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.

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.

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.

Comparison of a Daily Smartphone App and Retrospective Questionnaire Measures of Adherence to Nicotine Replacement Therapy Among Pregnant Women: Observational Study.

BACKGROUND: Few studies have investigated how to best measure adherence to smoking cessation medications, but continuous usage measures are recommended. OBJECTIVE: In this first study of its kind, we compared methods for measuring adherence to nicotine replacement therapy (NRT) among pregnant women, investigating the completeness and validity of data collected from daily assessments using a smartphone app versus data collected from retrospective questionnaires. METHODS: Women aged ≥16 years who were daily smokers and <25 weeks pregnant were offered smoking-cessation counseling and encouraged to use NRT. For 28 days after setting a quit date (QD), women were asked to report NRT use daily to a smartphone app and to questionnaires administered in person or remotely at 7 and 28 days. For both data collection methods, we provided up to £25 (~US $30) as compensation for the time taken providing research data. Data completeness and NRT use reported to the app and in questionnaires were compared. For each method, we also correlated mean daily nicotine doses reported within 7 days of the QD with Day 7 saliva cotinine concentrations. RESULTS: Of the 438 women assessed for eligibility, 40 participated and 35 accepted NRT. More participants (31/35) submitted NRT usage data to the app by Day 28 (median 25, IQR 11 days) than completed the Day 28 questionnaire (24/35) or either of the two questionnaires (27/35). Data submitted to the app showed a lower reported duration of NRT use compared to that indicated in the questionnaire (median for app 24 days, IQR 10.25; median for questionnaire 28 days, IQR 4.75; P=.007), and there appeared to be specific cases of overreporting to the questionnaire. Mean daily nicotine doses between the QD and Day 7 were lower when calculated using app data (median for app 40 mg, IQR 52.1; median for questionnaire 40 mg, IQR 63.1; P=.001), and some large outliers were evident for the questionnaire. Mean daily nicotine doses, adjusted for cigarettes smoked, were not associated with cotinine concentrations for either method (app rs=0.184, P=.55; questionnaire rs=0.031, P=.92), but the small sample size meant that the analysis was likely underpowered. CONCLUSIONS: Daily assessment of NRT use via a smartphone app facilitated more complete data (a higher response rate) than questionnaires, and reporting rates over 28 days were encouraging among pregnant women. App data had better face validity; retrospective questionnaires appeared to overestimate NRT use for some participants.

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.

Developing a taxonomy to describe offspring outcomes in studies involving pregnant mammals' exposure to non-tobacco nicotine: A systematic scoping review.

INTRODUCTION: Many countries recommend Nicotine Replacement Therapy (NRT) for smoking cessation in pregnancy. Preclinical studies of nicotine exposure to pregnant mammals could indicate how nicotine may adversely affect the developing fetus. As a first step towards summarising this literature, we undertook a systematic scoping review to determine the number and nature of offspring outcomes studied. METHODS: We searched MEDLINE and EMBASE databases for papers reporting empirical data on offspring outcomes following nicotine exposure to pregnant non-human mammals. We excluded studies that investigated exposure to only smoking, e-cigarettes, nicotine vaccines, or studies with no 'nicotine only' group. We developed a draft taxonomy and using this, described and quantified outcomes reported. RESULTS: We identified 476 studies, which reported 729 offspring outcomes. The draft taxonomy classified outcomes as being measured in i) whole animals, ii) body systems and iii) 'other'. Body system outcomes were further categorised as being functional changes, or changes at macroscopic or cellular levels. The most frequently used outcomes were those detecting changes in the brain (n = 265), physical parameters measured in whole animals (n = 122) and any respiratory system changes (n = 97). CONCLUSIONS: This scoping review quantifies the nature and frequency of outcomes used in preclinical studies investigating the potential impacts of nicotine administration in pregnancy on offspring. Systematic reviews of studies investigating outcomes involving animal brains, respiratory system, or 'whole animal' outcomes may have greatest potential for further advancing knowledge regarding impacts of gestational nicotine exposure on offspring. PROTOCOL AND REGISTRATION: Protocol for this review can be found on Open Science Framework (https://osf.io/ptmzc/).

The development and acceptability testing of an app-based smart survey system to record smoking behaviour, use of nicotine replacement therapy (NRT) and e-cigarettes.

