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Trial registered on ANZCTR


Registration number
ACTRN12609000224224
Ethics application status
Approved
Date submitted
24/04/2009
Date registered
4/05/2009
Date last updated
18/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing excessive alcohol consumption in community sports clubs: efficacy of a comprehensive
accreditation intervention
Scientific title
A cluster randomised controlled trial of an alcohol management accreditation program, aimed at reducing harmful levels of alcohol consumption in community sports clubs
Secondary ID [1] 262734 0
-
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prevention and reduction of risky alcohol consumption 4599 0
Condition category
Condition code
Public Health 4895 4895 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be provided free of charge to each club in the intervention group. Strategies focus on harm-reduction strategies such as: an appropriate liquor license; training in the responsible service of alcohol; provision of low and non-alcoholic beverage alternatives; provision of food and safe transport strategies; modification of fundraising, end-of-season events and functions; and the implementation and monitoring of alcohol and business management policies. It is expected that the intervention will affect player and non-player club membership. To facilitate adoption of the above strategies into routine business practice, each club will receive responsible service and club management training, independent program performance audits and feedback, financial incentives to support the uptake of the program each season, resources and social marketing support. Clubs will also receive an accreditation manual and resources. In addition, participating clubs will have access to project officer support each season. The project officer will operate in a capacity building manner, assisting clubs progress through the accreditation levels, provide advice, conduct/facilitate training for bar staff and officials, prepare materials, promote the program in the local area, and provide feedback regarding club practices and progress through the accreditation criteria. The intervention will be delivered over two and a half successive sports seasons. As the targeted sports (rugby league, rugby union, soccer and AFL football) are ‘winter’ sports, many of the clubs are relatively dormant during the summer months. As a consequence, delivery of the intervention will be limited to the approximate 6 month winter sport season in each of the two years and a 3 month period in the third year. Across the first two years of intervention clubs will be supported to implement practice changes and environmental modification and in the third year of intervention they will be support to maintain these changes and to implement policies.
Intervention code [1] 4363 0
Prevention
Comparator / control treatment
Clubs allocated to the control group will receive generic printed health behaviour information. This will comprise of a printed material describing healthy lifestyle behaviours. It will be sent to the club at the start of the intervention only, and clubs will be asked to offer the material to club members. Control clubs will not receive generic health behaviour information for the rest of the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 5786 0
Reduction in risky alcohol consumption at the club. Baseline measurements are taken the season before the intervention begins (winter 2009), and follow-up data is collected after two years of intervention (end of 2011) and following two and a half years of intervention delivery (mid 2012). All data will be collected via Computer Assisted Telephone Interviews (CATI). Risky drinking will be assessed by the Graduated Frequency Index, a standard Australian instrument used to assess the amount and frequency of consumption in the last 3 months and a 7-day alcohol consumption diary.
Timepoint [1] 5786 0
The data collection and intervention will follow the following timeline: baseline data collection will occur in Season 1 (2009), the first part of the intervention will occur in the winter sports seasons in 2010 and 2011; follow-up data collection will occur with the cohort that participated in the 2009 baseline survey at the end of 2011; the second part of the intervention will occur in the first 3 months of the 2012 season; and follow-up data collection will occur in mid 2012 with a second cross section of club members.
Secondary outcome [1] 241765 0
Responsible service of alcohol practices and management policies of clubs. This data will be collected via CATI with club committee members who have access to club records and club members.
Timepoint [1] 241765 0
The data collection and intervention will follow the following timeline: baseline data collection will occur in Season 1 (2009), the first part of the intervention will occur in the winter sports seasons in 2010 and 2011; follow-up data collection will occur at the end of 2011; the second part of the intervention will occur in the first 3 months of the 2012 season; and follow-up data collection will occur in mid 2012.
Secondary outcome [2] 241766 0
Number of club members and players. This data will be collected via Computer Assisted Telephone Interview (CATI) with club commitee members who have access to club membership and club player records.
Timepoint [2] 241766 0
The data collection and intervention will follow the following timeline: baseline data collection will occur in Season 1 (2009), the first part of the intervention will occur in the winter sports seasons in 2010 and 2011; follow-up data collection will occur at the end of 2011; the second part of the intervention will occur in the first 3 months of the 2012 season; and follow-up data collection will occur in mid 2012.
Secondary outcome [3] 241768 0
Club member and player food purchasing behaviour at club venues. This data will be collected via Computer Assisted Telephone Interview (CATI) with club members records.
Timepoint [3] 241768 0
The data collection and intervention will follow the following timeline: baseline data collection will occur in Season 1 (2009), the first part of the intervention will occur in the winter sports seasons in 2010 and 2011; follow-up data collection will occur at the end of 2011; the second part of the intervention will occur in the first 3 months of the 2012 season; and follow-up data collection will occur in mid 2012.
Secondary outcome [4] 241769 0
Availability of foods and beverages sold through club outlets. This data will be collected via Computer Assisted Telephone Interview (CATI) with club members
Timepoint [4] 241769 0
The data collection and intervention will follow the following timeline: baseline data collection will occur in Season 1 (2009), the first part of the intervention will occur in the winter sports seasons in 2010 and 2011; follow-up data collection will occur at the end of 2011; the second part of the intervention will occur in the first 3 months of the 2012 season; and follow-up data collection will occur in mid 2012.
Secondary outcome [5] 241770 0
Promotion and pricing of foods and beverages sold through club outlets. This data will be collected via Computer Assisted Telephone Interview (CATI) with club commitee members who have access to club canteen/kiosk/bar records
Timepoint [5] 241770 0
The data collection and intervention will follow the following timeline: baseline data collection will occur in Season 1 (2009), the first part of the intervention will occur in the winter sports seasons in 2010 and 2011; follow-up data collection will occur at the end of 2011; the second part of the intervention will occur in the first 3 months of the 2012 season; and follow-up data collection will occur in mid 2012.
Secondary outcome [6] 241771 0
Overall club revenue. This data will be collected via Computer Assisted Telephone Interview (CATI) with club commitee members who have access to financial ecords
Timepoint [6] 241771 0
The data collection and intervention will follow the following timeline: baseline data collection will occur in Season 1 (2009), the first part of the intervention will occur in the winter sports seasons in 2010 and 2011; follow-up data collection will occur at the end of 2011; the second part of the intervention will occur in the first 3 months of the 2012 season; and follow-up data collection will occur in mid 2012.
Secondary outcome [7] 241776 0
Social capital. This data will be collected via the Computer Assisted Telephone Interview (CATI) with club members
Timepoint [7] 241776 0
The data collection and intervention will follow the following timeline: baseline data collection will occur in Season 1 (2009), the first part of the intervention will occur in the winter sports seasons in 2010 and 2011; follow-up data collection will occur at the end of 2011; the second part of the intervention will occur in the first 3 months of the 2012 season; and follow-up data collection will occur in mid 2012.
Secondary outcome [8] 301786 0
Overall risky alcohol consumption by club members (not specific to drinking at the club). All data will be collected via Computer Assisted Telephone Interviews (CATI). Risky drinking will be assessed by the Alcohol Use Disorders Identification Test (AUDIT).
Timepoint [8] 301786 0
Baseline measurements are taken the season before the intervention begins (winter 2009), and follow-up data is collected after two years of intervention (end of 2011) and following two and a half years of intervention delivery (mid 2012).

