Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy
NCT ID: NCT03231553
Last Updated: 2020-04-21
Study Results
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Basic Information
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COMPLETED
NA
1000 participants
INTERVENTIONAL
2017-11-30
2020-01-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Intervention
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.
MiQuit text message support programme
MiQuit is an automated, responsive text message support programme lasting 12 weeks which sends texts containing self-help smoking cessation support and advice to participants mobile phones.
Control
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.
No interventions assigned to this group
Interventions
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MiQuit text message support programme
MiQuit is an automated, responsive text message support programme lasting 12 weeks which sends texts containing self-help smoking cessation support and advice to participants mobile phones.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Already enrolled in a smoking cessation study
* Having already participated in the study in an earlier pregnancy
16 Years
FEMALE
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Tim Coleman
Role: STUDY_DIRECTOR
University of Nottingham
Locations
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Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom
Birmingham Womens NHS Foundation Trust
Edgbaston, Birmingham, United Kingdom
Mid Cheshire Hospitals NHS Trust
Crewe, Cheshire, United Kingdom
North Cumbria University Hospitals NHS Trust
Carlisle, Cumbria, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, Derbyshire, United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, Devon, United Kingdom
Pennine Acute Hospitals NHS Trust
Multiple Locations, Greater Manchester, United Kingdom
East Lancashire Hospitals NHS Trust
Burnley, Lancashire, United Kingdom
United Lincolnshire Hospitals Trust
Multiple Locations, Lincolnshire, United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, Newcastle Upon Tyne, United Kingdom
Sherwood Forest Hospitals NHS Trust
Mansfield, Nottinghamshire, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, Tyne and Wear, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Countess of Chester Hospital NHS Foundation Trust
Chester, , United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland, , United Kingdom
Countries
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References
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Coleman T, Clark M, Welch C, Whitemore R, Leonardi-Bee J, Cooper S, Hewitt C, Jones M, Sutton S, Watson J, Daykin K, Ussher M, Parrott S, Naughton F. Effectiveness of offering tailored text message, self-help smoking cessation support to pregnant women who want information on stopping smoking: MiQuit3 randomised controlled trial and meta-analysis. Addiction. 2022 Apr;117(4):1079-1094. doi: 10.1111/add.15715. Epub 2021 Nov 5.
Whitemore R, Leonardi-Bee J, Naughton F, Sutton S, Cooper S, Parrott S, Hewitt C, Clark M, Ussher M, Jones M, Torgerson D, Coleman T. Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis. Trials. 2019 May 22;20(1):280. doi: 10.1186/s13063-019-3341-4.
Other Identifiers
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17065
Identifier Type: -
Identifier Source: org_study_id
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