OBJECTIVE: Nicotine replacement therapy (NRT) helps people stop smoking. Monitoring treatment adherence is important as poor adherence to NRT limits its effectiveness. As e-cigarettes contain nicotine, their use ('vaping') is likely to affect both NRT use and smoking. We wished to measure adherence to NRT, and to investigate relationships between NRT, vaping and smoking so we developed 'NicUse', a smartphone App linked to a cloud database for collecting data relevant to NRT adherence. We report user-acceptability and investigate data validity among pregnant people by comparing heaviness of smoking reported to NicUse surveys with contemporaneous exhaled carbon monoxide readings. RESULTS: Thirty five pregnant women participating in a pilot study were asked to install and use NicUse on their smartphones. 32/35 (91%) logged into NicUse, 31 (89%) completed one or more surveys, and 22 (63%) completed these on ≥ 20 of 28 study days. Twenty-four gave end-of-study user acceptability ratings; 23 (96%) agreed or strongly agreed NicUse was 'Easy to use' and 'Instructions were clear'. There was a strong correlation between the number of daily cigarettes reported on NicUse and exhaled CO readings taken on study Day 7 (Pearson's r = 0.95, p < 0.001). NicUse appears highly acceptable, and smoking data reported to it shows validity.

Smoking Cessation Support for Pregnant Women Provided by English Stop Smoking Services and National Health Service Trusts: A Survey.

Reducing smoking rates in pregnancy continues to be a public health priority. Given a recent UK government policy change resulting in The National Health Service (NHS) making a significant new contribution to cessation support in pregnancy in England, in addition to that of Local Authorities (LA), an up-to-date assessment of national support offered to pregnant women is needed. LA Stop Smoking Service (SSS) managers and representatives from maternity services in NHS Trusts were invited to participate in an online survey in autumn 2020. Topics included service configuration, staffing, practitioner consultations and treatments offered. The survey response rate was 66% (99/151) of LAs and 68% (95/140) of Trusts. Most LAs provided smoking support for pregnant smokers (78%), whereas under half (43%) of NHS Trusts did. Combination nicotine replacement therapy, i.e., a combination of a patch and short-acting product, was offered by LAs (92%) and Trusts (95%) and most commonly for 12 weeks duration, at 53% and 50%, respectively. Similar national online training was undertaken by those supporting women, with the majority undertaking the specialist pregnancy-specific module: LAs 60% and Trusts 79%. However, clinicians were reported to deliver specialist stop smoking support in over 50% of Trusts, whereas this was reported in only 16% of LAs. In England, both LA and NHS Trusts are currently delivering similar stop smoking support to pregnant women. Having nationally recognised treatment programmes and training allows for the delivery of consistent, evidence-based smoking cessation to pregnant women in different healthcare settings.

Comparison of saliva cotinine and exhaled carbon monoxide concentrations when smoking and after being offered dual nicotine replacement therapy in pregnancy.

BACKGROUND AND AIMS: Although English Stop Smoking Services routinely offer dual nicotine replacement therapy (NRT) to help pregnant women to quit smoking, little is known about how nicotine and tobacco smoke exposures following this compare with that from smoking. We compared, in pregnant women when smoking and after being offered dual NRT, saliva cotinine and exhaled carbon monoxide (CO) concentrations and numbers of daily cigarettes smoked. DESIGN AND SETTING: Secondary analysis of data from three sequential, observational, mixed-methods cohort studies conducted as part of the Nicotine Replacement Effectiveness and Delivery in Pregnancy programme. Participants were recruited on-line or in Nottingham University Hospitals (UK) antenatal clinics between June 2019 and September 2020. PARTICIPANTS: Forty pregnant women, who agreed to try stopping smoking. INTERVENTION: Participants were offered dual NRT, agreed a smoking quit date and received an intervention to improve adherence to NRT. MEASUREMENTS: Saliva cotinine and exhaled CO concentrations and reported number of cigarettes smoked per day. FINDINGS: There were no differences in saliva cotinine concentrations at baseline and day 7 post quit date [n = 20, mean difference = -32.31 ng/ml, 95% confidence interval (CI) = -68.11 to 3.5 ng/ml; P = 0.074, Bayes factor = 0.04]. There were reductions in the reported number of cigarettes smoked per day (n = 26, mean difference = -7 cigarettes, 95% CI = -8.35 to -5.42 cigarettes, P < 0.001) and concurrently in exhaled CO concentrations (n = 17, ratio of geometric means = 0.30 p.p.m., 95% CI = 0.17-0.52 p.p.m.; P < 0.001). CONCLUSION: Pregnant women who smoke and are offered dual nicotine replacement therapy (NRT) appear to show no change in their exposure to cotinine compared with their pre-NRT exposure levels but they report smoking fewer cigarettes, as validated by reductions in exhaled carbon monoxide concentrations.

Agreement and Disparities between Women and Stop-Smoking Specialists about How to Promote Adherence to Nicotine Replacement Therapy in Pregnancy.

