Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000497505
Ethics application status
Approved
Date submitted
13/03/2024
Date registered
23/04/2024
Date last updated
23/04/2024
Date data sharing statement initially provided
23/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
BUBs Quit Study - Specialist midwife helping pregnant women stop smoking
Scientific title
BUBs Quit Study - Randomised controlled trial to determine the effectiveness of a smoking cessation intervention (Clinical Midwife Specialist assisting pregnant women using counselling and embedded technology) compared to standard care for smoking pregnant women
Secondary ID [1] 311611 0
RG213565
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
smoking in pregnancy 333034 0
Condition category
Condition code
Reproductive Health and Childbirth 329717 329717 0 0
Antenatal care
Public Health 329816 329816 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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

Intervention code [1] 328066 0
Treatment: Other
Intervention code [2] 328291 0
Behaviour
Comparator / control treatment
Women in the control group will receive the standard antenatal care which includes mandatory smoking cessation support, dependent on the centres this may include:
1. Access to ICanQuit website for tips
2. Safer Baby Bundle/ISISTA Quit/NSW Health Directive for smoking cessation among pregnant women
3. Referral to Quitline
4. Referral to other relevant services – drug and alcohol and family services
5. Nicotine replacement therapy
6. Carbon monoxide (CO) measurements to motivate quitting or abstinence.
Control group
Active

Outcomes
Primary outcome [1] 337510 0
Point prevalence of abstinence from cigarettes smoked in the past 7 days at 3 months postpartum (6 to 10 months post Initiation of intervention).
Timepoint [1] 337510 0
3 months postpartum (6 to 10 months post Initiation of intervention)
Secondary outcome [1] 432152 0
Point prevalence abstinence from cigarettes in the past 7 days at 2 months from initiation of intervention
Timepoint [1] 432152 0
2 months from initiation of intervention
Secondary outcome [2] 432153 0
Point prevalence abstinence from e-cigarettes smoked at 3 months postpartum (6 to 10 months from initiation of intervention)
Timepoint [2] 432153 0
3 months postpartum (6 to 10 months from initiation of intervention)
Secondary outcome [3] 432154 0
Point prevalence of preterm deliveries (<37 completed weeks gestation) and babies defined as low birth weight (<2.5kg) and small for gestational age (<10th centile for gestation and gender by Australian population centiles) at birth.
Timepoint [3] 432154 0
At birth
Secondary outcome [4] 432155 0
Maternal mental health (depression) at 3 months postpartum (6 to 10 months from initiation of intervention)
Timepoint [4] 432155 0
at 3 months postpartum (6 to 10 months from initiation of intervention)
Secondary outcome [5] 432156 0
Maternal quality of life at 3 months postpartum (6 to 10 months from initiation of intervention)
Timepoint [5] 432156 0
At 3 months postpartum (6 to 10 months from initiation of intervention)
Secondary outcome [6] 434328 0
Maternal quality of life at 3 months postpartum (6 to 10 months from initiation of intervention)
Timepoint [6] 434328 0
(6 to 10 months from initiation of intervention)
Secondary outcome [7] 434329 0
Maternal mental health (anxiety) at 3 months postpartum (6 to 10 months from initiation of intervention)
Timepoint [7] 434329 0
at 3 months postpartum (6 to 10 months from initiation of intervention)

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prior to the start of the recruitment, a randomisation schedule will be generated by an independent statistician from UNSW Stats Central, who will not be involved in any data analysis and will be independent of the study team. The independent statistician will use a software such as R to create a csv file, which will be sent directly (by email) to the study staff in charge of REDCap. The csv file has information such as study ID, stratum for randomisation, and the assignment outcome (i.e., BQ versus standard care).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by using the statistical software. To ensure important baseline variables are evenly distributed across the two study groups, we will conduct stratified randomisation by participants’ First Nations status (First Nations or not First Nations) and study recruitment site (urban or rural).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics (i.e., means with standard deviations for continuous data, median and interquartile range for counts data, and proportions for categorical data) will be employed in this study to describe the distribution of participants' baseline characteristics. Appropriate statistical analysis including t-test, chi-squared test, and non-parametric testing (e.g. Mann-Whitney U) will be conducted to determine the level of significance of the difference in the baseline characteristics between the two arms.

