Preventing Return to Smoking Postpartum (PReS Study) - Development of a complex intervention to sustain smoking cessation in postpartum women

Lead Research Organisation: University of East Anglia
Department Name: Norwich Medical School

Abstract

This study aims to develop a supportive intervention to help women who have stopped smoking in pregnancy to stay stopped following the birth of a baby.

Approximately a quarter of women in the UK report smoking in the 12 months before pregnancy. Over half of these women manage to quit during pregnancy. However, most women re-start smoking again after their babies are born. This can severely affect the health of the mother, and the baby. Smoking is the leading preventable cause of death in adults, causing 80% of deaths from lung cancer and bronchitis. Babies exposed to 'second-hand smoke' (passive smoking) have higher risks of cot death and suffering from breathing problems and ear infections.

Our team of leading experts in this specific research area will conduct this study. As this study is 'intervention development', it is the first step in developing and initially testing out an approach to helping women to remain smoke free following pregnancy. Although our expert group have been involved in a programme of research work leading up to this point, there are currently no proven effective approaches to helping women to remain smoke-free after childbirth. We will build upon existing evidence by specifically identifying what approaches might best help women to remain smoke free after their babies are born. We will collate and review key findings from scientific studies to identify the best possible approaches and the best timing for support to be provided. We will then gather the views of women, their partners and health professionals in discussion groups to develop and refine elements of an 'intervention' to help women. This is likely to include medication, electronic cigarette use, specialist behavioural support, social support and incentives to remain smoke free. We will also explore ways to deliver the intervention in our discussion groups by finding out whether women prefer online or digital support or to be supported face-to-face, perhaps combining approaches. We will initially test out components of the intervention by working closely with approximately ten individual women who have quit smoking during pregnancy. Finally, we will test the best timing for the intervention, through combining the evidence and our own research findings to determine when the intervention should be delivered and for how long support should continue.

The outcome of our development work will be a defined intervention ready for testing in a larger research trial. We will communicate our ongoing research findings throughout the study via social media (Facebook and Twitter). At the end of the study, we will present our research findings to patients, the public, and professionals delivering care to women. We will use all our professional contacts to ensure our research has an impact on policy and practice. We will also publish our findings in academic journals.

Technical Summary

In the UK 26% of women smoked tobacco in the 12 months before pregnancy (1). Although 54% of smokers quit during pregnancy, 94% of those re-start smoking by 6 months postpartum (5). Continued postpartum abstinence has major health benefits, as many of the risks attributable to smoking, including cancer and heart disease, can be minimised by cessation. Abstinence also reduces children's exposure to second hand smoke, with associated risks including respiratory conditions and cot death (7, 8). In 2015, the UK Royal College of Physicians (9) estimated passive smoking in children had an avoidable annual NHS cost of approximately £23.3 million. This study aims to develop a novel intervention to support women who have stopped smoking in pregnancy to stay stopped in the postpartum period. In phase 1, we will collate evidence from systematic reviews undertaken by our team (15, 25) and other studies to identify suitable intervention components and the underlying theoretical processes of change (behaviour change techniques, BCTs). Promising components are likely to include goal setting, incentives for continued cessation, advice on medication, and social support specifically tailored to postpartum status. The intervention will be developed and refined during phase 2 which involves focus groups with pregnant and post-partum women (smokers and ex-smokers), their partners, healthcare and stop smoking professionals. Focus groups will refine intervention content through discussion, and define procedures for delivery of the intervention, (e.g. brief intervention by a healthcare professional then online, or text message support). In phase 3, we will model the intervention to test it out and further refine it. This modelling phase will confirm the optimal and achievable procedures for delivery, exploring tailored dose and targeting. The output of the study will be the development of a new intervention suitable for further testing in a clinical trial.

Publications

10 25 50
 
Title Babybreathe images 
Description Babybretahe images, logo and identity 
Type Of Art Artwork 
Year Produced 2021 
Impact Printing of images on Babybretahe intreveniton materials 
 
Description ASH factsheet on relapse prevention and health visiting
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
Impact Information and guidance for healhtcare professionals
 
Description ASH factsheet on smoking, pregnancy and fertility
Geographic Reach Europe 
Policy Influence Type Influenced training of practitioners or researchers
 
Description ASH smoking in pregnancy factsheet
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
Impact Widely respected public source of information for patients and helathcare practitioners, for evidence review and gudiance for practice
 