Evidence for the effectiveness of nicotine replacement therapy (NRT) for smoking-cessation in pregnancy is weak. This has been attributed to insufficient dosing and low adherence. This study investigated the acceptability of key messages and delivery modes for a behavioral intervention to increase NRT adherence in pregnancy. Semi-structured telephone interviews were carried out with pregnant or postpartum women aged ≥16 from across England, who had been offered NRT during pregnancy as part of a quit attempt and who struggled to quit (n = 10), and a focus group with stop-smoking specialists from across England (n = 6). The two data sources were coded separately using a thematic approach and then integrated to compare perspectives. Women and specialists agreed on message tone and delivery modes. However, views diverged on the most influential sources for certain messages and whether some information should be given proactively or reactively. There was also disagreement over which messages were novel and which were routinely delivered. This study demonstrates the value of capturing and integrating different perspectives and informational requirements when developing behavior-change interventions. The findings provide useful insights for designing a pregnancy-specific NRT adherence intervention that is acceptable to both those who will deliver and receive it.

Understanding pregnant women's adherence-related beliefs about Nicotine Replacement Therapy for smoking cessation: A qualitative study.

INTRODUCTION: Reducing smoking during pregnancy is a public health priority. Nicotine replacement therapy (NRT) is offered routinely to pregnant women who smoke in the United Kingdom. However, evidence of treatment efficacy in this population is weak, most likely due to poor adherence. Guided by the Necessity-Concerns Framework, we conducted a qualitative study to better understand pregnant women's perceived needs and concerns regarding NRT use, with consideration of combination NRT. METHODS: Semi-structured interviews were conducted by telephone with 18 pregnant or recently pregnant women in England and Wales, purposively sampled for different NRT-related experiences. Participants were recruited online via Facebook adverts and through a Stop Smoking Service. A hybrid approach of deductive and inductive thematic coding was used for analysis. RESULTS: Findings were organized around three themes: 1) the role of motivation to stop smoking; 2) necessity beliefs about using NRT; and 3) concerns about NRT. Some women reported fluctuating motivation for stopping smoking which undermined their NRT use. Others used NRT to cut down the number of cigarettes they smoked. Reasons for low NRT necessity beliefs included a preference for quitting unassisted, low or unrealistic expectations of efficacy, and overconfidence in achieving cessation (necessity testing). Concerns included safety, particularly around increased nicotine exposure with combination NRT, addictiveness, side effects, and capability to use. CONCLUSION: Pregnant women have multiple necessity beliefs and concerns that influence their use of NRT. Targeting these, alongside increasing and maintaining motivation to quit smoking, will likely help optimize NRT use in pregnancy and improve quit rates.

Practitioners' Views on Nicotine Replacement Therapy in Pregnancy during Lapse and for Harm Reduction: A Qualitative Study.

Many countries, including the UK, recommend nicotine replacement therapy (NRT) for smoking cessation during pregnancy. However, adherence to NRT is generally low, smoking lapse or relapse is common and using NRT to reduce the harm from the number of cigarettes smoked is only advocated in non-pregnant smokers. Two focus groups were conducted with 13 professionals involved in antenatal stop smoking services (SSS). The data were analysed thematically. Two themes were extracted that describe health professionals' attitudes towards using NRT either during lapses or to reduce smoking in women who cannot quit (harm reduction). These are presented around a social-ecological framework describing three hierarchical levels of influence within smoking cessation support: (1) Organizational: providing NRT during lapses could be expensive for SSS though harm reduction could result in services helping a wider range of clients. (2) Interpersonal: participants felt using NRT for harm reduction was not compatible with cessation-orientated messages practitioners conveyed to clients. (3) Individual: practitioners' advice regarding using NRT during smoking lapses varied; many were generally uncomfortable about concurrent smoking and NRT use and had strong reservations about recommending NRT when smoking during all but the briefest lapses. Further evidence is required to guide policy and practice.

Knowledge and Education as Barriers and Facilitators to Nicotine Replacement Therapy Use for Smoking Cessation in Pregnancy: A Qualitative Study with Health Care Professionals.

Smoking during pregnancy is a leading cause of negative pregnancy and perinatal outcomes. While UK guidelines recommend nicotine replacement therapy (NRT) for smoking cessation during pregnancy, adherence to NRT is generally low and may partially explain why NRT appears less effective in pregnancy compared to non-pregnant smokers. This study aimed to identify and describe factors associated with NRT adherence from a health professional's perspective. Two focus groups and one expert group were conducted with 26 professionals involved in antenatal stop smoking services and the data were analysed thematically using a template methodology. From our analyses, we extracted two main themes: (i) 'Barriers to NRT use in pregnancy' explores the issues of how misinformation and unrealistic expectations could discourage NRT use, while (ii) 'Facilitators to NRT use in pregnancy' describes the different information, and modes of delivery, that stop smoking professionals believe will encourage correct and sustained NRT use. Understanding the barriers and facilitators to improve NRT adherence may aid the development of educational interventions to encourage NRT use and improve outcomes for pregnant women wanting to stop smoking.

Uptake of Tailored Text Message Smoking Cessation Support in Pregnancy When Advertised on the Internet (MiQuit): Observational Study.

