difference was small and could be due to chance. However, some of the women in the nicotine patch group who had successfully stopped smoking were using e-cigarettes rather than patches. When these (and women in the e-cigarette group who used patches) were not counted, e-cigarettes helped almost twice as many women stop smoking than patches. E-cigarettes were better than patches in preventing low birthweight (having babies who weigh less than 2.5 kg). Otherwise, women given patches and those given e-cigarettes (and their babies) had similar numbers of medical complications. For pregnant women who smoke and need help to quit, e-cigarettes are probably more helpful than nicotine patches, and do not pose any additional risks to women or their babies.

Mobile Phone Text Messages to Support People to Stop Smoking by Switching to Vaping: Codevelopment, Coproduction, and Initial Testing Study.

BACKGROUND: SMS text messages are affordable, scalable, and effective smoking cessation interventions. However, there is little research on SMS text message interventions specifically designed to support people who smoke to quit by switching to vaping. OBJECTIVE: Over 3 phases, with vapers and smokers, we codeveloped and coproduced a mobile phone SMS text message program. The coproduction paradigm allowed us to collaborate with researchers and the community to develop a more relevant, acceptable, and equitable SMS text message program. METHODS: In phase 1, we engaged people who vape via Twitter and received 167 responses to our request to write SMS text messages for people who wish to quit smoking by switching to vaping. We screened, adjusted, refined, and themed the messages, resulting in a set of 95 that were mapped against the Capability, Opportunity, and Motivation-Behavior constructs. In phase 2, we evaluated the 95 messages from phase 1 via a web survey where participants (66/202, 32.7% woman) rated up to 20 messages on 7-point Likert scales on 9 constructs: being understandable, clear, believable, helpful, interesting, inoffensive, positive, and enthusiastic and how happy they would be to receive the messages. In phase 3, we implemented the final set of SMS text messages as part of a larger randomized optimization trial, in which 603 participants (mean age 38.33, SD 12.88 years; n=369, 61.2% woman) received SMS text message support and then rated their usefulness and frequency and provided free-text comments at the 12-week follow-up. RESULTS: For phase 2, means and SDs were calculated for each message across the 9 constructs. Those with means below the neutral anchor of 4 or with unfavorable comments were discussed with vapers and further refined or removed. This resulted in a final set of 78 that were mapped against early, mid-, or late stages of quitting to create an order for the messages. For phase 3, a total of 38.5% (232/603) of the participants provided ratings at the 12-week follow-up. In total, 69.8% (162/232) reported that the SMS text messages had been useful, and a significant association between quit rates and usefulness ratings was found (χ21=9.6; P=.002). A content analysis of free-text comments revealed that the 2 most common positive themes were helpful (13/47, 28%) and encouraging (6/47, 13%) and the 2 most common negative themes were too frequent (9/47, 19%) and annoying (4/47, 9%). CONCLUSIONS: In this paper, we describe the initial coproduction and codevelopment of a set of SMS text messages to help smokers stop smoking by transitioning to vaping. We encourage researchers to use, further develop, and evaluate the set of SMS text messages and adapt it to target populations and relevant contexts.

BabyBreathe trial: protocol for a randomised controlled trial of a complex intervention to prevent postpartum return to smoking.

INTRODUCTION: Many people quit smoking during pregnancy, but postpartum smoking relapse is common. Maintaining smoking abstinence achieved during pregnancy is key to improving maternal and child health. There are no evidence-based interventions for preventing postpartum smoking relapse. This trial aims to determine whether an intervention to prevent postpartum relapse is effective and cost-effective. METHODS AND ANALYSIS: A randomised controlled trial of a complex intervention to prevent postpartum smoking relapse (BabyBreathe), with internal pilot, economic and process evaluations. Participants are adults who are pregnant and who report having quit smoking in the 12 months before, or during pregnancy. Participants are eligible if they read and understand English, and provide informed consent. Following consent and biochemical validation of smoking abstinence, participants are randomised to intervention or usual care/control (no specific relapse prevention support). The BabyBreathe intervention consists of manualised advice from a trained member of the health visiting service, health information leaflets for participants and partners, access to the BabyBreathe website and app. At the time of birth, participants are posted the BabyBreathe box and support is provided by text message for up to 12 months postpartum. Target sample size is 880, recruiting across midwifery services at four hubs in England and Scotland and through remote advertising in England, Scotland, Wales and Northern Ireland. Outcomes are collected at 6 and 12 months. The primary outcome is self-reported sustained smoking abstinence at 12 months, carbon monoxide verified. Secondary outcomes include self-reported abstinence, time to relapse, partner smoking status and quality of life. ETHICS AND DISSEMINATION: The trial was approved by the North West Preston Research Ethics committee (21/NW/0017). Dissemination will include publication in peer-reviewed journals, presentation at academic and public conferences including patient and public involvement and to policymakers and practitioners. TRIAL REGISTRATION NUMBER: ISRCTN70307341.

E-cigarette support for smoking cessation: Identifying the effectiveness of intervention components in an on-line randomized optimization experiment.

