An interventional study of MiQuit text message support programme in Smoking Cessation and Pregnancy Related, sponsored by University of Nottingham. Completed at 17 sites in United Kingdom. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by University of Nottingham · Not applicable, Interventional, and Other
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.
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.
University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: 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.
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.
Self-reported abstinence from smoking
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: 36 weeks gestation
Self-reported abstinence from smoking at 4 weeks after randomisation
7 day abstinence reported at 4 weeks
Time frame: 4 weeks after enrolment
Abstinence from smoking at 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
use of stop-smoking services
Time frame: 36 weeks gestation
Use of NHS care
Use of NHS care
Time frame: At delivery
Birth weight
Weight of infant at birth
Time frame: At delivery
Gestational age
Gestational age at birth
Time frame: At delivery
Fetal death
Miscarriage or stillbirth
Time frame: At delivery
Maternal death
Death of participant
Time frame: At delivery
Health Status - baseline
Health status measured by EQ-5D-5L at baseline visit
Time frame: At hospital ante-natal appointment
Health Status - 4 weeks after randomisation
Health status measured by EQ-5D-5L at 4 weeks post randomisation
Time frame: 4 weeks post randomisation
Health Status - 36 weeks gestation
Health status measured by EQ-5D-5L at 36 weeks gestation
Time frame: 36 weeks gestation
Maternal hospital admissions
Hospital admission of participant
Time frame: At delivery
Infant hospital admission
Hospital admission of infant
Time frame: At delivery
Staff costs
Overheads and other consumables required to deliver the MiQuit intervention and usual care
Time frame: Upto 40 weeks after enrolment
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University of Nottingham