Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000831987
Ethics application status
Approved
Date submitted
2/08/2011
Date registered
5/08/2011
Date last updated
5/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of designated driver initiative on sporting club member drinking intentions: a randomised hypothetical scenario study
Scientific title
Sporting club member's drinking intentions at a celebration in response to a hypothetical designated driver program.
Secondary ID [1] 262764 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption 270474 0
Condition category
Condition code
Public Health 270630 270630 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For this study, participants will complete just 1 survey. Following the collection of participant demographic and health behaviour information, sports club members will be read the following statement during a telephone interview:

"I would like you to imagine that your sporting team has just
played and won a competition game. After the game you and other club members decide to celebrate at a local licensed venue. The venue has live music, and a sells meals but is not within walking distance from where you live.

A fellow member of the club agrees to be designated driver and
drive you home after the celebrations."
Intervention code [1] 267107 0
Prevention
Comparator / control treatment
For this study, participants will complete just 1 survey. Following the collection of participant demographic and health behaviour information, sports club members will be read the following statement during a telephone interview:

"I would like you to imagine that your sporting team has just
played and won a competition game. After the game you and other club members decide to celebrate at a local licensed venue. The venue has live music, and a sells meals but is not within walking distance from where you live."
Control group
Active

Outcomes
Primary outcome [1] 269357 0
Alcohol consumption intentions. Participants will be asked to report the number of standard alcoholic drinks they would consume during the hypothetical celebration.
Timepoint [1] 269357 0
The study is a experimental trial being conducted as part of a cross sectional survey. Therefore this data will be collected once only, immediately after description of the hypothetical scenario.
Secondary outcome [1] 279443 0
Other anticipated benefits of alcohol consumption. Participants will be asked to respond on a 4 point liket scale (strongly agree, agree, disagree or strongly disagree) if they think they will be able to connect easily with their team mates during the
celebration.
Timepoint [1] 279443 0
The study is a experimental trial being conducted as part of a cross sectional survey. Therefore this data will be collected once only, immediately after description of the hypothetical scenario.
Secondary outcome [2] 279444 0
Other anticipated benefits of alcohol consumption. Participants will be asked to respond on a 4 point liket scale (strongly agree, agree, disagree or strongly disagree) if they think they will have a lot of fun during the celebration
Timepoint [2] 279444 0
The study is a experimental trial being conducted as part of a cross sectional survey. Therefore this data will be collected once only, immediately after description of the hypothetical scenario.
Secondary outcome [3] 279445 0
Other anticipated benefits of alcohol consumption. Participants will be asked to respond on a 4 point likert scale (strongly agree, agree, disagree or strongly disagree) if they think they will have opportunities for sexual activity following
the celebrations
Timepoint [3] 279445 0
The study is a experimental trial being conducted as part of a cross sectional survey. Therefore this data will be collected once only, immediately after description of the hypothetical scenario.
Secondary outcome [4] 279446 0
Other anticipated benefits of alcohol consumption. Participants will be asked to respond on a 4 point likert scale (strongly agree, agree, disagree or strongly disagree) if they think they will be able to relax during the celebrations
Timepoint [4] 279446 0
The study is a experimental trial being conducted as part of a cross sectional survey. Therefore this data will be collected once only, immediately after description of the hypothetical scenario.
Secondary outcome [5] 279447 0
Other anticipated benefits of alcohol consumption. Participants will be asked to respond on a 4 point liket scale (strongly agree, agree, disagree or strongly disagree) if they think they will feel safe during the celebrations
Timepoint [5] 279447 0
The study is a experimental trial being conducted as part of a cross sectional survey. Therefore this data will be collected once only, immediately after description of the hypothetical scenario.
Secondary outcome [6] 279448 0
Participants will be asked to respond how they think they would get home from the celebration. Participant responses will be used to determine if participants will be at risk of drink driving.
Timepoint [6] 279448 0
The study is a experimental trial being conducted as part of a cross sectional survey. Therefore this data will be collected once only, immediately after description of the hypothetical scenario.

Eligibility
Key inclusion criteria
Participants will be members of community rugby league, soccer, rugby union or Australian Rule Football clubs from the Sydney, and Hunter New England regions of NSW; surveyed as part of a randomised controlled trial of a club based alcohol accreditation intervention, who could speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Participants from a previously recruited cohort participating in a sporting club based randomised controlled trial will be telephoned and randomly assigned to experimental or control conditions in a 1:1 ratio. Allocation was performed by central randomisation procedure using a random number function embedded in the telephone computer software, following eligibility assessment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation procedure will be used using a computer generated random number generator within the computerised telephone survey software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269588 0
Government body
Name [1] 269588 0
Hunter New England Area Health Service
Country [1] 269588 0
Australia
Primary sponsor type
Individual
Name
Luke Wolfenden
Address
Locked Bag 10,
Wallsend, NSW, 2298
Country
Australia
Secondary sponsor category [1] 266619 0
None
Name [1] 266619 0
Address [1] 266619 0
Country [1] 266619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269538 0
Human Research Ethics Committee
Ethics committee address [1] 269538 0
Research Services
Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 269538 0
Australia
Date submitted for ethics approval [1] 269538 0
Approval date [1] 269538 0
01/08/2011
Ethics approval number [1] 269538 0
H-2008-0432

Summary
Brief summary
The trial aims to assess if designated driver programs may increase alcohol consumption intentions of community football club members. Participants will be randomised to receive a hypothetical scenario describing a post match celabration, or an identical scenario which also indicates that participants would have access to a designated driver to transport the participant home following the celebration. Participants will then be asked to indicate the quantity of alcohol they would intend to consume given this scenario.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 32968 0
Address 32968 0
Country 32968 0
Phone 32968 0
Fax 32968 0
Email 32968 0
Contact person for public queries
Name 16215 0
Luke Wolfenden
Address 16215 0
c/o Hunter New England Population Health,
Locked Bag 10
Wallsend, NSW, 2298
Country 16215 0
Australia
Phone 16215 0
+61249246567
Fax 16215 0
+61249246247
Email 16215 0
[email protected]
Contact person for scientific queries
Name 7143 0
Luke Wolfenden
Address 7143 0
c/o Hunter New England Population Health,
Locked Bag 10
Wallsend, NSW, 2298
Country 7143 0
Australia
Phone 7143 0
+61249246567
Fax 7143 0
+61249246247
Email 7143 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe impact of a hypothetical designated driver program on intended alcohol-related behavior: an RCT.2015https://dx.doi.org/10.1093/heapro/dau075
N.B. These documents automatically identified may not have been verified by the study sponsor.