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BackgroundThe prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. ObjectiveThis definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. MethodsThe iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)—the control—with usual care plus iQuit—the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. ResultsThe primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. ConclusionsiQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. International Registered Report Identifier (IRRID)DERR1-10.2196/17160

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 (

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. [ABSTRACT FROM AUTHOR]

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. Plain language summary: 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. Scientific summary: Background: Three million UK smokers attempt to stop smoking each year, but over 80% relapse. A lapse (any smoking) early on in a quit attempt is strongly associated with subsequent relapse back to smoking. Approximately half of all lapses are due to environmental smoking cues which can elicit cravings to smoke, such as the presence of cigarettes or being in a location which a smoker associates with smoking. Few interventions are effective at targeting cue-induced cravings. Smokers are more likely to prevent lapses if they better understand their smoking cues and use lapse prevention strategies, such as controlled deep breathing or avoiding other smokers, to combat these. This would likely help them avoid or cope with cue-induced cravings, but smokers typically lack skills in applying these effectively. If smokers trying to quit used effective lapse prevention strategies, this would very likely increase their chances of success. With patient and public involvement, we developed, refined and piloted a theory-guided Just-In-Time Adaptive Intervention smartphone app called Quit Sense that provides support to help smokers manage environmental cues to smoke as they arise. Pilot studies have shown that Quit Sense can provide 'in the moment' support to smokers, including lapse prevention strategies, and that users will engage with the app and find it acceptable. As Quit Sense is such a novel intervention, before a 'definitive' randomised controlled trial (RCT) can be conducted to test effectiveness, it is important to first undertake a RCT to establish whether such a study might be feasible. Objectives: The main objective was to conduct a feasibility RCT of Quit Sense to inform a definitive effectiveness trial, by estimating: completion rates for the anticipated primary outcome for a full trial (6-month self-reported abstinence with biochemical validation, based on the Russell standard); usual care arm cessation rate; cost of recruitment using online advertising; rates of app installation, use and acceptability; completion of smoking cessation-related resource use and quality-of-life data; intervention effect on anticipated primary outcome; intervention effect on hypothesised mechanisms of action of app at 6 weeks post enrolment; participant views of the app, as part of a qualitative process evaluation. Design: A parallel, two-arm RCT with an embedded qualitative interview process evaluation was undertaken. The evaluation included a preliminary cost-effectiveness analysis and a nested randomised study [Study Within A Trial (SWAT)] assessing the effects of different financial incentives on 6-month follow-up rates. Setting: The study setting was online and trial procedures were primarily automated. Participants: Participants were recruited via online adverts on Google search, Facebook and Instagram, screened for eligibility on the study website and enrolled if they were regular smokers, aged 16 years and above, were willing to make a quit attempt and owned an Android smartphone. Interventions: After completing the baseline questionnaire participants were then randomly allocated to a 'usual care' arm (text message referral to NHS SmokeFree website) or a 'usual care' plus Quit Sense arm, via a text message invitation to install the Quit Sense app. The Quit Sense app required users to set a quit date and then, leading up to their quit date, alongside other support features, invited them to report their smoking in real time and indicate the presence of key environmental smoking cues using a smoking behaviour logging tool. Once their quit date arrived, the app used location sensing and what it had learnt about the individual's smoking behaviour to tailor the timing and content of support messages when they spent time in self-identified high-risk locations. The support and advice aimed to help smokers learn about their smoking behaviour, prepare for their quit attempt and promoted the use of effective lapse prevention strategies during their quit attempt. Main outcomes measures: All participants were contacted at 6-week and 6-month follow-up. This was done initially by text message with an embedded link to the follow-up questionnaires or, if no response, manually by telephone. As part of a SWAT , participants underwent secondary randomisation to receive either a £10 or £20 incentive for completion of the 6-month questionnaire. Four progression criteria and corresponding thresholds for seeking to undertake a definitive trial were set a priori. Criteria were met if each threshold was included in or lower than the 95% confidence interval (CI) of the estimate. Trial 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%), the app's effect on biochemically verified