Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000746639
Ethics application status
Approved
Date submitted
4/07/2014
Date registered
14/07/2014
Date last updated
24/04/2019
Date data sharing statement initially provided
24/04/2019
Date results information initially provided
24/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of an intervention to maintain alcohol management practices in community sporting clubs
Scientific title
Assessing the effectiveness of a web-based intervention in maintaining best practices alcohol management practices in community sporting clubs compared to a usual care intervention: a randomised trial
Secondary ID [1] 284593 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excessive alcohol consumption 291890 0
Condition category
Condition code
Public Health 292234 292234 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a web-based sustainability support system for maintaining best-practice alcohol management practices.

The web-based intervention will include the following evidence-based strategies:
1. Club champion – Telephone contacts at the start of each season will be conducted between research staff and club representatives to identify an individual in the club with positional or personal authority (preferably a member of the club executive committee) who has the appropriate skills and experience and is motivated to act as the project champion. Club champions will primarily engage with the web-based program on behalf of the club and co-ordinate activity within the club to ensure the sustainability of the clubs alcohol management practices. The program will guide the champion to complete key project sustainability activities each year.
2. Executive support – the web-based program will encourage the club representative to re-affirm the clubs
commitment to sustaining the clubs’ alcohol management practices via endorsement of an alcohol management policy and communicating club expectations regarding alcohol management to members.
3. Training – The web-based program will provide a series of on-line training modules. The number and length of training modules will be determined following pilot testing.
4. Tools and resources – The web-based intervention will provide printable instructional materials, sample policies, planning templates, and self- assessment forms to allow self-monitoring of maintenance of alcohol management practices.
5. Systems and prompts – The web-based program will utilise electronic reminders (e.g. text messaging and emails) to prompt key sustainability task completion each year.
6. Communication and marketing- The project champion will be encouraged via the web-based system to send electronic newsletters to club members incorporating information regarding responsible alcohol practices at the club.

The intervention will be implemented for two years between baseline data collection (and randomisation) and post-intervention data collection.

Intervention adherence will be monitored through reports generated through the web-based software, which will monitor training completion, etc.
Intervention code [1] 289367 0
Behaviour
Comparator / control treatment
Control group clubs will not receive access to the web-based program or any additional or alternative support during the trial period. These clubs will receive the usual support provided to clubs accredited as Level 3 clubs with the Australian Drug Foundation's Good Sports program. This support typically consists of one occasion of either phone of face-to-face contact from a Project Officer per year.
Control group
Active

Outcomes
Primary outcome [1] 292459 0
1) the proportion of clubs’ implementing equal to or greater than 10 of 13 alcohol management practices at follow-up assessed through direct observation at sporting clubs during game days. Analysed using logistic regression model
Timepoint [1] 292459 0
Baseline data collection: May-July 2015 Post-intervention data collection: May-July 2017
Primary outcome [2] 302189 0
2) the mean number of alcohol management practices being implemented at follow up assessed through direct observation at sporting clubs during game days. Analysed using linear regression model.
Timepoint [2] 302189 0
Baseline data collection: May-July 2015 Post-intervention data collection: May-July 2017
Secondary outcome [1] 309012 0
The proportion of club members who report drinking alcohol at risky levels at sporting clubs. This outcome is measured by a graduated frequency index and risky drinking is defined as 5 or more standard drinks of alcohol on one drinking occasion.
Timepoint [1] 309012 0
Baseline data collection: July-August 2015
Post-intervention data collection: July-August 2017
Secondary outcome [2] 309016 0
The proportion of club members at risk of alcohol-related harm, as measured by a total Alcohol Use Disorder Identification Test (AUDIT) score of 8 or more.
Timepoint [2] 309016 0
Baseline data collection: July-August 2015
Post-intervention data collection: July-August 2017

Eligibility
Key inclusion criteria
Eligibility criteria for sporting clubs:
- are a non-elite senior community Australian Rules (AFL), Rugby League, Rugby Union or Soccer club;
- have held Level 3 accreditation with the Australian Drug Foundation's Good Sports program for a period of at least 12 months;
- are undertaking at least 80% of the alcohol management practices required by the program;
- hold a valid liquor licence and sell alcohol;
- are located within the state of Victoria or the Hunter New England Region of the state of New South Wales, Australia; and
- have access to the internet.

Eligibility criteria for sporting club members:
- are currently affiliated with a participating sporting club (eg. player, spectator, official);
- are over 18 years of age;
- speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Do not satisfy the above listed inclusion criteria.