AIMS, DESIGN AND SETTING: The aim of this study was to determine which combination(s) of five e-cigarette-orientated intervention components, delivered on-line, affect smoking cessation. An on-line (UK) balanced five-factor (2 × 2 × 2 × 2 × 2 = 32 intervention combinations) randomized factorial design guided by the multi-phase optimization strategy (MOST) was used. PARTICIPANTS: A total of 1214 eligible participants (61% female; 97% white) were recruited via social media. INTERVENTIONS: The five on-line intervention components designed to help smokers switch to exclusive e-cigarette use were: (1) tailored device selection advice; (2) tailored e-liquid nicotine strength advice; (3): tailored e-liquid flavour advice; (4) brief information on relative harms; and (5) text message (SMS) support. MEASUREMENTS: The primary outcome was 4-week self-reported complete abstinence at 12 weeks post-randomization. Primary analyses were intention-to-treat (loss to follow-up recorded as smoking). Logistic regressions modelled the three- and two-way interactions and main effects, explored in that order. FINDINGS: In the adjusted model the only significant interaction was a two-way interaction, advice on flavour combined with text message support, which increased the odds of abstinence (odds ratio = 1.55, 95% confidence interval = 1.13-2.14, P = 0.007, Bayes factor = 7.25). There were no main effects of the intervention components. CONCLUSIONS: Text-message support with tailored advice on flavour is a promising intervention combination for smokers using an e-cigarette in a quit attempt.

Using Smartphone Survey and GPS Data to Inform Smoking Cessation Intervention Delivery: Case Study.

BACKGROUND: Interest in quitting smoking is common among young adults who smoke, but it can prove challenging. Although evidence-based smoking cessation interventions exist and are effective, a lack of access to these interventions specifically designed for young adults remains a major barrier for this population to successfully quit smoking. Therefore, researchers have begun to develop modern, smartphone-based interventions to deliver smoking cessation messages at the appropriate place and time for an individual. A promising approach is the delivery of interventions using geofences-spatial buffers around high-risk locations for smoking that trigger intervention messages when an individual's phone enters the perimeter. Despite growth in personalized and ubiquitous smoking cessation interventions, few studies have incorporated spatial methods to optimize intervention delivery using place and time information. OBJECTIVE: This study demonstrates an exploratory method of generating person-specific geofences around high-risk areas for smoking by presenting 4 case studies using a combination of self-reported smartphone-based surveys and passively tracked location data. The study also examines which geofence construction method could inform a subsequent study design that will automate the process of deploying coping messages when young adults enter geofence boundaries. METHODS: Data came from an ecological momentary assessment study with young adult smokers conducted from 2016 to 2017 in the San Francisco Bay area. Participants reported smoking and nonsmoking events through a smartphone app for 30 days, and GPS data was recorded by the app. We sampled 4 cases along ecological momentary assessment compliance quartiles and constructed person-specific geofences around locations with self-reported smoking events for each 3-hour time interval using zones with normalized mean kernel density estimates exceeding 0.7. We assessed the percentage of smoking events captured within geofences constructed for 3 types of zones (census blocks, 500 ft2 fishnet grids, and 1000 ft2 fishnet grids). Descriptive comparisons were made across the 4 cases to better understand the strengths and limitations of each geofence construction method. RESULTS: The number of reported past 30-day smoking events ranged from 12 to 177 for the 4 cases. Each 3-hour geofence for 3 of the 4 cases captured over 50% of smoking events. The 1000 ft2 fishnet grid captured the highest percentage of smoking events compared to census blocks across the 4 cases. Across 3-hour periods except for 3:00 AM-5:59 AM for 1 case, geofences contained an average of 36.4%-100% of smoking events. Findings showed that fishnet grid geofences may capture more smoking events compared to census blocks. CONCLUSIONS: Our findings suggest that this geofence construction method can identify high-risk smoking situations by time and place and has potential for generating individually tailored geofences for smoking cessation intervention delivery. In a subsequent smartphone-based smoking cessation intervention study, we plan to use fishnet grid geofences to inform the delivery of intervention messages.

Development of "Baby, Me, & NRT": A Behavioral Intervention to Improve the Effectiveness of Nicotine Replacement Therapy in Pregnancy.

BACKGROUND: The effectiveness of Nicotine Replacement Therapy (NRT) for smoking cessation in pregnancy is limited by inconsistent and incorrect use. This paper describes the development process for "Baby, Me, & NRT", a novel pregnancy-specific intervention aimed at enhancing adherence to NRT. METHODS: An integrated approach to intervention development was used, combining evidence, theory, stakeholders' feedback, and tailoring principles. The process involved six iterative steps: (1) synthesizing relevant published evidence and guidance, (2) collecting primary qualitative data on barriers and facilitators to NRT adherence along with potential intervention design features, (3) identifying relevant behavioral theories and mapping the evidence against these, (4) prioritizing behavioral determinants identified in steps 1 and 2, generating intervention objectives, and identifying behavior change techniques which target the prioritized determinants, (5) consulting with stakeholders on intervention components, key content and tailoring features, and (6) producing a prototype intervention along with implementation guidance. RESULTS: The prototype intervention comprises of a multi-component, 1-month cessation programme, which includes six enhanced behavioral support sessions delivered by a trained advisor, tailored text messages, a website, and an illustrated booklet. It promotes the uptake of high-dose and combination NRT, emphasizes the importance of adherence, addresses motivation to use NRT, proactively helps problem solve NRT use issues, and provides guidance on preventing and managing smoking lapses. CONCLUSION: The development process generated an evidence- and theory-guided intervention, designed with stakeholder input, aimed at improving NRT effectiveness for smoking cessation in pregnancy. The prototype intervention has since been optimized and is being evaluated in a randomized controlled trial.