Description BabyBreathe Trial (A randomised controlled trial of a complex intervention to prevent return to smoking postpartum).
Amount £1,510,628 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 03/2020 
End 10/2023
 
Description Cancer Research UK Population Research Committee, Chief Scientists Office and other funders (collaborative award)
Amount £1,413,973 (GBP)
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 08/2017 
End 08/2020
 
Description Associate Editor - Addiction journal 
Organisation Society for the Study of Addiction
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Associate Editor
Collaborator Contribution Member of the journal Editorial team
Impact Associate Editor
Start Year 2020
 
Description Associate Editor - Nicotine and Tobacco Research 
Organisation Society for research on Nicotine and Tobacco
Country United States 
Sector Charity/Non Profit 
PI Contribution Associate Editor
Collaborator Contribution Member of Editorial team
Impact Reviewing papers
Start Year 2018
 
Description Collaboration between Prof Michael Ussher and team at University of East Anglia led by Dr. Caitlin Notley 
Organisation University of East Anglia
Department Population Health and Primary Care
Country United Kingdom 
Sector Hospitals 
PI Contribution So far, contributed to two successful grant applications and several publications
Collaborator Contribution Studies are led by Professor Notley
Impact Several publications and conferences presentations
Start Year 2016
 
Description Collaboration between Professor Michael Ussher and research team at Queen Mary College London, led by Professor Peter Hajek 
Organisation Queen Mary University of London
Department Wolfson Institute of Preventive Medicine
Country United Kingdom 
Sector Public 
PI Contribution So far, Professor Ussher has contributed to successful grant application, writing of protocol, study management and publication of journal article.
Collaborator Contribution Study is led by Professor Hajek.
Impact One publication
Start Year 2016
 
Description Collaboration between Professor Michael Ussher and research team at University of Nottingham, led by Professor Tim Coleman, on a number of active, soon to start and completed studies. 
Organisation University of Nottingham
Department School of Chemistry Nottingham
Country United Kingdom 
Sector Academic/University 
PI Contribution In all of these studies Professor Ussher has been involved from outset in study design, grant applications, recruitment, interpretation of findings and drafting of publications
Collaborator Contribution All the studies have been Led by Professor Tim Coleman
Impact Several publications and conference presentations. Disciplines: epidemiology, statistics, behavioural medicine, health economics, qualitative
Start Year 2010
 
Description Collaboration between Professor Michael Ussher and research team at University of Stirling, led by Professor Niamh Fitzgerald 
Organisation University of Glasgow
Country United Kingdom 
Sector Academic/University 
PI Contribution So far, contributed to successful CRUK grant applications and study management
Collaborator Contribution Work is led by Professor David Tappin
Impact Sinclair L, McFadden M, Tilbrook H, Mitchell A, Keding A, Watson J, Bauld L, Kee F, Torgerson D, Hewitt C, McKell J, Hoddinott P, Harris FM, Uny I, Boyd K, McMeekin N, Ussher M,Tappin T (2020) The Smoking Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a phase III randomised controlled trial. Trials, 21, 183. Disciplines: epidemiology, statistics, behavioural medicine, health economics, qualitative
Start Year 2015
 
Description Leading the UEA Health ad Social Care Partnership Smokefree group 
Organisation University of East Anglia
Country United Kingdom 
Sector Academic/University 
PI Contribution Leading the UEA Health ad Social Care Partnership Smokefree group. This is a collaboration between academia, the key NHS trusts in the region, public health, and relevant charities.
Collaborator Contribution Collaborative meetings to address key issues of local need and collaborate on funding proposals to meet needs
Impact First partnership collaboration meeting convened January 2020
Start Year 2020
 
Description Member of the Advisory Council for 'Action on Smoking and Health' (ASH) 
Organisation Action on Smoking and Health (ASH)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Member of the Advisory Council
Collaborator Contribution Member of the Advisory Council
Impact No outputs
Start Year 2019
 
Description Member of the Tobacco and Alcohol Cochrane review group 
Organisation The Cochrane Collaboration
Department UK Cochrane Centre
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution I was invited to lead the Cochrane financial incentives review, and since invited to collaborate as a team member on the update of the E Cigarette review
Collaborator Contribution Collaborations as part of a review team
Impact Cochrane review of Financial Incentives for Smoking Cessation doi/10.1002/14651858.CD004307
Start Year 2019
 
Description Scientific committee board member (European representative) - Society for Research on Nicotine and Tobacco 
Organisation Society for Research on Nicotine and Tobacco (SRNT) Europe
Country Mexico 
Sector Academic/University 
PI Contribution Board member
Collaborator Contribution Board member
Impact Board member
Start Year 2019
 
Description Smoking in Pregnancy Challenge Group 
Organisation Action on Smoking and Health (ASH)
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution The studies conducted by Professor Bauld and her colleagues that focus on Smoking in Pregnancy have directly contributed to the success of the multi-agency Smoking in Pregnancy Challenge Group, coordinated by ASH and including over 20 other organisations including PHE, Royal College of Midwives, Royal College of Nursing, SANDS and other baby charities. Professor Bauld is co-chair of the Challenge group along with Clea Harmer, chief executive of SANDS
Collaborator Contribution ASH coordinates the partnership. The many other members (see URL) support the partnership in a variety of ways including the challenge group's reports
Impact Annual reports from the partnership which can be found on the Challenge Group's website. Also practical resources on the maternal health workforce, carbon monoxide breath testing and e-cigarette use in pregnancy
Start Year 2013
 
Description Smoking in Pregnancy Challenge Group 
Organisation Public Health England
Country United Kingdom 
Sector Public 
PI Contribution The studies conducted by Professor Bauld and her colleagues that focus on Smoking in Pregnancy have directly contributed to the success of the multi-agency Smoking in Pregnancy Challenge Group, coordinated by ASH and including over 20 other organisations including PHE, Royal College of Midwives, Royal College of Nursing, SANDS and other baby charities. Professor Bauld is co-chair of the Challenge group along with Clea Harmer, chief executive of SANDS
Collaborator Contribution ASH coordinates the partnership. The many other members (see URL) support the partnership in a variety of ways including the challenge group's reports
Impact Annual reports from the partnership which can be found on the Challenge Group's website. Also practical resources on the maternal health workforce, carbon monoxide breath testing and e-cigarette use in pregnancy
Start Year 2013
 
Title Babybreathe intervention 
Description We developed the Babybreathe intervention, including a website, app and patient facing recources. The package of support and the name are trademarked 
IP Reference  
Protection Trade Mark
Year Protection Granted 2021
Licensed Yes
Impact Use of the intervention with a randomsied controlled trial (ongoing)
 
Title Babybreathe website and app 
Description Babybretahe website and Babybreathe intervention app 
Type Of Technology Webtool/Application 
Year Produced 2021 
Impact Use of website and app within interveniton, now tested within a randomised controlled trial 
 
Description Activity stall on tobacco harm reduction at the Norwich Science Festival 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Part of Norwich Science festival
Year(s) Of Engagement Activity 2019
 
Description Articles in local newspapers following PReS study press release 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Media (as a channel to the public)
Results and Impact We released a press release about the study and to improve recruitment rates. This generated some interest and was published in four regional/local newspapers. we recruited some research participants following this press release
Year(s) Of Engagement Activity 2017
URL http://www.edp24.co.uk/news/health/post-pregnancy-smoking-study-needs-norfolk-volunteers-1-5226467
 
Description Dr Caitlin Notley - invited to talk at the regional Smoking in pregnancy away day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Invited to preesnt emergent research findings at the Smoking in pregnancy regional meeting
Year(s) Of Engagement Activity 2018
 
Description Dr Caitlin Notley - member of Norfolk and Suffolk smoking in pregnancy working group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Invited as a member of the smoking in pregnancy action / working group
Year(s) Of Engagement Activity 2018
 
Description Dr Caitlin Notley: Society for Research on Nicotine and Tobacco European representative board member 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact In January 2018 Dr Notley was nominated as the Society for Research on Nicotine and Tobacco member delegate representing Europe. This is a prestigious role for which she will hold a three year term of office.
Year(s) Of Engagement Activity 2018
URL http://www.srnt.org/
 
Description Dr Notley: member of smokefree policy implementation working group at Norfolk and Suffolk Mental Health Foundation Trust 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Dr Notley is a member of the NSFT Nicotine Management group, advising on the forthcoming smoke free policy to be implemented across the trust, with a proactive stance on vaping as a substitute nicotine replacement option.
Year(s) Of Engagement Activity 2017,2018
 
Description Electronic cigarettes in pregnancy: what do we know? Society for Research on Nicotine and Tobacco, Florence, Italy, 11th March 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Parallel paper presentation at the annual meeting of the professional (academic) organisation (SRNT Europe) where I currently hold the role of President
Year(s) Of Engagement Activity 2017
 
Description Interview for Study for Society of Addiction's 'Women in Addictions Science' project 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact In November 2019 the Society for the Study of Addiction launched their 'women in addictions science' project. Dr Notley was interviewed for this as a 'future leader'. The project was launched at the 2018 SSA annual symposium, Newcastle. The project website includes a film and interview with Dr Notley.
Year(s) Of Engagement Activity 2018
 
Description Invited talk to present latest research on incentives and relapse prevention for smoking cessation during pregnancy at the Pregnancy Challenge Group. 11-2019 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Invited talk to present latest research on incentives and relapse prevention for smoking cessation during pregnancy at the Pregnancy Challenge Group. 11-2019
Year(s) Of Engagement Activity 2019
 
Description PReS Study website 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Study participants or study members
Results and Impact Project website with links to outputs and study updates. Liunk to twitter feed with relevant research related links and resources
Year(s) Of Engagement Activity 2017,2018
URL https://www.uea.ac.uk/medicine/research/addiction/pres-study
 
Description PReS study- Development of an evidence based complex intervention for maintaining positive behaviour change. Poster presentation. Society for the Study of Addiction, Newcastle-Upon-Tyne, UK, 8th-9th November, 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Oral and poster presentation at Society for the Study of Addiction annual meeting
Year(s) Of Engagement Activity 2018
 
Description Presentation at Pregnancy Challenge group meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Invited to present emergent research findings to varied audience at the Pregnancy Challenge group annual meeting
Year(s) Of Engagement Activity 2018
 
Description Presentation of emergent findings for the PReS study, Smoking in Pregnancy Leads Meeting, Cambridge, UK, 8th Feb 2018 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Invitation to present emergent findings to the Eastern Smoking in Pregnancy Leads meeting
Year(s) Of Engagement Activity 2018
 
Description Preventing Return to Smoking Postpartum (PReS Study): an evidence based complex intervention for relapse prevention. SRNT, 20-23rd February, 2019 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Poster presentation at Society for Research on Nicotine and Tobacco annual meeting
Year(s) Of Engagement Activity 2019
 
Description Preventing return to smoking postpartum (PReS study). Symposium abstract. SRNT-E, Munich, 6th-8th September 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Symposium abstract presented at SRNT-E annual meeting
Year(s) Of Engagement Activity 2018
 
Description Public lecture at Norwich Science Festival October 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Dr Notley gave a public lecture at the Norwich Science Festival drawing on the findings from the study.
Year(s) Of Engagement Activity 2018
 
Description Re-configuring identity postpartum and sustained abstinence or relapse to tobacco smoking. SRNT, San Francisco, 20-23rd February, 2019 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Poster presentation at Society for Research on Nicotine and Tobacco annual meeting
Year(s) Of Engagement Activity 2019
 
Description Science committee chair - Global Forum on Nicotoine conference 2018 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact As a result of working in the field of e cigarettes, for 2018 Dr Notley been asked to chair the Science track for the Global Forum on Nicotine conference. This involves leading a committee and taking lead responsibility for inviting guest speakers, designing the programme of scientific papers, assessing abstracts and choosing invited presenters.
Year(s) Of Engagement Activity 2018
URL https://gfn.net.co/welcome
 
Description Smoking in pregnancy: what next? Plenary presentation at Scottish Smoking Cessation Conference, Edinburgh 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Plenary presentation at an annual conference on smoking cessation convened by Health Scotland and attended by a range of delegates working in relevant organisations across Scotland
Year(s) Of Engagement Activity 2017
 
Description Stand at Norwich Science Festival October 2018 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Dr Notley hosted a smoking cessation stand, working with Smokefree Norfolk at the 2018 Norwich Science Festival. This included hands on displays and interactions with members of the public on ongoing research. As well as distributing our 'staying switched leaflets' we produced other public facing materials, such as a lanyard quiz about the health effects of smoking.
Year(s) Of Engagement Activity 2018
 
Description Talk on smoking cessation in pregnancy 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Invited talk to the Yorkshire and Humber Smoke-free pregnancy seminar
Year(s) Of Engagement Activity 2022
 
Description UEA Inaugural Professorial lectures - Harm reduction: Minimising the consequences of addictive behaviour. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Inaugural professorial lecture
Year(s) Of Engagement Activity 2022
 
Description webinar on Health Visitors and relapse prevention, hosted by ASH 25-4-19 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact webinar on Health Visitors and relapse prevention, hosted by ASH 25-4-19
Year(s) Of Engagement Activity 2019