MiQuit text message support programme
OtherMiQuit 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.
NCT Number: NCT03231553
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.
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Notify Me16 year and older
Female
Interventional
Not applicable
Royal Berkshire NHS Foundation Trust, Reading, Berkshire, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 4 weeks after enrolment
7 day abstinence reported at 4 weeks
Time frame: 36 weeks gestation
self-reported and biochemically validated 7 day abstinence at 36 weeks gestation
Time frame: 36 weeks gestation
use of stop-smoking services
Time frame: At delivery
Use of NHS care
Time frame: At delivery
Weight of infant at birth
Time frame: At delivery
Gestational age at birth
Time frame: At delivery
Miscarriage or stillbirth
Time frame: At delivery
Death of participant
Time frame: At hospital ante-natal appointment
Health status measured by EQ-5D-5L at baseline visit
Time frame: 4 weeks post randomisation
Health status measured by EQ-5D-5L at 4 weeks post randomisation
Time frame: 36 weeks gestation
Health status measured by EQ-5D-5L at 36 weeks gestation
Time frame: At delivery
Hospital admission of participant
Time frame: At delivery
Hospital admission of infant
Time frame: Upto 40 weeks after enrolment
Overheads and other consumables required to deliver the MiQuit intervention and usual care
University of Nottingham
Other
RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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