BACKGROUND: Smoking in pregnancy is a major public health concern. Pregnant smokers are particularly difficult to reach, with low uptake of support options and few effective interventions. Text message-based self-help is a promising, low-cost intervention for this population, but its real-world uptake is largely unknown. OBJECTIVE: The objective of this study was to explore the uptake and cost-effectiveness of a tailored, theory-guided, text message intervention for pregnant smokers ("MiQuit") when advertised on the internet. METHODS: Links to a website providing MiQuit initiation information (texting a short code) were advertised on a cost-per-click basis on 2 websites (Google Search and Facebook; £1000 budget each) and free of charge within smoking-in-pregnancy webpages on 2 noncommercial websites (National Childbirth Trust and NHS Choices). Daily budgets were capped to allow the Google and Facebook adverts to run for 1 and 3 months, respectively. We recorded the number of times adverts were shown and clicked on, the number of MiQuit initiations, the characteristics of those initiating MiQuit, and whether support was discontinued prematurely. For the commercial adverts, we calculated the cost per initiation and, using quit rates obtained from an earlier clinical trial, estimated the cost per additional quitter. RESULTS: With equal capped budgets, there were 812 and 1889 advert clicks to the MiQuit website from Google (search-based) and Facebook (banner) adverts, respectively. MiQuit was initiated by 5.2% (42/812) of those clicking via Google (95% CI 3.9%-6.9%) and 2.22% (42/1889) of those clicking via Facebook (95% CI 1.65%-2.99%). Adverts on noncommercial webpages generated 53 clicks over 6 months, with 9 initiations (9/53, 17%; 95% CI 9%-30%). For the commercial websites combined, mean cost per initiation was £24.73; estimated cost per additional quitter, including text delivery costs, was £735.86 (95% CI £227.66-£5223.93). Those initiating MiQuit via Google were typically very early in pregnancy (median gestation 5 weeks, interquartile range 10 weeks); those initiating via Facebook were distributed more evenly across pregnancy (median gestation 16 weeks, interquartile range 14 weeks). CONCLUSIONS: Commercial online adverts are a feasible, likely cost-effective method for engaging pregnant smokers in digital cessation support and may generate uptake at a faster rate than noncommercial websites. As a strategy for implementing MiQuit, online advertising has large reach potential and can offer support to a hard-to-reach population of smokers.

Cognitive and Behavioral Predictors of Quit Attempts and Biochemically-Validated Abstinence During Pregnancy.

INTRODUCTION: Initiating a quit attempt and achieving abstinence are distinct behaviors that have distinct correlates in general smokers. Studies predicting prenatal smoking have not addressed this. METHODS: Pregnant smokers (N = 207), recruited to a cessation intervention trial, were used as an observational cohort. Women completed measures at baseline and 12-week follow-up (mid-late pregnancy). Outcomes were having made at least one quit attempt since baseline, and cotinine-validated 7-day abstinence at follow-up in attempters. Baseline predictors included demographics (age, deprivation, partner's smoking), smoking behaviors (nicotine dependence, quit attempt history, previous prenatal smoking), and smoking beliefs (self-efficacy, determination, intention to quit, nonsmoker identity, social support, pregnancy-outcome beliefs). For each outcome, variables reaching p < .1 in logistic regression analyses were entered into a multivariate model controlling for trial arm. A complete case analysis was undertaken, with missing data assumptions tested in sensitivity analyses. RESULTS: One hundred seventy-five women (85%) completed follow-up. Intention and determination to quit (p < .001), self-efficacy, nonsmoker identity, and not having previously smoked in pregnancy (p < .05) were univariate predictors of making a quit attempt, with stronger intention to quit the only independent predictor (multivariate odds ratio [OR] = 2.41, 95% confidence interval [CI] 1.19-4.87). Only nicotine dependence predicted validated abstinence among those who made a quit attempt (multivariate OR = 0.25, 95% CI 0.10-0.60). CONCLUSIONS: Initiating a quit attempt and achieving abstinence during pregnancy were found to have different correlates. For women yet to make a quit attempt in their pregnancy, smoking beliefs may be important intervention targets, but once they are engaged in quitting, nicotine dependence appears of prime importance. IMPLICATIONS: This study suggests that cognitive, particularly motivational, variables predict whether pregnant smokers will make a quit attempt, but they do not predict successful abstinence in those who attempt to quit, where nicotine dependence dominates. Interventions should facilitate quit attempts by targeting motivational variables among pregnant women who continue to smoke, but should focus on managing withdrawal once a woman initiates a quit attempt.

Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

AIMS: To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. DESIGN: Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. SETTING: Sixteen antenatal clinics in England. PARTICIPANTS: Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. INTERVENTION: All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). OUTCOME MEASUREMENTS: Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. FINDINGS: Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). CONCLUSIONS: There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care.