Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000604303
Ethics application status
Approved
Date submitted
17/11/2008
Date registered
3/12/2008
Date last updated
8/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Aboriginal Smoking Cessation: Randomised trial of support strategies in Aboriginal health services. Be our Ally Beat Smoking (BOABS) Study
Scientific title
A randomised controlled trial in Indigenous Australian clients of primary health care services of a twelve month intensive multidimensional smoking cessation intervention with a primary end point of sustained cessation at twelve months from the beginning of the intervention.
Secondary ID [1] 283548 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BOABS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 3989 0
Condition category
Condition code
Public Health 4188 4188 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One year intensive primary healthcare-based, Aboriginal researcher-led multidimensional smoking cessation program – individualised smoking cessation plan; regular personal contact & counselling (12-14 individual sessions); monthly group sessions; and support to assist access to existing smoking cessation, health and other services.
Intervention code [1] 3711 0
Other interventions
Intervention code [2] 3712 0
Behaviour
Comparator / control treatment
Regional best practice clinic based smoking cessation program following Kimberley Smoking Cessation Protocol
Control group
Active

Outcomes
Primary outcome [1] 5077 0
Proportion of participants who are not smoking tobacco as determined by urinary cotinine level
Timepoint [1] 5077 0
12 months after randomisation
Primary outcome [2] 5146 0
Proportion of participants who are not smoking tobacco as determined by self-report
Timepoint [2] 5146 0
6 months after randomisation
12 months after randomisation
Secondary outcome [1] 8530 0
Proportion of participants who report 20% or greater reduction in the number of cigarettes smoked each week
Timepoint [1] 8530 0
6 & 12 months after randomisation
Secondary outcome [2] 8664 0
Proportion of participants reporting excellent or very good health using a self-reported health questionnaire
Timepoint [2] 8664 0
6 & 12 months after randomisation

Eligibility
Key inclusion criteria
Self-reported current smoker
Aboriginal and/or Torres Strait Islander
A regular client of the health service
Considering quitting smoking soon / within the next 30 days (READY stage)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent
A health condition that would prevent them from completing the trial
Unlikely to be available for follow up at 12 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
People attending the primary care services who meet the eligibility criteria will be provided with information about the trial and if they give informed consent to participate will have the initial questionnaire completed. The Research Asssistant (RA) at the trial site will then contact the holder of the allocation schedule based at the central administration site who will then allocate to intervention or control group based on the randomisation list (see below).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation table created by computer software (i.e., computerised sequence generation) with block stratification by study site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/12/2008
Actual
8/01/2009
Date of last participant enrolment
Anticipated
Actual
4/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1304 0
6728

Funding & Sponsors
Funding source category [1] 4235 0
Government body
Name [1] 4235 0
National Health and Medical Research Council (NHMRC)
Country [1] 4235 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 3752 0
University
Name [1] 3752 0
James Cook Universtiy
Address [1] 3752 0
School of Medicine & Dentistry, Cairns Base Hospital, PO Box 902, Cairns QLD 4870
Country [1] 3752 0
Australia
Secondary sponsor category [2] 3809 0
Commercial sector/Industry
Name [2] 3809 0
Kimberley Aboriginal Medical Services Council
Address [2] 3809 0
PO Box 1377
Broome
WA 6725
Country [2] 3809 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6233 0
Human Research and Ethics Committee, University of WA
Ethics committee address [1] 6233 0
Ethics committee country [1] 6233 0
Australia
Date submitted for ethics approval [1] 6233 0
Approval date [1] 6233 0
22/10/2008
Ethics approval number [1] 6233 0
RA/4/1/2175
Ethics committee name [2] 6288 0
Western Australian Aboriginal Health Information and Ethics Committee
Ethics committee address [2] 6288 0
Ethics committee country [2] 6288 0
Australia
Date submitted for ethics approval [2] 6288 0
Approval date [2] 6288 0
22/10/2007
Ethics approval number [2] 6288 0
169-05-07

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

Contacts
Principal investigator
Name 29138 0
A/Prof Julia Marley
Address 29138 0
The Rural Clinical School of Western Australia, The University of Western Australia, &
Kimberley Aboriginal Medical Services Council Inc
PO Box 1377
Broome WA 6725
Country 29138 0
Australia
Phone 29138 0
+61 8 9194 3200
Fax 29138 0
Email 29138 0
[email protected]
Contact person for public queries
Name 12295 0
Julia Marley
Address 12295 0
PO Box 1377
Broome
WA 6725
Country 12295 0
Australia
Phone 12295 0
+61 8 9194 3200
Fax 12295 0
+61 8 91922500
Email 12295 0
[email protected]
Contact person for scientific queries
Name 3223 0
Julia Marley
Address 3223 0
PO Box 1377
Broome
WA 6725
Country 3223 0
Australia
Phone 3223 0
+61 8 9194 3200
Fax 3223 0
+61 8 91922500
Email 3223 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe protocol for the Be Our Ally Beat Smoking (BOABS) study, a randomised controlled trial of an intensive smoking cessation intervention in a remote Aboriginal Australian health care setting2012https://doi.org/10.1186/1471-2458-12-232
N.B. These documents automatically identified may not have been verified by the study sponsor.