An Automated, Online Feasibility Randomized Controlled Trial of a Just-In-Time Adaptive Intervention for Smoking Cessation (Quit Sense).

INTRODUCTION: Learned smoking cues from a smoker's environment are a major cause of lapse and relapse. Quit Sense, a theory-guided Just-In-Time Adaptive Intervention smartphone app, aims to help smokers learn about their situational smoking cues and provide in-the-moment support to help manage these when quitting. METHODS: A two-arm feasibility randomized controlled trial (N = 209) to estimate parameters to inform a definitive evaluation. Smoker's willing to make a quit attempt were recruited using online paid-for adverts and randomized to "usual care" (text message referral to NHS SmokeFree website) or "usual care" plus a text message invitation to install Quit Sense. Procedures, excluding manual follow-up for nonresponders, were automated. Follow-up at 6 weeks and 6 months included feasibility, intervention engagement, smoking-related, and economic outcomes. Abstinence was verified using cotinine assessment from posted saliva samples. RESULTS: Self-reported smoking outcome completion rates at 6 months were 77% (95% CI 71%, 82%), viable saliva sample return rate was 39% (95% CI 24%, 54%), and health economic data 70% (95% CI 64%, 77%). Among Quit Sense participants, 75% (95% CI 67%, 83%) installed the app and set a quit date and, of those, 51% engaged for more than one week. The 6-month biochemically verified sustained abstinence rate (anticipated primary outcome for definitive trial), was 11.5% (12/104) among Quit Sense participants and 2.9% (3/105) for usual care (adjusted odds ratio = 4.57, 95% CIs 1.23, 16.94). No evidence of between-group differences in hypothesized mechanisms of action was found. CONCLUSIONS: Evaluation feasibility was demonstrated alongside evidence supporting the effectiveness potential of Quit Sense. IMPLICATIONS: Running a primarily automated trial to initially evaluate Quit Sense was feasible, resulting in modest recruitment costs and researcher time, and high trial engagement. When invited, as part of trial participation, to install a smoking cessation app, most participants are likely to do so, and, for those using Quit Sense, an estimated one-half will engage with it for more than 1 week. Evidence that Quit Sense may increase verified abstinence at 6-month follow-up, relative to usual care, was generated, although low saliva return rates to verify smoking status contributed to considerable imprecision in the effect size estimate.

Development and Content Validation of a Questionnaire for Measuring Beliefs About Using Nicotine Replacement Therapy for Smoking Cessation in Pregnancy.

INTRODUCTION: Improving adherence to nicotine replacement therapy (NRT) in pregnancy may result in higher smoking cessation rates. Informed by the Necessities and Concerns Framework, we developed an intervention targeting pregnancy NRT adherence. To evaluate this, we derived the NRT in pregnancy necessities and concerns questionnaire (NiP-NCQ), which measures perceived need for NRT and concerns about potential consequences. AIMS AND METHODS: Here we describe the development and content validation of NiP-NCQ. From qualitative work, we identified potentially modifiable determinants of pregnancy NRT adherence and classed these as necessity beliefs or concerns. We translated these into draft self-report items and piloted items on 39 pregnant women offered NRT and a prototype NRT adherence intervention, assessing distributions and sensitivity to change. After removing poorly performing items, smoking cessation experts (N = 16) completed an online discriminant content validation (DCV) task to determine whether retained items measure a necessity belief, concern, both, or neither construct. RESULTS: Draft NRT concern items encompassed safety for the baby, side effects, too much or insufficient nicotine, and addictiveness. Draft necessity belief items included perceived need for NRT for short- and longer-term abstinence, and desire to minimize or cope without NRT. Of 22 out of 29 items retained after piloting, four were removed following the DCV task: three were judged to measure neither construct and one possibly both. The final NiP-NCQ comprised nine items per construct (18 total). CONCLUSIONS: The NiP-NCQ measures potentially modifiable determinants of pregnancy NRT adherence within two distinct constructs and may have research and clinical utility for evaluating interventions targeting these. IMPLICATIONS: Poor adherence to NRT in pregnancy may result from low perceived need and concerns about consequences; interventions challenging these beliefs may yield higher smoking cessation rates. To evaluate an NRT adherence intervention informed by the Necessities and Concerns Framework, we developed the NiP-NCQ. Through the content development and refinement processes described in this paper, we derived an evidence-based, 18-item questionnaire measuring two distinct constructs within two nine-item subscales. Higher concerns and lower necessity beliefs indicate more negative NRT beliefs; NiP-NCQ may have research and clinical utility for interventions targeting these.