Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001050448
Ethics application status
Approved
Date submitted
1/08/2025
Date registered
24/09/2025
Date last updated
6/10/2025
Date data sharing statement initially provided
24/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Which Way? Gulibaa Project: a state-wide, co-designed model of care to support Aboriginal and Torres Strait Islander women to be smoke and vape free
Scientific title
Which Way? Gulibaa Project: Implementing and evaluating a state-wide, co-designed model of care to support Aboriginal and Torres Strait Islander women to be smoke and vape free
Secondary ID [1] 315044 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study which aims to implement and evaluate the program developed as part of a pilot feasibility and acceptability project (ACTRN12623001021662).

Health condition
Health condition(s) or problem(s) studied:
Addiction 338391 0
Tobacco dependance 338392 0
Condition category
Condition code
Mental Health 334700 334700 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Gulibaa Project aims to reduce the prevalence of smoking and vaping among Aboriginal and Torres Strait Islander women by implementing and evaluating an Indigenous led, co-designed group-based smoking and vaping cessation program for healthcare workers within NSW.

Aboriginal and Torres Strait Islander researchers, health workers, and communities were collectively involved in the co-design process to develop the group-based program. This included Yarns between Aboriginal researchers and Aboriginal and Torres Strait Islander women to understand what a group-based cessation program should look like, and how it could best support them to quit. Further non-formal Yarns were conducted with maternal teams to uncover what would be needed to implement cessation support groups within their model of care. A half-day workshop was then held with key community partners including Aboriginal Health Workers, nurses, midwives, and the management team of a maternal health service held at the local Aboriginal Land Council, where they were presented with two key questions: ‘What could a group-based programme to empower Aboriginal and Torres Strait Islander women look like and include?’ and ‘What behaviour change techniques do you think are most important to include in a smoking and vaping programme for Aboriginal and Torres Strait Islander women?’. These were used to inform the program development, with ongoing feedback and oversight by health workers at the maternal service. Training has been developed specifically for this study to assist health workers to implement the co-designed program.

The group-based program: The Which Way? women’s program is a group-based smoking and vaping cessation program. It covers key content including the harms of smoking and vaping, benefits of quitting, overcoming challenges to quitting, and education on nicotine dependence and available cessation supports. The program guides participants on how make a quit plan, explore motivations for quitting and build social supports to help them on their quitting journey. Each session embeds cultural practices and covers practical such as setting a quit date, identifying triggers, using behavioural tools to resist cravings, the importance of healthy lifestyle, relapse prevention, and celebrating successes. The program has been designed to be flexible so that services can deliver the six sessions in a way that is responsive and appropriate to their community and service (i.e., across 6 weeks, condensed across two days, half-day event etc.). The program uses a range of resources to deliver content in an engaging and supportive way, including activities, worksheets, facilitator manuals, and women’s journals. Sessions are structured as follows:
Session 1: Benefits of quitting the smokes and vapes
Session 2: Overcoming the challenges to quitting
Session 3: Support to quit
Session 4: Changing behaviours and developing a quit plan
Session 5: Celebrating success and staying on track
Session 6: Graduation

The acceptability of the program content and implementation was piloted through Yarns and feedback. The program has now been finalised based, and will be implemented and evaluated using the re-aim framework as part of the Gulibaa project.
Intervention code [1] 331646 0
Treatment: Other
Intervention code [2] 331647 0
Behaviour
Comparator / control treatment
No control Group: Hybrid type 1, implementation trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342363 0
Any change in the prevalence of smoking and vaping among Aboriginal and Torres Strait Islander women. Prevalence of smoking and vaping will be assessed as a composite primary outcome, defined as the proportion of participants who report current smoking and/or vaping.
Timepoint [1] 342363 0
6-month post-baseline [group participant endpoint]
Secondary outcome [1] 450526 0
Assess program reach.
Timepoint [1] 450526 0
During first group [group participants], 12-month post implementation [services]
Secondary outcome [2] 450842 0
Assess program effectiveness
Timepoint [2] 450842 0
6-months post baseline [group participant endpoint].
Secondary outcome [3] 450843 0
Assess program adoption
Timepoint [3] 450843 0
6-months post baseline [group participant endpoint].
Secondary outcome [4] 450844 0
Assess program implementation
Timepoint [4] 450844 0
12-months post implementation [services]
Secondary outcome [5] 450845 0
Assess program maintenance
Timepoint [5] 450845 0
12-month post implementation.

Eligibility
Key inclusion criteria
All Aboriginal health services in NSW will be eligible to participate. Staff from participating services will be eligible to participate in the training and facilitate the group-program. Aboriginal and Torres Strait Islander women who are pregnant or of reproductive age, currently smoke or vape at least once per day, and are willing to attend the Which Way group sessions will be eligible to participate.
Minimum age
16 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Aboriginal and Torres Strait Islander people who live outside of NSW. Non-Aboriginal or Torres Strait Islander people. Non-smokers. Males. Age less than 16 or above 49 years. Participants who are currently participating in another smoking cessation trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics using frequencies and percentages will be used to evaluate the pre-post knowledge, attitudes, and behaviours of Health Service Staff. This approach aims to provide a comprehensive overview of the changes in knowledge, attitudes, and behaviours before and after the training intervention. To evaluate smoking cessation outcomes, an intention-to-treat analysis will be used. This means that individuals lost to follow-up will be included in the analysis, assuming that they continue to smoke or vape. A further analysis using logistic regression will be conducted to evaluate the factors associated with smoking cessation. Qualitative data will be analysed by Aboriginal and Torres Strait Islander members of the research team using analysis techniques as responsive to the data collected, such as Template Analysis or Reflexive Thematic Analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319605 0
Government body
Name [1] 319605 0
Medical Research Future Fund (MRFF) Maternal Health and Healthy Lifestyles Grant provided by the Australian Department of Health, Disability and Ageing.
Country [1] 319605 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 322111 0
None
Name [1] 322111 0
Address [1] 322111 0
Country [1] 322111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318170 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 318170 0
Ethics committee country [1] 318170 0
Australia
Date submitted for ethics approval [1] 318170 0
17/09/2024
Approval date [1] 318170 0
31/10/2024
Ethics approval number [1] 318170 0
2328/24
Ethics committee name [2] 318171 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 318171 0
Ethics committee country [2] 318171 0
Australia
Date submitted for ethics approval [2] 318171 0
25/11/2024
Approval date [2] 318171 0
25/11/2024
Ethics approval number [2] 318171 0
R-2024-0082

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

Contacts
Principal investigator
Name 143342 0
Prof Michelle Kennedy
Address 143342 0
IDC Building University of Newcastle, Callaghan, NSW 2308
Country 143342 0
Australia
Phone 143342 0
+61 2 405 53313
Fax 143342 0
Email 143342 0
[email protected]
Contact person for public queries
Name 143343 0
Michelle Kennedy
Address 143343 0
IDC Building University of Newcastle, Callaghan, NSW 2308
Country 143343 0
Australia
Phone 143343 0
+61 2 405 53313
Fax 143343 0
Email 143343 0
[email protected]
Contact person for scientific queries
Name 143344 0
Michelle Kennedy
Address 143344 0
IDC Building University of Newcastle, Callaghan, NSW 2308
Country 143344 0
Australia
Phone 143344 0
+61 2 405 53313
Fax 143344 0
Email 143344 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.