Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy
- Conditions
- Smoking CessationPregnancy Related
- Interventions
- Other: MiQuit text message support programme
- Registration Number
- NCT03231553
- Lead Sponsor
- University of Nottingham
- Brief Summary
The trial aims to determine whether or not MiQuit (text-message support programme) is effective when offered in addition to standard behavioural support for smoking cessation in pregnancy.
- Detailed Description
Smoking in pregnancy is expensive; in the UK in 2010 the annual smoking-attributable maternal and infant health care costs were estimated at up to £87.5 million. In high income countries 13% to 25% of pregnant women smoke and rates are increasing in developing ones. In the UK in 2010 26% of pregnant women smoked with highest rates seen amongst younger, socially disadvantaged women.
However, pregnancy is the life event which most motivates smoking cessation attempts and 50+% of pregnant smokers try stopping, hence smoking cessation support offered in pregnancy is likely to be especially beneficial. Regrettably, in pregnancy, there is only strong efficacy evidence for using either face-to-face or 'self-help' stop smoking support. Although nicotine replacement therapy (NRT) is widely-used by UK pregnant smokers this has at best, borderline efficacy.
Self-help support (SHS) almost doubles the likelihood of smoking cessation in late pregnancy. However SHS programmes which help pregnant smokers to quit were all developed before easily-accessible technologies became widely available.
Text message SHS smoking cessation programmes are highly-acceptable; those trialled with non-pregnant smokers in the US and UK have demonstrated efficacy. Unfortunately, neither programme is appropriate in pregnancy as they make no mention of pregnancy which for most pregnant smokers is the very reason they try quitting; consequently many pregnant smokers would likely find these programmes' advice irrelevant and ignore it.
Funded by CRUK to remedy the lack of acceptable self-help cessation support for pregnant smokers, we developed MiQuit, a text-message, smoking cessation SHS programme for pregnant smokers. MiQuit advice is relevant to pregnancy as it is highly-tailored to gestation. We evaluated MiQuit in two RCTs. The first CRUK-funded trial (n=207) demonstrated acceptability. Subsequently, with NIHR funding we refined MiQuit and tested this in a second RCT which demonstrated the feasibility of recruiting from UK National Health Service (NHS) settings to a multi-centre RCT. Again estimated efficacy was encouraging; in MiQuit and control groups, prolonged abstinence from smoking, validated in late pregnancy was 5.4% and 2.0% respectively.
To efficiently determine whether or not MiQuit works for smoking cessation, we are conducting a third RCT with an almost identical design. The efficacy of the MiQuit system will be assessed by combining the findings, using Trial Sequential Analysis methods, from this trial with the findings from the previous two MiQuit trials. Without requiring an expensive, large RCT this study will tell whether or not MiQuit is efficacious for smoking cessation in pregnancy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1000
- 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
- Owns 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
- Already enrolled in another text service to assist smoking cessation
- Already enrolled in a smoking cessation study
- Having already participated in the study in an earlier pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention MiQuit text message support programme Receive usual NHS antenatal care and any NHS smoking cessation support which they choose to access plus an NHS leaflet giving advice on stopping smoking. Receive MiQuit text message cessation programme.
- Primary Outcome Measures
Name Time Method Self-reported abstinence from smoking 36 weeks gestation Self-reported smoking abstinence from 4 weeks after enrolment until 36 weeks gestation, with no more than 5 cigarettes smoked in total between these time points, as reported and biochemically validated at 36 weeks using a cut-point used in the previous two trials.
- Secondary Outcome Measures
Name Time Method Staff costs Upto 40 weeks after enrolment Overheads and other consumables required to deliver the MiQuit intervention and usual care
Self-reported abstinence from smoking at 4 weeks after randomisation 4 weeks after enrolment 7 day abstinence reported at 4 weeks
Abstinence from smoking at 36 weeks gestation 36 weeks gestation self-reported and biochemically validated 7 day abstinence at 36 weeks gestation
Birth weight At delivery Weight of infant at birth
Health Status - 36 weeks gestation 36 weeks gestation Health status measured by EQ-5D-5L at 36 weeks gestation
Health Status - 4 weeks after randomisation 4 weeks post randomisation Health status measured by EQ-5D-5L at 4 weeks post randomisation
Use of stop-smoking services 36 weeks gestation use of stop-smoking services
Use of NHS care At delivery Use of NHS care
Gestational age At delivery Gestational age at birth
Fetal death At delivery Miscarriage or stillbirth
Maternal death At delivery Death of participant
Health Status - baseline At hospital ante-natal appointment Health status measured by EQ-5D-5L at baseline visit
Maternal hospital admissions At delivery Hospital admission of participant
Infant hospital admission At delivery Hospital admission of infant
Trial Locations
- Locations (17)
Newcastle Upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle, Newcastle Upon Tyne, United Kingdom
East Lancashire Hospitals NHS Trust
🇬🇧Burnley, Lancashire, United Kingdom
United Lincolnshire Hospitals Trust
🇬🇧Multiple Locations, Lincolnshire, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
🇬🇧Derby, Derbyshire, United Kingdom
Sherwood Forest Hospitals NHS Trust
🇬🇧Mansfield, Nottinghamshire, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, Oxfordshire, United Kingdom
North Cumbria University Hospitals NHS Trust
🇬🇧Carlisle, Cumbria, United Kingdom
Birmingham Womens NHS Foundation Trust
🇬🇧Edgbaston, Birmingham, United Kingdom
Plymouth Hospitals NHS Trust
🇬🇧Plymouth, Devon, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Pennine Acute Hospitals NHS Trust
🇬🇧Multiple Locations, Greater Manchester, United Kingdom
Royal Berkshire NHS Foundation Trust
🇬🇧Reading, Berkshire, United Kingdom
Mid Cheshire Hospitals NHS Trust
🇬🇧Crewe, Cheshire, United Kingdom
University Hospitals of North Midlands NHS Trust
🇬🇧Stoke-on-Trent, Staffordshire, United Kingdom
Countess of Chester Hospital NHS Foundation Trust
🇬🇧Chester, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
🇬🇧Sunderland, United Kingdom
Northumbria Healthcare NHS Foundation Trust
🇬🇧North Shields, Tyne And Wear, United Kingdom