Eligibility
Key inclusion criteria
Community sports club with 40 members or more, sells alcohol, is either a rugby league, rugby union, AFL football, or soccer club
Minimum age
18 Years
Maximum age
N/A
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not a community sports club; club has less than 40 members; does not sell alcohol; club is not a rugby league, rugby union, AFL football or soccer club; club only has junior teams; club is participating in an intervention targeting alcohol consumption.

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)
All clubs in the study area will be identified through club lists provided by sporting associations and local councils and contacted via telephone to assess eligibility by a research assistant.

Eligible clubs will be sent a study information letter before being telephoned and invited to participate in the study by a research assistant.

Participating clubs will be randomly assigned to intervention or control conditions by a research statistician.

Randomly selected members of participating clubs will be sent study information letters by a club representative before being telephoned and invited to participate in the study by a research assistant blind to group allocation. Thus, allocation will be by concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation table created by a computer software program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Random allocation of clubs was stratified by football code and geographic area.
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4784 0
Government body
Name [1] 4784 0
Australian Research Council
Address [1] 4784 0
1st Floor, 8 Brindabella Circuit
Brindabella Business Park
CANBERRA AIRPORT ACT 2609
Country [1] 4784 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Drug Foundation
Address
409 King Street
West Melbourne, 3003
Country
Australia
Secondary sponsor category [1] 4319 0
University
Name [1] 4319 0
University of Newcastle
Address [1] 4319 0
Cnr King and Auckland Streets
Newcastle NSW 2300
Country [1] 4319 0
Australia
Secondary sponsor category [2] 4320 0
Government body
Name [2] 4320 0
Hunter New England Population Health
Address [2] 4320 0
Booth Building, Wallsend Health Services
Longworth Ave
WALLSEND NSW 2287
Country [2] 4320 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6833 0
Human Research Ethics Committee, University of Newcastle
Ethics committee address [1] 6833 0
Research Services
Research Office
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 6833 0
Date submitted for ethics approval [1] 6833 0
12/02/2009
Approval date [1] 6833 0
24/03/2009
Ethics approval number [1] 6833 0
H-2008-0432

Summary
Brief summary
It is hypothesised that clubs participating in the accrediation program will have a signficant reduction in harmful alcohol-related behaviour over the intervention period. In contrast, it is expected that clubs not participating in the intervention will not have a significant reduction in harmful alcohol-related behaviour over the same period of time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29490 0
A/Prof A/Prof John Wiggers
Address 29490 0
The University of Newcastle
c/- Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2299
Australia
Country 29490 0
Australia
Phone 29490 0
+61 2 49246247
Fax 29490 0
Email 29490 0
john.wiggers@hnehealth.nsw.gov.au
Contact person for public queries
Name 12737 0
A/Prof Associate Professor John Wiggers
Address 12737 0
Student Services Building
University of Newcastle
University Drive
Callaghan NSW 2308
Country 12737 0
Australia
Phone 12737 0
+61 2 4921 5000
Fax 12737 0
+61 2 4921 2020
Email 12737 0
John.Wiggers@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 3665 0
A/Prof Associate Professor John Wiggers
Address 3665 0
Student Services Building
University of Newcastle
University Drive
Callaghan NSW 2308
Country 3665 0
Australia
Phone 3665 0
+ 61 2 4924 6247
Fax 3665 0
Email 3665 0
John.Wiggers@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary