None listed
Conditions
Brief summary
The BUBs Quit individual randomised controlled trial aims to determine the effectiveness of the BQ smoking cessation intervention compared to standard care for pregnant women who smoke with regards to primary and secondary maternal and child health outcomes including smoking cessation at 3 months postpartum. The BQ study will comprise three concurrent phases: impact (phase 1), economic (phase 2) and implementation evaluations (phase 3).
Interventions
The BUBs Quit individual randomised controlled trial aims to determine the effectiveness of the BQ smoking cessation intervention compared to standard care for pregnant women who smoke with regards to primary and secondary maternal and child health outcomes including smoking cessation at 3 months postpartum. The BUBS Quit intervention includes the following components in addition to standard antenatal care delivered in participating centres (highlighted*), 1. Four 1 hour sessions of one-on-one counselling over a 6 week period (in person or via telehealth) with a midwife trained in smoking cessation. Midwives will receive a full day face-to face training by a specialist smoking cessation counsellor who also provide Quitline counselling and they will have ongoing support (monthly 1 hour team meetings). During the sessions midwives will assess nicotine dependence, undertake motivational interviewing, assess readiness to quit, specialist smoking cessation counselling over 4 sessions, support with utilising the technology, develop quit smoking plans, refer to other services, offer nicotine replacement, carry out CO2 measurements. During every session the midwife will go through the list of activities and their personal plan. Adherence to attending the 4 sessions of counselling will be assessed in the follow up assessments which will be carried out by the research assistance. 2. MyQuit Buddy mobile phone App. This smoking cessation mobile health app is developed and managed by the Australian Government Department of Health and Aged Care. Via the app users can: • Set a quit date. • Set goals and add the support they need to achieve them. • Receive a useful tip when they open the app — during the first 30 days. • Nominate danger times and My QuitBuddy sends an alert. • Set a series of scheduled alerts (such as "Congratulations, it’s been two weeks!") to keep them on track. • View daily progress including how much money they’ve saved. • Use a range of distractions to help deal with cravings. • Get reminded of why they decided to quit and to stay focused on their goal with a personalised slideshow. • Read helpful messages from other people who are quitting and leave their own for others to read. • Call the Quitline directly from the app. • Nominate friends or family who they can call in the tough times. Midwives will ask pregnant women what they find useful and valuable in the MyQuit Buddy, and what they did not find helpful. These questions will also be repeated during the assessments by the research assistants. 3. Reinforcement text messages based on World Health Organisation (WHO) handbook. Text messages will be sent to BUBs Quit participants once a week (the day and time of delivery will differ week to week) from when they sign-up to the study until their recorded due date. Participants will be able to request at any time to stop receiving text messages by asking their specialist midwife, emailing the research team, or responding to a text message. Clicksend will be used to send out the text messages. 4. Incentives in the form of e-gift to attend counselling sessions 2 and 4 5. Attendance of the women’s support person if requested 6. Access to ICanQuit website for tips* 7. Smoking cessation intervention options for First Nation Women ISISTA Quit* 8. Smoking cessation intervention options for culturally and linguistically diverse (CALD) women. There will be a translator made available and that material in their own language will also be provided, In addition links to the ICanQuit website pages in their own language will be provided. 9. Safer Baby Bundle, NSW Health Directive for smoking cessation in pregnancy* 10. Referral to Quitline* 11. Referral to other relevant services – drug and alcohol and family services* 12. Nicotine replacement therapy* 13. Carbon monoxide (CO) measurements to motivate quitting or abstinence* *Standard care
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion criteria for eligible pregnant women who: • Smoke cigarettes or smoking cigarettes and vaping (e-cigarettes) • Pregnant women upto 28 weeks gestation at time of study entry • Attending antenatal clinics in maternity services participating in the BUBs Quit study • Have a mechanism for contact (telephone or email) • Provide a signed and dated informed consent form.
Exclusion criteria
The exclusion criteria include ineligible pregnant women who: • Do not smoke cigarettes • Smoke cigarettes but are not wanting to stop smoking i.e. do not want to be part of BUBs Quit smoking cessation intervention trial • Are over 28 weeks gestation • Intend to move away within 6 months • Have severe active mental illness and/or developmental disability precluding informed consent • Have no mechanism for contact (telephone or email) • Have not provided a signed and dated informed consent form.