Title: BabyBreathe Trial (A randomised controlled trial of a complex intervention to prevent return to smoking postpartum)
Funder: Department of Health and Social Care

Abstract: This study will test a package of support, created by working with women, their partners and NHS staff, to help women who have stopped smoking just before or during pregnancy to stay smoke free following their baby’s birth. The package is called ‘BabyBreathe’. _x000D_ _x000D_ Around a quarter of women in the UK report smoking in the 12 months before becoming pregnant. Over half of these women manage to quit while pregnant but at least half of women start smoking again after their babies are born. This can seriously affect the health of the mother and baby. Smoking is the leading preventable cause of death in adults, causing 80% of deaths from lung cancer and bronchitis. It increases the risk of death from heart disease and other cancers. Babies exposed to ‘second hand smoke’ have higher risks of cot death, breathing and ear problems. Also children of smokers are twice as likely to start smoking. _x000D_ _x000D_ Our team of experts have reviewed published evidence and gathered the views of women who have quit smoking whilst pregnant, their partners and NHS staff to create a package of support. This includes support from a health visitor, tailored online, social and text message support, support to use alternatives to smoking or e-cigarettes as ways to avoid returning to smoking, vouchers (for example a coffee shop voucher) and self rewards to remain smoke free. _x000D_ _x000D_ The BabyBreathe support package is ready for testing in a large study. Women will be identified through their routine midwife or health visitor appointments across four areas of the UK (Norfolk, London, Scotland, the North East). Women eligible and willing to take part will be contacted by the study team who will explain the study in more detail and ask if they would like to join. If they agree, they will then be put into one of two groups, BabyBreathe or usual care, with the same chance of being in either group. _x000D_ _x000D_ We will run the study for 6 months, at which point we will check we are attracting enough women to the study and that they can access the package as intended. If needed, we will expand recruitment to other areas. If the first 6 months go well, we will carry on to recruit 880 women over 15 months. We will collect data from women for up to 12 months after having their baby. We will measure how many women receiving the BabyBreathe support package are smoke free at 12 months following the birth of their baby compared to those not receiving support. We will assess the value for money of the package of support. We will look into which parts of the package are most used, ‘liked’ and appear most effective by detailed interviews with around 40 women and 12 health visitors. This will help us to explain the findings at the end of the trial. We plan to raise awareness of our findings with parents and health care staff by working with Action on Smoking and Health (ASH) and working closely with the Institute of Health Visiting.

Lay abstract: Research question: In women who quit tobacco smoking for or during pregnancy, is the BabyBreathe intervention effective and cost-effective, in comparison with usual care, at reducing return to smoking in real world settings at long-term (12 month) postpartum follow-up?_x000D_ Background: 22% of UK women report smoking in the year before pregnancy. Around half quit smoking during pregnancy, but up to 76% return to smoking within 6 months. There is no routine support preventing relapse. The NHS long-term plan prioritises smoking cessation in pregnancy. This work builds on the success of women quitting in the short-term by preventing relapse to help create more long-term quitters. ‘BabyBreathe’, successfully developed by our team through an MRC PHIND project, is a complex intervention offering a combination of face to face, digital and tailored support to postpartum women. Sustained smoking abstinence has significant health benefits for mothers, minimising long-term smoking harm. Furthermore, maternal smoking is the primary source of infant/child second-hand smoke exposure and a substantial cause of child morbidity and mortality. There is an intergenerational effect: children of smoking mothers are twice as likely to smoke. The total NHS annual cost of smoking continuation, or returning to smoking following pregnancy, is estimated to be up to £64 million for maternal health problems, and inpatient care alone in children, attributable to passive smoking, costs up to £12 million in England._x000D_ Aims and objectives: To undertake a randomised controlled trial (RCT), with internal pilot, comparing BabyBreathe with usual care, assessing long-term smoking abstinence for mothers who have recently given birth and have stopped smoking during pregnancy or during the 12 months prior to pregnancy._x000D_ 1. To run an internal pilot study, with clear stop/go criteria, primarily to test recruitment systems._x000D_ 2. To definitively test real-world effectiveness of BabyBreathe in comparison with usual care, by comparing smoking abstinence at 12 month follow-up between trial groups._x000D_ 3. To undertake a cost effectiveness analysis of Babybreathe in comparison with usual care based on healthcare resource use of mother and infant (from NHS, social care & broader family perspective) and health related quality of life. _x000D_ 4. To undertake an embedded mixed-methods process evaluation to assess delivery, implementation, fidelity and contamination, and to identify mechanisms of action by exploring which intervention components may be particularly effective, for which women, in which contexts._x000D_ Methods: RCT recruiting pregnant women who quit smoking for or during pregnancy across England and Scotland, with an internal pilot, health economic evaluation and process evaluation._x000D_ Timelines: Total duration 39 months: 3m study set up; 15m recruitment; 12-15m follow up (allowing 3m as randomised at 28 weeks gestation); and 6m analysis and dissemination. _x000D_ Anticipated impact and dissemination: we will definitively test BabyBreathe and make recommendations for future implementation, if effective. Results will be disseminated at international conferences and published in leading journals to reach academic experts, disseminated through NHS networks to reach commissioners/managers, and to members of the public via social media and public engagement events, to reach the target population of pregnant and postpartum women and their partners in need of support to stay smoke-free.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;REPRODUCTIVE HEALTH AND CHILDBIRTH;RESPIRATORY;STROKE