The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit). These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.
Epidemiological evidence indicates that smoking during pregnancy increases the risk of many pregnancy related complications and is associated with many adverse postnatal problems. Around 15% of women still smoke throughout their pregnancy; younger women and those from more deprived backgrounds are much more likely to smoke. Behavioural support, available through NHS Stop Smoking Services, is effective but only accessed by a minority of smokers with most trying to quit alone. For this large group, self-help interventions may be an effective alternative. MiQuit is a 12 week tailored, self-help, text-message intervention developed for pregnant smokers. A pilot study found this was feasible and acceptable for recipients, thus if MiQuit could have such an impact in routine NHS care, its low cost would make it highly cost-effective. Before MiQuit could be used in routine care, a definitive randomised controlled trial (RCT) would be needed but currently there is insufficient information to justify conducting this. This pilot trial will investigate whether it is possible to evaluate MiQuit in a multi-centre RCT located within the NHS, using research network resources. This study will recruit 400 pregnant smokers who will be randomly allocated to either MiQuit or control, and will provide estimates for the parameters required for determining the necessary resources for a definitive trial. These include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of trial participants in later pregnancy and ascertainment rates obtained; and the likely effect of MiQuit when women are offered this in NHS settings. Secondary objectives include; To estimate and model the likely effectiveness and cost effectiveness of MiQuit compared with usual care including a generic smoking cessation information leaflet; To document participants' use of MiQuit interactive features and of NHS cessation support; To assess the effect of MiQuit on social cognitive determinants of quitting smoking and; To explore participant views and experiences of using MiQuit. The participants will be recruited before 25 weeks gestation when they attend NHS hospital clinics for routine antenatal ultrasound scans. Recruitment will take place in around 12 United Kingdom (UK) centres over a 12 month period. Follow-up will be via telephone at 1 month after randomization and again at week 36 gestation. The follow-up is over a 9 month period. If a participant reports they have stopped smoking, this "quit" will be validated with a exhaled Carbon Monoxide (CO) measurement and/or salivary cotinine measurement. A small number of semi-structured telephone interviews will be carried out with a selection of participants from the MiQuit arm to explore their views and experience of the intervention.
MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement.
Mid Cheshire Hospitals NHS Foundation Trust
Crewe, Cheshire, United Kingdom
Chesterfield Royal Hospitals NHS Foundation Trust
Chesterfield, Derbyshire, United Kingdom
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy.
The primary smoking outcome measure will be the number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation.
Time frame: 36 weeks gestation
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report.
The number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), self-reported.
Time frame: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report.
The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), self-reported.
Time frame: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated.
The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation.
Time frame: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report.
The number of participants reporting 7-day abstinence from smoking at 4 weeks after randomisation, self-reported.
Time frame: 4 weeks post-randomisation
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
407
Derby Hospitals NHS Foundation Trust
Derby, Derbyshire, United Kingdom
United Lincolnshire Hospitals NHS Trust
Boston, Lincolnshire, United Kingdom
United Lincolnshire Hospitals NHS Trust
Lincoln, Lincolnshire, United Kingdom
Nottingham University Hospitals NHS Trust, City Hospital
Nottingham, Nottinghamshire, United Kingdom
Nottingham University Hospitals NHS Trust, QMC
Nottingham, Nottinghamshire, United Kingdom
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, Nottinghamshire, United Kingdom
University Hospital of North Staffordhsire NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom
Birmingham Womens NHS Foundation Trust
Birmingham, W Midlands, United Kingdom
...and 5 more locations
7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report.
The number of participants reporting 7-day abstinence from smoking at both 4 weeks after randomisation and at follow up at the end of pregnancy (approximately 36 weeks gestation), self-reported.
Time frame: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy.
The number of participants reporting 7-day abstinence from smoking at both 4 weeks after randomisation and at follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation.
Time frame: 36 weeks gestation
Number of 24 Hour Quit Attempts
Number of short-term, 24 hour quit attempts noted per participant, from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation).
Time frame: 36 weeks gestation
Reported Use of NHS and Other (Non-trial) Cessation Support
Reported use of any NHS cessation support or other (non-trial) cessation support (e.g. non-NHS websites), from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation).
Time frame: 36 weeks gestation
Number of Requests to Stop Text Support
The number of participants in the trial arm who discontinued the text support prematurely, from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation).
Time frame: 36 weeks gestation