Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000823471
Ethics application status
Approved
Date submitted
11/07/2025
Date registered
31/07/2025
Date last updated
31/07/2025
Date data sharing statement initially provided
31/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Alcohol culture change for positive ageing
Scientific title
Alcohol culture change for positive ageing: a randomised controlled trial to assess the acceptability and impact of a video-based peer-normalisation intervention directed towards potentially hazardous drinkers aged 50-79 years.
Secondary ID [1] 314583 0
Nil known
Universal Trial Number (UTN)
U1111-1323-7709
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risky alcohol use 337690 0
Condition category
Condition code
Public Health 334025 334025 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) DESCRIPTION OF SURVEY SCHEDULE
There will be three surveys conducted at three time points, with each survey running for approximately 20 minutes:
(a) t0 survey: the baseline survey which will also screen for participant eligibility;
(b) t1 survey: participants will be invited to this survey approximately 48 hours after completing the baseline survey, and the t1 survey will include embedded short intervention or control videos; and
(c) t2 survey: four week follow up after t1.

(2) DESCRIPTION OF INTERVENTION
The intervention condition is exposure to the alcohol harm reduction short videos co-designed for this trial. Participants in the intervention group will be shown two three-minute videos featuring peers of a similar age discussing their motivations and strategies for reducing alcohol use.

The videos will be embedded in the t1 REDCap survey and delivered individually without direct researcher involvement. The total intervention duration is six minutes, and the order of video presentation will be randomised within REDCap.

To monitor adherence, we will (a) insert hidden multiple timestamp fields in RedCap to calculate whether the time spent on the video section was at least as long as the video duration, and (b) participants will be asked at t1 and at t2 (4 week follow up) to report in quantitative scales and in qualitative open-text fields their impressions and what they recall from the videos.

Participants will receive the intervention in their homes, workplaces or other place of their choosing. The specific location will depend on where the participant is physically located at the time of watching the videos.
Intervention code [1] 331207 0
Behaviour
Comparator / control treatment
The control group will undergo the same research procedures as described above. They will be directed to watch two 3 minute 'healthy ageing' videos. These healthy ageing videos cover topics such as exercise, healthy eating and social connection, but do not contain specific messaging on alcohol harm reduction.
Control group
Active

Outcomes
Primary outcome [1] 341688 0
Attitudes towards non-drinkers - CANS tool
Timepoint [1] 341688 0
t0 (Baseline), t1 (video intervention delivery; primary timepoint), t2 (4-week follow up)
Primary outcome [2] 341712 0
Drinking Refusal Self Efficacy
Timepoint [2] 341712 0
t0 (baseline), t1 (video intervention delivery; primary timepoint), t2 (4-week follow up)
Primary outcome [3] 341940 0
Intention to change personal alcohol use
Timepoint [3] 341940 0
t0 (baseline), t1 (video intervention delivery; primary timepoint), t2 (4-week follow up)
Secondary outcome [1] 448345 0
Personal alcohol consumption norms
Timepoint [1] 448345 0
t0 (baseline), t1 (video intervention delivery), t2 (4-week follow up)
Secondary outcome [2] 449070 0
Perceived peer alcohol consumption norms
Timepoint [2] 449070 0
t0 (baseline), t1 (video intervention delivery), t2 (4-week follow up)
Secondary outcome [3] 449071 0
Past month alcohol use
Timepoint [3] 449071 0
t0 (baseline), t2 (4 week followup)
Secondary outcome [4] 449091 0
Alcohol-related health behaviours (1/7)
Timepoint [4] 449091 0
t2 (4 week follow up)
Secondary outcome [5] 450242 0
Alcohol-related health behaviours (2/7)
Timepoint [5] 450242 0
t2 (4 week follow up)
Secondary outcome [6] 450244 0
Alcohol-related health behaviours (3/7)
Timepoint [6] 450244 0
t2 (4 week follow up)
Secondary outcome [7] 450245 0
Alcohol-related health behaviours (4/7)
Timepoint [7] 450245 0
t2 (4 week follow up)
Secondary outcome [8] 450246 0
Alcohol-related health behaviours (5/7)
Timepoint [8] 450246 0
t2 (4 week follow up)
Secondary outcome [9] 450247 0
Alcohol-related health behaviours (6/7)
Timepoint [9] 450247 0
t2 (4 week follow up)
Secondary outcome [10] 450248 0
Alcohol-related health behaviours (7/7)
Timepoint [10] 450248 0
t2 (4 week follow up)

Eligibility
Key inclusion criteria
1. Residents of Australia
2. Aged between 50 and 79 years old inclusive.
3. "Risky drinkers". Participants have AUDIT-C scores of 3-10 for women, and 4-10 for men. An AUDIT-C score indicating possible hazardous drinking is greater than or equal to 4 for men and greater than or equal to 3 for women. AUDIT-C scores of 11 and 12 suggest possible dependence.
Minimum age
50 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants who are located outside Australia
2. Participants aged 49 years and younger and 80 years and older will be excluded.
3. Participants drinking at lower-risk levels or at levels suggestive of dependence (see above on AUDIT-C scores)
4. Participants with low English language proficiency

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed from the researchers by automating randomisation of participant group allocation within RedCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation will be used through RedCap
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
2/11/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319130 0
Government body
Name [1] 319130 0
National Centre for Healthy Ageing (Commonwealth Government of Australia through the Community Health and Hospitals Program Grant Scheme)
Country [1] 319130 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321594 0
None
Name [1] 321594 0
Address [1] 321594 0
Country [1] 321594 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317724 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 317724 0
Ethics committee country [1] 317724 0
Australia
Date submitted for ethics approval [1] 317724 0
29/11/2022
Approval date [1] 317724 0
06/12/2022
Ethics approval number [1] 317724 0
35902

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

Contacts
Principal investigator
Name 141942 0
Dr Tina Lam
Address 141942 0
Monash Addiction Research Centre, Monash University Peninsula Campus, Level 2, Building D, 47-49 Moorooduc Hwy, Frankston VIC 3199
Country 141942 0
Australia
Phone 141942 0
+61 3 9904 4262
Fax 141942 0
Email 141942 0
[email protected]
Contact person for public queries
Name 141943 0
Tina Lam
Address 141943 0
Monash Addiction Research Centre, Monash University Peninsula Campus, Level 2, Building D, 47-49 Moorooduc Hwy, Frankston VIC 3199
Country 141943 0
Australia
Phone 141943 0
+61 3 9904 4262
Fax 141943 0
Email 141943 0
[email protected]
Contact person for scientific queries
Name 141944 0
Tina Lam
Address 141944 0
Monash Addiction Research Centre, Monash University Peninsula Campus, Level 2, Building D, 47-49 Moorooduc Hwy, Frankston VIC 3199
Country 141944 0
Australia
Phone 141944 0
+61 3 9904 4262
Fax 141944 0
Email 141944 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Ethical approval will be required prior to data access



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.