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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smoking Cessation, Pregnancy Related

Intervention / Treatment
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* Other: MiQuit text message support programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 36 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported abstinence from smoking at 4 weeks after randomisation | 7 day abstinence reported at 4 weeks | 4 weeks after enrolment | 
| Abstinence from smoking at 36 weeks gestation | self-reported and biochemically validated 7 day abstinence at 36 weeks gestation | 36 weeks gestation | 
| Use of stop-smoking services | use of stop-smoking services | 36 weeks gestation | 
| Use of NHS care | Use of NHS care | At delivery | 
| Birth weight | Weight of infant at birth | At delivery | 
| Gestational age | Gestational age at birth | At delivery | 
| Fetal death | Miscarriage or stillbirth | At delivery | 
| Maternal death | Death of participant | At delivery | 
| Health Status - baseline | Health status measured by EQ-5D-5L at baseline visit | At hospital ante-natal appointment | 
| Health Status - 4 weeks after randomisation | Health status measured by EQ-5D-5L at 4 weeks post randomisation | 4 weeks post randomisation | 
| Health Status - 36 weeks gestation | Health status measured by EQ-5D-5L at 36 weeks gestation | 36 weeks gestation | 
| Maternal hospital admissions | Hospital admission of participant | At delivery | 
| Infant hospital admission | Hospital admission of infant | At delivery | 
| Staff costs | Overheads and other consumables required to deliver the MiQuit intervention and usual care | Upto 40 weeks after enrolment |