BabyBreathe Trial: Protocol for a Randomised Controlled Trial of a Complex Intervention to Prevent Postpartum Return to Smoking

Overview

Journal BMJ Open

Specialty General Medicine

Date 2023 Sep 4

PMID 37666562

Authors

Caitlin Notley

Tracey J Brown

Linda Bauld

Allan B Clark

Sharon Duneclift

Vicky Gilroy

Tess Harris

Wendy Hardeman

Richard Holland

Gregory Howard

Mei-See Man

Felix Naughton

Dan Smith

David Turner

Michael Ussher

Affiliations

Soon will be listed here.

Abstract

Introduction: Many people quit smoking during pregnancy, but postpartum smoking relapse is common. Maintaining smoking abstinence achieved during pregnancy is key to improving maternal and child health. There are no evidence-based interventions for preventing postpartum smoking relapse. This trial aims to determine whether an intervention to prevent postpartum relapse is effective and cost-effective.

Methods And Analysis: A randomised controlled trial of a complex intervention to prevent postpartum smoking relapse (BabyBreathe), with internal pilot, economic and process evaluations. Participants are adults who are pregnant and who report having quit smoking in the 12 months before, or during pregnancy. Participants are eligible if they read and understand English, and provide informed consent. Following consent and biochemical validation of smoking abstinence, participants are randomised to intervention or usual care/control (no specific relapse prevention support). The BabyBreathe intervention consists of manualised advice from a trained member of the health visiting service, health information leaflets for participants and partners, access to the BabyBreathe website and app. At the time of birth, participants are posted the BabyBreathe box and support is provided by text message for up to 12 months postpartum. Target sample size is 880, recruiting across midwifery services at four hubs in England and Scotland and through remote advertising in England, Scotland, Wales and Northern Ireland. Outcomes are collected at 6 and 12 months. The primary outcome is self-reported sustained smoking abstinence at 12 months, carbon monoxide verified. Secondary outcomes include self-reported abstinence, time to relapse, partner smoking status and quality of life.

Ethics And Dissemination: The trial was approved by the North West Preston Research Ethics committee (21/NW/0017). Dissemination will include publication in peer-reviewed journals, presentation at academic and public conferences including patient and public involvement and to policymakers and practitioners.

Trial Registration Number: ISRCTN70307341.

Citing Articles

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Hammond M, Ashford P, High J, Clark L, Howard G, Jones M Trials. 2024; 25(1):550.

PMID: 39160589 PMC: 11331622. DOI: 10.1186/s13063-024-08386-1.

References

Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2008; 42(2):377-81. PMC: 2700030. DOI: 10.1016/j.jbi.2008.08.010. View

West R, Hajek P, Stead L, Stapleton J . Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction. 2005; 100(3):299-303. DOI: 10.1111/j.1360-0443.2004.00995.x. View

Doll R, Peto R, Boreham J, Sutherland I . Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004; 328(7455):1519. PMC: 437139. DOI: 10.1136/bmj.38142.554479.AE. View

Cohen S, Kamarck T, Mermelstein R . A global measure of perceived stress. J Health Soc Behav. 1983; 24(4):385-96. View

Letourneau A, Sonja B, Mazure C, OMalley S, James D, Colson E . Timing and predictors of postpartum return to smoking in a group of inner-city women: an exploratory pilot study. Birth. 2007; 34(3):245-52. DOI: 10.1111/j.1523-536X.2007.00177.x. View

Jones M, Lewis S, Parrott S, Wormall S, Coleman T . Re-starting smoking in the postpartum period after receiving a smoking cessation intervention: a systematic review. Addiction. 2016; 111(6):981-90. PMC: 6680353. DOI: 10.1111/add.13309. View

Groner J, French G, Ahijevych K, Wewers M . Process evaluation of a nurse-delivered smoking relapse prevention program for new mothers. J Community Health Nurs. 2005; 22(3):157-67. DOI: 10.1207/s15327655jchn2203_3. View

Sims M, Tomkins S, Judge K, Taylor G, Jarvis M, Gilmore A . Trends in and predictors of second-hand smoke exposure indexed by cotinine in children in England from 1996 to 2006. Addiction. 2010; 105(3):543-53. DOI: 10.1111/j.1360-0443.2009.02805.x. View

Chan A, Tetzlaff J, Altman D, Laupacis A, Gotzsche P, Krleza-Jeric K . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; 158(3):200-7. PMC: 5114123. DOI: 10.7326/0003-4819-158-3-201302050-00583. View

10.

Michie S, van Stralen M, West R . The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011; 6:42. PMC: 3096582. DOI: 10.1186/1748-5908-6-42. View

11.

Bailey B . Using expired air carbon monoxide to determine smoking status during pregnancy: preliminary identification of an appropriately sensitive and specific cut-point. Addict Behav. 2013; 38(10):2547-50. DOI: 10.1016/j.addbeh.2013.05.011. View

12.

Livingstone-Banks J, Norris E, Hartmann-Boyce J, West R, Jarvis M, Hajek P . Relapse prevention interventions for smoking cessation. Cochrane Database Syst Rev. 2019; 2:CD003999. PMC: 6372978. DOI: 10.1002/14651858.CD003999.pub5. View

13.

Bush K, Kivlahan D, McDonell M, Fihn S, Bradley K . The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998; 158(16):1789-95. DOI: 10.1001/archinte.158.16.1789. View

14.

Brown T, Hardeman W, Bauld L, Holland R, Maskrey V, Naughton F . A systematic review of behaviour change techniques within interventions to prevent return to smoking postpartum. Addict Behav. 2019; 92:236-243. PMC: 6518963. DOI: 10.1016/j.addbeh.2018.12.031. View

15.

Pollak K, Fish L, Lyna P, Peterson B, Myers E, Gao X . Efficacy of a Nurse-Delivered Intervention to Prevent and Delay Postpartum Return to Smoking: The Quit for Two Trial. Nicotine Tob Res. 2016; 18(10):1960-6. PMC: 5016846. DOI: 10.1093/ntr/ntw108. View

16.

Patnode C, Henderson J, Coppola E, Melnikow J, Durbin S, Thomas R . Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021; 325(3):280-298. DOI: 10.1001/jama.2020.23541. View

17.

Oakley A, Strange V, Bonell C, Allen E, Stephenson J . Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006; 332(7538):413-6. PMC: 1370978. DOI: 10.1136/bmj.332.7538.413. View

18.

Hajek P, Stead L, West R, Jarvis M, Hartmann-Boyce J, Lancaster T . Relapse prevention interventions for smoking cessation. Cochrane Database Syst Rev. 2013; (8):CD003999. DOI: 10.1002/14651858.CD003999.pub4. View

19.

Lumley J, Chamberlain C, Dowswell T, Oliver S, Oakley L, Watson L . Interventions for promoting smoking cessation during pregnancy. Cochrane Database Syst Rev. 2009; (3):CD001055. PMC: 4090746. DOI: 10.1002/14651858.CD001055.pub3. View

20.

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M . Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008; 337:a1655. PMC: 2769032. DOI: 10.1136/bmj.a1655. View