Skip to content

Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy

RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03231553
Enrollment
1000
Registered
2017-07-27
Start date
2017-11-30
Completion date
2020-01-15
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related, Smoking Cessation

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.

Interventions

OTHERMiQuit 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.

Sponsors

University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No

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 * 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 another text service to assist smoking cessation * Already enrolled in a smoking cessation study * Having already participated in the study in an earlier pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Self-reported abstinence from smoking36 weeks gestationSelf-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

MeasureTime frameDescription
Abstinence from smoking at 36 weeks gestation36 weeks gestationself-reported and biochemically validated 7 day abstinence at 36 weeks gestation
Use of stop-smoking services36 weeks gestationuse of stop-smoking services
Use of NHS careAt deliveryUse of NHS care
Birth weightAt deliveryWeight of infant at birth
Gestational ageAt deliveryGestational age at birth
Fetal deathAt deliveryMiscarriage or stillbirth
Self-reported abstinence from smoking at 4 weeks after randomisation4 weeks after enrolment7 day abstinence reported at 4 weeks
Health Status - baselineAt hospital ante-natal appointmentHealth status measured by EQ-5D-5L at baseline visit
Health Status - 4 weeks after randomisation4 weeks post randomisationHealth status measured by EQ-5D-5L at 4 weeks post randomisation
Health Status - 36 weeks gestation36 weeks gestationHealth status measured by EQ-5D-5L at 36 weeks gestation
Maternal hospital admissionsAt deliveryHospital admission of participant
Infant hospital admissionAt deliveryHospital admission of infant
Staff costsUpto 40 weeks after enrolmentOverheads and other consumables required to deliver the MiQuit intervention and usual care
Maternal deathAt deliveryDeath of participant

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026