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

Felix Naughton, Sue Cooper, Katharine Foster, Joanne Emery, Jo Leonardi-Bee, Stephen Sutton, Matthew Jones, Michael Ussher, Rachel Whitemore, Matthew Leighton, Alan Montgomery, Steve Parrott, Tim Coleman, Felix Naughton, Sue Cooper, Katharine Foster, Joanne Emery, Jo Leonardi-Bee, Stephen Sutton, Matthew Jones, Michael Ussher, Rachel Whitemore, Matthew Leighton, Alan Montgomery, Steve Parrott, Tim Coleman

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.

Keywords: SMS text messaging; mHealth; pregnancy; randomized controlled trial; self-help; smoking cessation.

© 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Figures

Figure 1
Figure 1
Trial flow. *Includes 17 MiQuit participants without 4‐week follow up data; **includes 14 usual care participants without 4‐week follow‐up data

References

    1. Pineles B. L., Park E., Samet J. M. Systematic review and meta‐analysis of miscarriage and maternal exposure to tobacco smoke during pregnancy. Am J Epidemiol 2014; 179: 807–823.
    1. Moore E., Blatt K., Chen A., Van H. J., Defranco E. A. Relationship of trimester specific smoking patterns and risk of preterm birth. Am J Obstet Gynecol 2016; 215: 109.e1–6.
    1. Flenady V., Koopmans L., Middleton P., Froen J. F., Smith G. C., Gibbons K. et al. Major risk factors for stillbirth in high‐income countries: a systematic review and meta‐analysis. Lancet 2011; 377: 1331–1340.
    1. Hogberg L., Cnattingius S. The influence of maternal smoking habits on the risk of subsequent stillbirth: is there a causal relation? Br J Obstet Gynaecol 2007; 114: 699–704.
    1. NHS Information Centre . Infant feeding survey 2010: early results. Leeds: NHS Information Centre; 2011.
    1. Raisanen S., Kramer M. R., Gissler M., Saari J., Hakulinen‐Viitanen T., Heinonen S. Smoking during pregnancy was up to 70% more common in the most deprived municipalities—a multilevel analysis of all singleton births during 2005–2010 in Finland. Prev Med 2014; 67: 6–11.
    1. Hawkins S. S., Baum C. F. Impact of state cigarette taxes on disparities in maternal smoking during pregnancy. Am J Public Health 2014; 104: 1464–1470.
    1. Weden M. M., Miles J. N. Intergenerational relationships between the smoking patterns of a population‐representative sample of US mothers and the smoking trajectories of their children. Am J Public Health 2012; 102: 723–731.
    1. Leonardi‐Bee J., Jere M. L., Britton J. Exposure to parental and sibling smoking and the risk of smoking uptake in childhood and adolescence: a systematic review and meta‐analysis. Thorax 2011; 66: 847–855.
    1. Chamberlain C., O'Mara‐Eves A., Oliver S., Caird J. R., Perlen S. M., Eades S. J. et al. Psychosocial interventions for supporting women to stop smoking in pregnancy. Cochrane Database Syst Rev 2013; Issue 10 Art. No.: CD001055. .
    1. National Institute for Health and Clinical Excellence (NICE) . Quitting Smoking in Pregnancy and Following Childbirth: NICE Public Health Guidance 26. London: NICE; 2010.
    1. Naughton F., Prevost A. T., Sutton S. Self‐help smoking cessation interventions in pregnancy: a systematic review and meta‐analysis. Addiction 2008; 103: 566–579.
    1. Whittaker R., McRobbie H., Bullen C., Rodgers A., Gu Y. Mobile phone‐based interventions for smoking cessation. Cochrane Database Syst Rev 2016; Issue 4 Art. No.: CD006611. .
    1. Curry S. J., McBride C., Grothaus L., Lando H., Pirie P. Motivation for smoking cessation among pregnant women. Psychol Addict Behav 2001; 15: 126–132.
    1. Dijkstra A., Ballast K. Personalization and perceived personal relevance in computer‐tailored persuasion in smoking cessation. Br J Health Psychol 2012; 17: 60–73.
    1. Craig P., Dieppe P., Macintyre S., Michie S., Nazareth I., Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008; 337: a1655.
    1. Naughton F., Jamison J., Sutton S. Attitudes towards SMS text message smoking cessation support: a qualitative study of pregnant smokers. Health Educ Res 2013; 28: 911–922.
    1. Naughton F., Prevost A. T., Gilbert H., Sutton S. Randomised controlled trial evaluation of a tailored leaflet and SMS text message self‐help intervention for pregnant smokers (MiQuit). Nicotine Tob Res 2012; 14: 569–577.
    1. Cooper S., Foster K., Naughton F., Leonardi‐Bee J., Sutton S., Ussher M. et al. Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial. Trials 2015; 16: 29.
    1. Bandura A. Social Foundations of Thought and Action: A Social Cognitive Theory. Englewood Cliffs. NJ: Prentice‐Hall; 1986.
    1. Petty R. E., Cacioppo J. T. Communication and Persuasion: Central and Peripheral Routes to Attitude Change. New York: Springer‐Verlag; 1986.
    1. Naughton F., Cooper S., Bowker K., Campbell K., Sutton S., Leonardi‐Bee J. et al. Adaptation and uptake evaluation of an SMS text message smoking cessation programme (MiQuit) for use in antenatal care. BMJ Open 2015; 5: e008871.
    1. Department for Communities and Local Government . English Indices of Deprivation 2010. 2011. Available at: (accessed 15 August 2016) (Archived at ).
    1. Heatherton T. F., Kozlowski L. T., Frecker R. C., Rickert W., Robinson J. Measuring the heaviness of smoking: using self‐reported time to the first cigarette of the day and number of cigarettes smoked per day. Br J Addict 1989; 84: 791–799.
    1. West R., Hajek P. Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology (Berl) 2004; 177: 195–199.
    1. Brooks R. EuroQol: the current state of play. Health Policy 1996; 37: 53–72.
    1. West R., Hajek P., Stead L., Stapleton J., West R., Hajek P. et al. Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction 2005; 100: 299–303.
    1. SRNT Subcommittee on Biochemical Verification . Biochemical verification of tobacco use and cessation. Nicotine Tob Res 2002; 4: 149–159.
    1. Firth D. Bias reduction of maximum likelihood estimates. Biometrika 1993; 80: 27–38.
    1. Heinze G., Schemper M. A solution to the problem of separation in logistic regression. Stat Med 2002; 21: 2409–2419.
    1. Schneider S., Huy C., Schutz J., Diehl K. Smoking cessation during pregnancy: a systematic literature review. Drug Alcohol Rev 2010; 29: 81–90.
    1. Riaz M., Lewis S., Coleman T., Aveyard P., West R., Naughton F. et al. Which measures of cigarette dependence are predictors of smoking cessation during pregnancy? Analysis of data from a randomized controlled trial. Addiction 2016; 111: 1656–1665.
    1. Dienes Z. Make the most of your data with Bayes. Available at: (accessed 15 August 2016) (Archived at ).
    1. Briggs A. H., Wonderling D. E., Mooney C. Z. Pulling cost‐effectiveness analysis up by its bootstraps: a non‐parametric approach to confidence interval estimation. Health Econ 1997; 6: 327–340.
    1. Rouder J. N., Speckman P. L., Sun D., Morey R. D., Iverson G. Bayesian t‐tests for accepting and rejecting the null hypothesis. Psychon Bull Rev 2009; 16: 225–237.
    1. Free C., Knight R., Robertson S., Whittaker R., Edwards P., Weiwei Z. et al. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single‐blind, randomised trial. Lancet 2011; 378: 49–55.
    1. Abroms L. C., Boal A. L., Simmens S. J., Mendel J. A., Windsor R. A. A randomized trial of Text2Quit: a text messaging program for smoking cessation. Am J Prev Med 2014; 47: 242–250.
    1. Tappin D., Bauld L., Purves D., Boyd K., Sinclair L., MacAskill S. et al. Financial incentives for smoking cessation in pregnancy: randomised controlled trial. BMJ 2015; 350: h134.
    1. Boyd K. A., Briggs A. H., Bauld L., Sinclair L., Tappin D. Are financial incentives cost‐effective to support smoking cessation during pregnancy? Addiction 2016; 111: 360–370.
    1. Venn A., Dickinson A., Murray R., Jones L., Li J., Parrott S. et al. Effectiveness of a mobile, drop‐in stop smoking service in reaching and supporting disadvantaged UK smokers to quit. Tob Control 2016; 25: 33–38.
    1. Dobbie F., Hiscock R., Leonardi‐Bee J., Murray S., Shahab L., Aveyard P. et al. Evaluating long‐term outcomes of NHS stop smoking services (ELONS): a prospective cohort study. Health Technol Assess 2015; 19: 1–156.
    1. Cromwell J., Bartosch W. J., Fiore M. C., Hasselblad V., Baker T. Cost‐effectiveness of the clinical practice recommendations in the AHCPR guideline for smoking cessation. Agency for Health Care Policy and Research. JAMA 1997; 278: 1759–1766.
    1. Fiscella K., Franks P. Cost‐effectiveness of the transdermal nicotine patch as an adjunct to physicians’ smoking cessation counseling. JAMA 1996; 275: 1247–1251.
    1. Jones M., Lewis S., Parrott S., Wormall S., Coleman T. Re‐starting smoking in the postpartum period after receiving a smoking cessation intervention: a systematic review. Addiction 2016; 111: 981–990.
    1. Berrueta M., Morello P., Aleman A., Tong V. T., Johnson C., Dietz P. M. et al. Smoking patterns and receipt of cessation services among pregnant women in Argentina and Uruguay. Nicotine Tob Res 2016; 18: 1116–1125.
    1. NHS Information Centre . Statistics on NHS stop smoking Services in England, April 2014 to march 2015. Leeds: Health and Social Care Information Centre; 2015.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren