BACKGROUND: The majority of people who quit smoking in pregnancy relapse postpartum, with most relapse occurring in the first six months after a baby is born. BabyBreathe^TM is a complex intervention offering targeted one-to-one behavioural support in the community, alongside digital, remote and pharmacological support in the postpartum period. In this presentation we report, for the first time, definitive process outcomes from an NIHR funded randomised controlled trial evaluating the BabyBreathe^TM intervention versus usual care.
METHODS: Multi-centre randomised controlled trial (RCT, ISRCTN70307341). The trial recruited people who quit smoking for or during pregnancy across the UK. The BabyBreathe intervention starts in late pregnancy and continues postpartum. The primary outcome is 12 month carbon monoxide (CO) verified sustained smoking abstinence. Process evaluation measures collected assessed engagement, fidelity, contamination, and user experiences of receiving the intervention.
RESULTS: 887 participants were randomised. Mean age was 29 years, and 91% were of white ethnic identity. 45% were co-habiting, with 29% married. 12 month follow up was completed by 751 (85%) people. Of those reporting abstinence, 87% completed biochemical verification. Across groups, biochemically validated smoking abstinence was 55%. 64% self-reported continuous abstinence. Process data demonstrated that face to face support with a community health visitor was delivered with fidelity to the protocol and was experienced by participants as supportive and helpful. Automated text message support was also valued, but other digital aspects of the intervention, including the BabyBreathe^TM website and app, were engaged with relatively infrequently.
CONCLUSIONS: Continued support for smoking cessation during pregnancy is vital to ensure maximum long term health benefits to parents and infants. The BabyBreathe^TM approach shows promise in supporting sustained smoking cessation at 12 months postpartum. Findings suggest implementation should provide targeted and tailored support by healthcare professionals routinely supporting people postpartum, supplemented by automated text message support as low cost long term support.