title: Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Multi-centre, parallel-group, single-blinded, individual randomized controlled trial.
  
  
  METHODS
  Sixteen antenatal clinics in England.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
authors.affiliation: School of Health Sciences, University of East Anglia, Norwich, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Felix
authors.identifier: http://orcid.org/0000-0001-9790-2796
authors.initials: F
authors.lastname: Naughton
authors.affiliation: Division of Primary Care, University of Nottingham, Nottingham, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Sue
authors.identifier: http://orcid.org/0000-0002-1994-6395
authors.initials: S
authors.lastname: Cooper
authors.affiliation: Division of Primary Care, University of Nottingham, Nottingham, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Katharine
authors.initials: K
authors.lastname: Foster
authors.affiliation: Behavioural Science Group, University of Cambridge, Cambridge, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Emery
authors.affiliation: Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Jo
authors.initials: J
authors.lastname: Leonardi-Bee
authors.affiliation: Behavioural Science Group, University of Cambridge, Cambridge, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Sutton
authors.affiliation: Division of Primary Care, University of Nottingham, Nottingham, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Matthew
authors.identifier: http://orcid.org/0000-0002-4824-9724
authors.initials: M
authors.lastname: Jones
authors.affiliation: Population Health Research Institute, St George's University of London, London, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Ussher
authors.affiliation: Division of Primary Care, University of Nottingham, Nottingham, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Whitemore
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Leighton
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
authors.forename: Alan
authors.initials: A
authors.lastname: Montgomery
authors.affiliation: Department of Health Sciences, University of York, York, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: Parrott
authors.affiliation: Division of Primary Care, University of Nottingham, Nottingham, UK.|UK Centre for Tobacco and Alcohol Studies, University of Nottingham, Nottingham, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Coleman
mesh_terms: D000293:Adolescent; D000328:Adult; D001499:Bayes Theorem; D004739:England; D005260:Female; D015438:Health Behavior; D006801:Humans; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D011247:Pregnancy; D015397:Program Evaluation / Q000379:methods*; D012648:Self Care / Q000379:methods* / Q000706:statistics & numerical data; D016037:Single-Blind Method; D000074285:Smokers; D012907:Smoking / Q000628:therapy; D016540:Smoking Cessation / Q000379:methods* / Q000706:statistics & numerical data; D060145:Text Messaging; D055815:Young Adult
keywords: SMS text messaging; mHealth; pregnancy; randomized controlled trial; self-help; smoking cessation