abstinence at 6 months (anticipated primary outcome of definitive trial) and hypothesised mechanisms of action. The qualitative process evaluation sought to identify participants' views of the trial and the Quit Sense app. The protocol and statistical and health economics analysis plan were pre-specified and published (open access). Results: Of the people screened (N = 323), 299 (93%) were eligible and 209 (65% of screened) were consented and randomised either to the usual care arm (n = 105) or to the Quit Sense arm (n = 104). Completion of self-reported smoking questions was 71% (149/209; 95% CI 65% to 77%) and 77% (160/209; 95% CI 71% to 82%) at 6 weeks and 6 months, respectively, and at 6 months 70% provided both cessation support resource use data and EuroQol-5 Dimensions five level (EQ-5D-5L) data. Among those self-reporting abstinence at 6 months follow-up, 39% (95% CI 24% to 54%) returned a viable sample for biochemical verification, although return rates were higher in the Quit Sense than the usual care arm (52% vs. 19%). Online recruitment was completed successfully within the planned 6-week period, split into two campaigns, with a per-participant cost of £19.20, split into advert (£5.82) and running costs (£13.38). In the Quit Sense arm, 75% (95% CI 67% to 83%) of participants installed the app and, of these, 100% set a quit date within the app and 51% (95% CI 39% to 63%) engaged with it for more than 1 week. At final follow-up, 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% CI 1.23 to 16.94). Similar effects were observed for biochemically verified secondary abstinence outcomes at 6-month follow-up and sensitivity analyses. Effect sizes were smaller and non-significant for self-report only abstinence and there was no evidence of a between-arm difference in abstinence at 6-week follow-up. Participants in the Quit Sense arm had higher rates of lapse avoidance in the first 2 weeks of their quit attempt or post enrolment compared to usual care though this was not statistically significant (29.6% vs. 19.2%; p = 0.14). There was no evidence of between-arm differences in hypothesised mechanisms of action of the app, including the mean frequency of lapse prevention strategy use [mean difference (MD) −0.07; p = 0.46], smoking cessation self-efficacy (MD 0.18; p = 0.39), strength (p = 0.23) and frequency (p = 0.83) of urges to smoke or the Wisconsin Inventory of Smoking Dependence Motives subscales of automaticity (p = 0.51) and associative processes (p = 0.58). The qualitative process evaluation identified several potential pathways to abstinence among Quit Sense arm participants. Interviewed participants reported finding the insights gained from engaging with the smoking behaviour learning tool before their quit attempt started particularly valuable. They reported that this reinforced their commitment to quit, helped them better understand the drivers of their smoking behaviour and challenged the need for them to smoke. Some also reported finding regular and location-specific support messages encouraging and motivational and that this reinforced the goal of quitting and made them feel equipped when they spent time in locations that they used to smoke in. Participants highlighted several factors which led to disengagement with the app, including relapse, no longer feeling they needed support, not finding the app met their needs and technical issues. Participants also provided suggestions for app improvement relating to logging smoking, adding gamification elements and improved support triggering. Interviewed participants from both arms highlighted how COVID-19 measures had affected their smoking behaviour and restricted the time they spent outside of their home, which would have had implications for location-based cessation support. In terms of the main cost-drivers, e-cigarettes/vaporisers and nicotine replacement therapy accounted for more than 70% of the total non-intervention costs. The total intervention cost (recruitment advertising and maintaining the Quit Sense app) was estimated to be £28.51 per participant. In both groups, the mean EQ-5D-5L score at both 6-week and 6-month follow-up was lower than that at baseline. A preliminary cost-effectiveness analysis using EQ-5D-5L score as the outcome estimated that the intervention was both more costly and less effective, compared to standard care, though there was no significant difference in cost or effect between the two groups. The SWAT analysis indicated that increasing the incentive for completing follow-up from £10 to £20 did not increase response rates at 6 months (74% vs. 79%; p = 0.36) but did reduce the proportion of participants requiring manual follow-up (62% vs. 46%; p = 0.018) and the median response time to responding (15 days vs. 7 days; p = 0.016). Conclusions: The Quit Sense RCT design and procedures demonstrated feasibility and generated preliminary efficacy evidence of the app on abstinence at 6-month follow-up, although how the app may achieve this is not clear. Three out of the four pre-specified feasibility progression criteria for moving to a definitive trial – completion rate of self-reported abstinence at final follow-up and the rate of Quit Sense installation and engagement – were met. The return of saliva samples among quitters was lower than anticipated, though this can likely be increased in a future trial through increased incentivisation and enhanced procedures. Progression to a definitive trial is warranted. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy. Trial registration ISRCTN48600346