Project
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Funded by National Institute for Health Research.
Collaboration with Cambridge University Hospitals NHS, St George's, University of London, University of East Anglia, University of Edinburgh and University of Leicester.
We are acting as the Scottish recruitment hub for a large randomised controlled trial. Compared the effectiveness of an intervention for preventing postpartum return to smoking with usual care
Health Condition(s) or Problem(s) Studied
Healthy postpartum women who have achieved abstinence from tobacco smoking prior to or during pregnancy. The intervention is to prevent postpartum relapse to tobacco smoking.
Intervention(s)
BabyBreathe intervention: This is a complex behavioural intervention involving health visitor support and advice at every routine antenatal and postnatal contact, motivational products (BabyBreathe leaflets and BabyBreathe box), nicotine replacement therapy, electronic carbon monoxide testing, text message support and self-help via the BabyBreathe app and website, offering tailored advice and support for 12 months postpartum.
Control: Usual antenatal and postnatal care as per the NHS maternity care pathway (no routine relapse prevention support).
Key Inclusion and Exclusion Criteria
Study population:
Pregnant women who have quit smoking in the 12 months before or during pregnancy, where smoking abstinence is defined as having stopped smoking for at least 4 weeks prior to recruitment.
Inclusion criteria:
Pregnant women who have stopped smoking completely in the 12 months prior to pregnancy, or at any time during pregnancy.
At 26 weeks gestation or any time up until birth, woman confirms having not smoked a single puff of a cigarette for at least 4 weeks.
Able to read and understand English.
Willing and able to give informed consent for participation in the study.
Expired carbon monoxide (CO) reading less than 4 parts per million (ppm).
Exclusion criteria:
Under the age of 16
Study Type
Randomised controlled trial.
Target Sample Size
880
Primary Outcome(s)
The primary effectiveness outcome is self-reported continuous postpartum smoking abstinence, biochemically validated by CO monitoring at 12 months postpartum, with cut off of less than 8ppm (a reading of 7ppm or less), according to the Russell standard. Adapting the Russell standard, we will grant a period of ‘grace’, allowing up to 5 smoking lapses between the birth of the baby and the 12-month follow-up, before the outcome is counted as relapse.
Key Secondary Outcomes
At 6 months postpartum:
Postpartum self-reported abstinence
Self-reported time to relapse
Self-reported partner smoking status
Relapse predictors
Self-efficacy related to long-term smoking abstinence
Edinburgh postnatal depression scale
Behavioural support use
Nicotine product use
Perceived stress
AUDIT-C
EQ-5D-5L
At 12 months postpartum:
Self-reported time to relapse
Self-reported partner smoking status
Relapse predictors
Self-efficacy related to long-term smoking abstinence
Edinburgh postnatal depression scale
Behavioural support use
Nicotine product use
Perceived stress
AUDIT-C
EQ-5D-5L
Participant resource use
Infant health outcomes
Total award value £234,973.00
Professor of Behavioural Medicine, ISM
Senior Research Fellow, Institute for Social Marketing
Research Fellow 1, Institute for Social Marketing
Research Fellow 1, Institute for Social Marketing
Senior Research Fellow, Institute for Social Marketing
Article
Notley C, Brown TJ, Bauld L, Clark AB, Duneclift S, Gilroy V, Harris T, Hardeman W, Holland R, Howard G, Man M, Naughton F, Smith D, Turner D & Ussher M (2023) BabyBreathe trial: protocol for a randomised controlled trial of a complex intervention to prevent postpartum return to smoking. BMJ Open, 13 (9), Art. No.: e076458. https://doi.org/10.1136/bmjopen-2023-076458