Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Naughton F

PROVIDER: S-EPMC5488183 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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

Naughton Felix F Cooper Sue S Foster Katharine K Emery Joanne J Leonardi-Bee Jo J Sutton Stephen S Jones Matthew M Ussher Michael M Whitemore Rachel R Leighton Matthew M Montgomery Alan A Parrott Steve S Coleman Tim T

Addiction (Abingdon, England) 20170502 7

<h4>Aims</h4>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.<h4>Design</h4>Multi-centre, parallel-group, single-blinded, individual randomized controlled trial.<h4>Setting</h4>Sixteen antenatal clinics in England.<h4>Participants</h4>Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were < 25 weeks ...[more]

PMID: 28239919

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Project description:BackgroundSmoking 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.ObjectiveThe 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.MethodsLinks 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.ResultsWith 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).ConclusionsCommercial 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.

Project description:Background and aimsPrevious evaluations of smoking cessation interventions in pregnancy have several limitations. Our solution to these limitations is the Economics of Smoking in Pregnancy (ESIP) model, which estimates the life-time cost-effectiveness of smoking cessation interventions in pregnancy from a National Health Service (NHS) and personal social services perspective. We aim to (1) describe how ESIP has been constructed and (2) illustrate its use with trial data.MethodsESIP links mothers' and offspring pregnancy outcomes to estimate the burdens of smoking-related disease they experience with different rates of smoking in pregnancy, both in pregnancy and throughout their life-times. Smoking rates are inputted by model users. ESIP then estimates the costs of treating disease burdens and also mothers' and offspring life-years and quality-adjusted life years (QALYs). By comparing costs incurred and healthy life following different smoking rates, ESIP estimates incremental cost-effectiveness and benefit-cost ratios for mothers or offspring or both combined. We illustrate ESIP use using data from a pragmatic randomized controlled trial that tested a smoking cessation intervention in pregnancy.ResultsThroughout women's and offspring life-times, the intervention proved cheaper than usual care, having a negative incremental cost of £38.37 (interquartile range = £21.46-56.96) and it improved health, demonstrating a 0.04 increase in incremental QALYs for mothers and offspring, implying that it is 'dominant' over usual care. Benefit-cost ratios suggested that every £1 spent would generate a median of £14 (interquartile range = £8-20) in health-care savings.ConclusionsEconomics of Smoking in Pregnancy is the first economic model to link mothers' and infants' costs and benefits while reporting cost-effectiveness in readily-comparable units. Using ESIP with data from a trial which reported only short-term economic analysis showed that the intervention was very likely to be cost-effective in the longer term and to generate health-care savings.

Project description:BACKGROUND:Smoking in pregnancy is a public health problem. Self-help smoking cessation support can help pregnant women to stop smoking, but the effects of delivering this kind of support via SMS text message are not known. A previous randomised controlled trial (RCT) demonstrated the feasibility and acceptability of providing such support to pregnant smokers using an automated, tailored text message intervention called MiQuit. This larger RCT will estimate key parameters for and will test the feasibility of delivering a major trial run within the United Kingdom National Health Service settings aimed at providing definitive evidence on the utility of MiQuit for helping pregnant smokers to stop. METHODS/DESIGN:This will be a multi-centre, parallel group RCT. Participants are being identified in 16 English antenatal care settings and must be >16 years old, pregnant, <25 weeks gestation, smoke >1 daily cigarette, have smoked >5 daily cigarettes before pregnancy, and able to understand texts in English. After consenting and the collection of baseline data, participants are randomised to control or intervention groups in a 1:1 ratio; randomisation is stratified by trial site and gestation and employs computer-generated pseudo-random code using random permuted blocks of randomly varying size, and held on a secure server. All participants receive a National Health Service (NHS) leaflet aimed at helping them to stop smoking. Intervention group women also receive the 12-week MiQuit programme of tailored, supportive, interactive text message, self-help cessation support. Women are followed up by telephone 4 weeks after randomisation and at 36 weeks gestation. The study aims to recruit 400 women, and with this sample we will be able to estimate trial centres' recruitment rates to within +/-1% (margin of error?=?half width of 95% confidence interval); individual trial groups' ascertainment of rates for smoking outcomes between 4 weeks after randomisation until approximately 36 weeks gestation to within +/-4%, and across both groups, the combined cessation rate at 36 weeks +/-3%. DISCUSSION:Pilot trial completion will provide data to facilitate planning for a definitive trial investigating whether MiQuit works for smoking cessation in pregnancy. TRIAL REGISTRATION:ClinicalTrials.gov NCT02043509 Registered 14 January 2014.