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)
A list of football clubs that are within the study area (Victoria or Hunter New England region of New South Wales) and are accredited at Level 3 with the Australian Drug Foundation's Good Sports Program will be provided to the study team. A representative (eg club president) from these clubs will be sent a study information sheet and one week later contacted and asked to undertake a telephone interview. During the interview the study will be explained and the club will be screened for eligibility and invited to participate in the trial.

The alcohol management practices of consenting clubs will be observed during a match day in order to finalise eligibility assessment and collect baseline data.

Following this assessment, eligible clubs will be randomly allocated to the intervention or control condition by an independent statistician who does not have access to baseline data, and is not involved in intervention delivery, data collection or analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clubs will be allocated (using a Microsoft Excel random-number generator) to intervention or control conditions using simple randomisation in a 1:1 ratio, stratified by the state of Australia in which they are located, football code and club size.
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
Efficacy
Statistical methods / analysis
A total of 120 sports clubs will be recruited. The primary trial outcome will be assessed by examining group differences at follow-up in the prevalence of clubs meeting 80% of alcohol management practices using Chi-square tests under an intention to treat approach. Sensitivity analysis will be performed to test a range of assumptions for missing data at follow-up.

Assuming at follow-up that 70% of clubs in the control group have maintained the required alcohol management practices (that is, the prevalence in the control group falls from 100% at baseline to 70% at follow-up), a sample size of 60 clubs per group will be sufficient to detect an absolute difference of 20% between groups at followup (which assumes that the prevalence in the intervention group falls from 100% at baseline to 90% at follow-up) with 80% power and alpha of 0.05.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2015
Actual
15/07/2014
Date of last participant enrolment
Anticipated
Actual
9/01/2015
Date of last data collection
Anticipated
31/07/2017
Actual
31/07/2017
Sample size
Target
120
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 289510 0
Government body
Name [1] 289510 0
Australian Research Council
Country [1] 289510 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 288193 0
Government body
Name [1] 288193 0
Hunter New England Local Health District
Address [1] 288193 0
Lookout Road, Lambton, NSW, 2305
Country [1] 288193 0
Australia
Secondary sponsor category [2] 288194 0
University
Name [2] 288194 0
Deakin University
Address [2] 288194 0
1 Gheringhap Street, Geelong, Victoria, 3220
Country [2] 288194 0
Australia
Secondary sponsor category [3] 288196 0
Charities/Societies/Foundations
Name [3] 288196 0
Australian Drug Foundation
Address [3] 288196 0
Level 12, 607 Bourke Street, Melbourne, Victoria, 3000
Country [3] 288196 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291256 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 291256 0
Research Services
Research Integrity Unit
The Chancellery
The University of Newcastle
University Drive
Callaghan NSW 2308
Ethics committee country [1] 291256 0
Australia
Date submitted for ethics approval [1] 291256 0
Approval date [1] 291256 0
13/03/2014
Ethics approval number [1] 291256 0
H-2013-0429

Summary
Brief summary
The Research Team recently conducted a randomised controlled trial demonstrating that a capacity building intervention (‘Good Sports’) was effective in increasing compliance of licensed community football clubs with liquor licensing laws, and reducing excessive alcohol consumption by club members. If the benefits of such interventions are to be ongoing, the changes adopted by sporting clubs need to be sustained over time. Research that describes the sustainability of health promoting policies and practices in community settings generally, and in sports clubs specifically, is limited. The proposed research will be the first randomised trial investigating the effectiveness of web-based intervention in sustaining best-practice alcohol management practices by community sport clubs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48334 0
Prof John Wiggers
Address 48334 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 48334 0
Australia
Phone 48334 0
+61 2 4924 6247
Fax 48334 0
Email 48334 0
[email protected]
Contact person for public queries
Name 48335 0
Dr Luke Wolfenden
Address 48335 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 48335 0
Australia
Phone 48335 0
+61 2 4924 6567
Fax 48335 0
Email 48335 0
[email protected]
Contact person for scientific queries
Name 48336 0
Dr Luke Wolfenden
Address 48336 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 48336 0
Australia
Phone 48336 0
+61 2 4924 6567
Fax 48336 0
Email 48336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Club and individual level data, collected via observational methods and telephone interviews
When will data be available (start and end dates)?
01/01/2018-TBA
Available to whom?
Contact should be made with the listed researchers to request any data
Available for what types of analyses?
Contact should be made with the listed researchers to discuss
How or where can data be obtained?
Contact should be made with the listed researchers to discuss


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
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial of a web-based programme in sustaining best practice alcohol management practices at community sports clubs: A study protocol.2018https://dx.doi.org/10.1136/bmjopen-2017-017796
N.B. These documents automatically identified may not have been verified by the study sponsor.