Clinical trial NCT02043509: MiQuit Trial: Tailored Text Messages for Pregnant Women
Official title: Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Smoking
Keywords: smoking cessation
pregnancy
cessation support
tailored text messages
self-help
MiQuit
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2014-01-23
Enrollment: 407
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant and less than 25 weeks gestation
* Smoking at least 5 cigarettes per day pre-pregnancy
* Smoking at least 1 cigarette on a typical day during pregnancy
* Aged 16 or over
* Agrees to accept information to assist cessation
* Has own or has primary use of a mobile phone
* Familiar with sending and receiving text messages
* Able to understand written English (text messages are in English only) and consent issues explained in English.
* Able to give informed consent

Exclusion Criteria:

•Already enrolled in another text service to assist smoking cessation

Primary outcomes:
measure: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy.
timeFrame: 36 weeks gestation
Secondary outcomes:
measure: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report.
timeFrame: 36 weeks gestation
measure: 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report.
timeFrame: 36 weeks gestation
measure: 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated.
timeFrame: 36 weeks gestation
measure: 7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report.
timeFrame: 4 weeks post-randomisation
measure: 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report.
timeFrame: 36 weeks gestation
measure: 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy.
timeFrame: 36 weeks gestation
measure: Number of 24 Hour Quit Attempts
timeFrame: 36 weeks gestation
measure: Reported Use of NHS and Other (Non-trial) Cessation Support
timeFrame: 36 weeks gestation
measure: Number of Requests to Stop Text Support
timeFrame: 36 weeks gestation
Other outcomes:
Locations:
city: Crewe
country: United Kingdom
facility: Mid Cheshire Hospitals NHS Foundation Trust
state: Cheshire
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospitals NHS Foundation Trust
state: Derbyshire
city: Derby
country: United Kingdom
facility: Derby Hospitals NHS Foundation Trust
state: Derbyshire
city: Boston
country: United Kingdom
facility: United Lincolnshire Hospitals NHS Trust
state: Lincolnshire
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Hospitals NHS Trust
state: Lincolnshire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, City Hospital
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, QMC
state: Nottinghamshire
city: Sutton in Ashfield
country: United Kingdom
facility: Sherwood Forest Hospitals NHS Foundation Trust
state: Nottinghamshire
city: Stoke on Trent
country: United Kingdom
facility: University Hospital of North Staffordhsire NHS Trust
state: Staffordshire
city: Birmingham
country: United Kingdom
facility: Birmingham Womens NHS Foundation Trust
state: W Midlands
city: Birmingham
country: United Kingdom
facility: Sandwell & West Birmingham Hospitals NHS Trust
state: West Midlands
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
state: West Midlands
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hosptitals NHS Foundation Trust
city: Stafford
country: United Kingdom
facility: University Hospitals North Midlands NHS Trust
Study officials:
affiliation: University of Nottingham
name: Tim Coleman, Professor
role: STUDY_CHAIR
References:
citation: Naughton F, Prevost AT, Gilbert H, Sutton S. Randomized controlled trial evaluation of a tailored leaflet and SMS text message self-help intervention for pregnant smokers (MiQuit). Nicotine Tob Res. 2012 May;14(5):569-77. doi: 10.1093/ntr/ntr254. Epub 2012 Feb 6.
citation: Cooper S, Foster K, Naughton F, Leonardi-Bee J, Sutton S, Ussher M, Leighton M, Montgomery A, Parrott S, Coleman T. Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:29. doi: 10.1186/s13063-014-0546-4.