Project description:BackgroundSmoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy. A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called 'MiQuit' to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit's evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy.Methods/designThis is a multi-centre, parallel-group RCT. Pregnant women aged over 16 years, of less than 25 weeks' gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (< 16 weeks versus ≥ 16 weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4 weeks after randomisation and 36 weeks' gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ± 3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate.DiscussionIf effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking.Trial registrationClinicalTrials.gov, ID: NCT03231553 . Registered on 20 July 2017.

Project description:BackgroundInternet-based Smoking Cessation Interventions (ISCIs) may help pregnant smokers who are unable, or unwilling, to access face-to-face stop smoking support. Targeting ISCIs to specific groups of smokers could increase their uptake and effectiveness. The current study explored the needs and preferences of pregnant women seeking online stop smoking support with an aim to identify features and components of ISCIs that might be most attractive to this population.MethodsWe conducted qualitative interviews with thirteen pregnant women who completed the intervention arm of a pilot randomized controlled trial of a novel ISCI for pregnant smokers ('MumsQuit'). The interviews explored women's views towards MumsQuit and online support with quitting smoking in general, as well as their suggestions for how ISCIs could be best targeted to pregnancy. Interview transcripts were analyzed using Framework Analysis.ResultsParticipants expressed preferences for an accessible, highly engaging and targeted to pregnancy smoking cessation website, tailored to individuals' circumstances as well as use of cessation medication, offering comprehensive and novel information on smoking and quitting smoking in pregnancy, ongoing support with cravings management, as well as additional support following relapse to smoking. Participants also viewed as important targeting of the feedback and progress reports to baby's health and development, offering personal support from experts, and providing a discussion forum allowing for communication with other pregnant women wanting to quit .ConclusionsThe present study has identified a number of potential building blocks for ISCIs targeted to quitting smoking in pregnancy. Pregnant smokers willing to try using ISCI may particularly value an engaging intervention offering a high degree of targeting of comprehensive information to them as a group and tailoring support and advice to their individual needs, as well as one providing post-relapse support, peer-to-peer communication and personal support from experts.

