Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a...

Area of Science:

• Public Health
• Reproductive Health
• Digital Health Interventions

Background:

• Smoking during pregnancy poses significant public health challenges.
• Self-help interventions can aid pregnant women in smoking cessation.
• The effectiveness of SMS text message support for pregnant smokers is not yet fully understood.

Purpose of the Study:

• To estimate key parameters for a definitive trial.
• To test the feasibility of delivering the MiQuit intervention within UK National Health Service settings.
• To provide evidence on the utility of MiQuit for smoking cessation in pregnancy.

Main Methods:

• A multi-centre, parallel group randomized controlled trial (RCT) involving 400 pregnant women across 16 English antenatal care settings.
• Participants randomized 1:1 to receive either a standard National Health Service (NHS) smoking cessation leaflet or the leaflet plus the 12-week MiQuit tailored text message intervention.
• Follow-up via telephone at 4 weeks post-randomization and at 36 weeks gestation.

Main Results:

• The study aims to recruit 400 women to estimate recruitment rates within +/-1% and smoking outcome ascertainment within +/-4%.
• The sample size will allow for estimation of the combined cessation rate at 36 weeks gestation within +/-3%.
• This pilot trial will assess the feasibility and acceptability of the MiQuit intervention and trial procedures.

Conclusions:

• Completion of this pilot trial will yield crucial data for planning a definitive trial.
• The findings will inform the design and execution of a larger study to definitively assess MiQuit's effectiveness.
• This research is essential for advancing smoking cessation strategies in pregnant populations.