The primary analysis will be Intention-to-treat. Analyses will be conducted to compare the prevalence of smoking between the intervention and standard care groups via generalised linear mixed effect models (e.g., modified Poisson regression) 2 months post initiation of intervention and 3 months postpartum. In this study, we will employ a mixed effect model, specifically a random intercept model, to account for the clustering of participants within maternity services. The proposed model will incorporate group (intervention or control) as fixed categorical effects, an interaction term (group × time), confounding variables (e.g., maternal mental illness, rurality, Aboriginality, education status, BMI, and socio-economic status), and random intercepts for the clustering. The comparison of model fit will be conducted through the utilisation of likelihood ratio tests, as well as the assessment of AIC and BIC statistics. The effect of interest will be the interaction between the group and time variables, which signifies the relative alteration in the logarithmic risks of the outcome for the intervention group in comparison to the control group at different time points (e.g., baseline, 2 months post initiation of intervention and 3 months postpartum), while accounting for confounding factors. A secondary per protocol analysis will assess the impact of the intervention of women that engaged with at least 1 counselling session for all. Primary and secondary outcomes.

The assessment of the maternal mental health status and quality of life in both groups will be conducted using a mixed effects model, which will include the same fixed and random effects as the primary outcome model. The impact of the BQ intervention on baby’s birth weight, gestational age and birth outcomes will be evaluated using the mixed effects linear regression models (mixed effects for potential clustering), controlling for plausible confounders.
The primary approach for addressing missing data will involve the utilisation of multiple imputation, assuming that occurrence of missing at random. The study will report the appropriate effect measures including risk ratio, risk difference, and mean difference along with its corresponding 95% confidence interval. Sensitivity analyses will be performed to assess the robustness of the estimated group effects, such as the use of various approaches to address missing data. Data will be analysed in R 4.3 and SAS software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 315919 0
Government body
Name [1] 315919 0
NHMRC
Country [1] 315919 0
Australia
Funding source category [2] 316181 0
Government body
Name [2] 316181 0
NSW Ministry of Health
Country [2] 316181 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 318070 0
Government body
Name [1] 318070 0
NSW Ministry of Health
Address [1] 318070 0
Country [1] 318070 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314764 0
SESLHD HREC
Ethics committee address [1] 314764 0
Ethics committee country [1] 314764 0
Australia
Date submitted for ethics approval [1] 314764 0
09/01/2024
Approval date [1] 314764 0
12/03/2024
Ethics approval number [1] 314764 0
2023/ETH02729
Ethics committee name [2] 314819 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [2] 314819 0
Ethics committee country [2] 314819 0
Australia
Date submitted for ethics approval [2] 314819 0
20/02/2024
Approval date [2] 314819 0
Ethics approval number [2] 314819 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132654 0
Prof Robyn Richmond
Address 132654 0
UNSW Sydney High St Kensington NSW 2052
Country 132654 0
Australia
Phone 132654 0
+61 2 9065 5091
Fax 132654 0
Email 132654 0
[email protected]
Contact person for public queries
Name 132655 0
Dr Farnaz Sanaei
Address 132655 0
University of New South Wales, level 8, Bright Alliance Building, Avoca St, Randwick NSW 2031
Country 132655 0
Australia
Phone 132655 0
+61 431772599
Fax 132655 0
Email 132655 0
[email protected]
Contact person for scientific queries
Name 132656 0
Dr Farnaz Sanaei
Address 132656 0
UNSW, level 8, Bright Alliance Building, Avoca St, Randwick NSW 2031
Country 132656 0
Australia
Phone 132656 0
+61 431772599
Fax 132656 0
Email 132656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Final decision not yet made about IDP sharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.