Project description:IntroductionNegative affect has been identified as a factor influencing continued smoking during pregnancy. In this study, a multi-component emotion regulation intervention was developed to address negative emotional smoking triggers and pilot-tested among low-income pregnant smokers. Treatment feasibility and acceptability, cotinine-verified rates of smoking cessation, and self-report of mean cigarettes smoked were assessed.MethodsPregnant smokers who self-reported smoking in response to negative affect (N = 70) were randomly assigned to receive one of two 8-session interventions: (1) emotion regulation treatment combined with standard cognitive-behavioral smoking cessation (ERT + CBT) or (2) a health and lifestyle plus standard smoking cessation active control (HLS + CBT). Outcomes for the 4-month period following the quit date are reported.ResultsTreatment attendance and subjective ratings provide evidence for the feasibility and acceptability of the ERT + CBT intervention. Compared with the HLS + CBT control condition, the ERT + CBT condition demonstrated higher abstinence rates at 2 months (ERT + CBT = 23% vs. HLS + CBT = 0%, OR = 13.51; 95% CI = 0.70-261.59) and 4 months (ERT = 18% vs. HLS = 5%; OR = 2.98; 95% CI = 0.39-22.72) post-quit. Mean number of cigarettes per day was significantly lower in ERT + CBT at 2 months (ERT + CBT = 2.73 (3.35) vs. HLS + CBT = 5.84 (6.24); p = .05) but not at 4 months (ERT + CBT = 2.15 (3.17) vs. HLS + CBT = 5.18 (2.88); p = .06) post-quit.ConclusionsThe development and initial test of the ERT + CBT intervention supports its feasibility and acceptability in this difficult-to-treat population. Further development and testing in a Stage II randomized clinical trial are warranted.ImplicationsNegative affect has been identified as a motivator for continued smoking during pregnancy. To date, smoking cessation interventions for pregnant smokers have not specifically addressed the role of negative affect as a smoking trigger. This treatment development pilot study provides support for the feasibility and acceptability of a multi-component ERT + CBT for low-income pregnant smokers who self-report smoking in response to negative affect. Study findings support further testing in a fully-powered Stage II efficacy trial powered to assess mediators and moderators of treatment effects.

Project description:BackgroundDespite promising data in Western countries, there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other settings, including the Middle East, where smoking prevalence rates are higher.ObjectiveThis paper reports cessation rates observed in SMS Turkey, a text messaging-based smoking cessation program for adult smokers in Ankara, Turkey.MethodsThis study was a small-scale, parallel-group randomized controlled trial (RCT) conducted in Ankara, Turkey. Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara, Turkey. The text messaging intervention, SMS Turkey, provided 6 weeks of daily messages aimed at giving participants skills to help them quit smoking. Messages were sent in an automated fashion, except 2 days and 7 days after the initial quit day. On days 2 and 7, the research assistant manually assigned participants to content "paths" based on whether they were still not smoking or had relapsed. The control arm received a brochure that provided similar information about smoking cessation. The main outcome measure was self-reported 3-month sustained abstinence, verified by carbon monoxide (CO) readings. Neither participants nor researchers were blinded to arm assignment.ResultsThe 151 participants were randomly assigned to 1 of 2 groups: 76 to the SMS Turkey intervention group and 75 to the brochure control group. Using intention to treat, all 151 participants were included in analyses. Three-month cessation trends were not significantly higher in the intervention group: 11% intervention vs 5% control had quit (χ(2)(1)=1.4, P=.24; R(2)=2.0, 95% CI 0.62-6.3). When the sample was stratified by sex, female intervention participants (14%, n=5) were significantly more likely to have quit at 3 months than female control participants (0%, n=0; χ(2)(1)=3.7, P=.05). Among light smokers (ie, those smoking less than 20 cigarettes per day), intervention participants (17%, n=5) also were significantly more likely to have quit compared to control participants (0%, n=0; χ(2)(1)=5.3, P=.02). We noted no difference in cessation rates for males or heavy smokers. Participants experienced significant technology problems during the study. Some participants received duplicate text messages at least once during the trial; others failed to receive some program messages. Neither receiving duplicate messages (χ(2)(1)=0.12, P=.73), or missing 5 or more program messages (χ(2)(1)=0.75, P=.39) negatively affected quitting rates.ConclusionsAlthough the study was not powered to detect statistically significant differences, as the primary aim was to provide estimates of effect size that could be used to better inform a power analysis for a larger trial, findings provide optimism that SMS Turkey may be able to affect quitting rates in environments with high smoking prevalence, such as Ankara, Turkey. The SMS Turkey software program did not work as well as it did 2 years previous. The system will need to be updated to maintain software compatibility with ongoing technology evolution.Trial registrationClinicaltrials.gov NCT00912795 http://clinicaltrials.gov/ct2/show/NCT00912795 (Archived by WebCite® at http://www.webcitation.org/6Ch1cIA8l).

Dataset Information

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

Publications

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

Similar Datasets

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