RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Nottingham
- Enrollment
- 1,000
- Locations
- 34
- Primary Endpoint
- Self-reported abstinence from smoking
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Self-reported abstinence from smoking
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.
Secondary Outcomes
- Staff costs(Upto 40 weeks after enrolment)
- Self-reported abstinence from smoking at 4 weeks after randomisation(4 weeks after enrolment)
- Abstinence from smoking at 36 weeks gestation(36 weeks gestation)
- Birth weight(At delivery)
- Health Status - 36 weeks gestation(36 weeks gestation)
- Health Status - 4 weeks after randomisation(4 weeks post randomisation)
- Use of stop-smoking services(36 weeks gestation)
- Use of NHS care(At delivery)
- Gestational age(At delivery)
- Fetal death(At delivery)
- Maternal death(At delivery)
- Health Status - baseline(At hospital ante-natal appointment)
- Maternal hospital admissions(At delivery)
- Infant hospital admission(At delivery)