Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000885594
Ethics application status
Approved
Date submitted
7/06/2024
Date registered
19/07/2024
Date last updated
19/07/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the reach and engagement of three anti-vaping messages among young Australian adults aged 18-34 through a social media campaign.
Scientific title
Reach and engagement of three social media-based anti-vaping messages that is targeting young Australian adults aged 18-34 years
Secondary ID [1] 312121 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health promotion 333783 0
Vaping addiction 334322 0
Vaping 334323 0
Condition category
Condition code
Public Health 330452 330452 0 0
Health promotion/education
Mental Health 330981 330981 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two social media intervention messages will address the environmental risks associated with vaping and anti-vape industry sentiments. From an environmental perspective, the intervention will highlight that disposable vapes are difficult to recycle and, therefore, harmful to the environment. Regarding the anti-vape industry perspective, the intervention will stress that vape companies exploit the hard-earned money of young adults, which could be spent more wisely.

The A/B/C testing algorithm will be set to ensure the participants are evenly split in numbers by using the same advertisement costs for each and to ensure that only one of the three messages is 'pushed' to each participant's account. Therefore, the A/B/C testing is equivalent to randomisation and allocation concealment in a randomised design.

The campaign will span three months, and participants will receive a unique message from one of three ads at least once per day on their Facebook feed for the duration of the campaign. If there is no observed reach and engagement for a one-week period, we will cease data collection even if the three-month campaign period is not yet completed.

In this design, each participant will only be able to see one message on their Facebook feed. However, we cannot control which vape messages participants view, nor can we restrict the audiences from being exposed to a different vape message shared by their peers, different from the one to which they were originally randomised.

Each message will include a static text message with emojis and an image.

To monitor or assess adherence to interventions, data from Meta backend will be collected.
Intervention code [1] 328570 0
Lifestyle
Comparator / control treatment
Given that health-themed messages are the most common perspective chosen for health promotion campaigns, the health risks perspective message will be defined as the control group. For this perspective, the intervention in the control group will emphasize that vaping does not relieve stress and may exacerbate it.

The A/B/C testing algorithm will be set to ensure the participants are evenly split in numbers by using the same advertisement costs for each and to ensure that only one of the three messages is 'pushed' to each participant's account. Therefore, the A/B/C testing is equivalent to randomisation and allocation concealment in a randomised design.

The campaign will span three months, and participants will receive a unique message from one of three ads at least once per day on their Facebook feed for the duration of the campaign. If there is no observed reach and engagement for a one-week period, we will cease data collection even if the three-month campaign period is not yet completed.

In this design, each participant will only be able to see one message on their Facebook feed. However, we cannot control which vape messages participants view, nor can we restrict the audiences from being exposed to a different vape message shared by their peers, different from the one to which they were originally randomised.

Each message will include a static text message with emojis and an image.

To monitor or assess adherence to interventions, data from Meta backend will be collected.
Control group
Active

Outcomes
Primary outcome [1] 338218 0
Engagement rate as a measure of effectiveness of anti-vaping messages,
Timepoint [1] 338218 0
For the 3-month duration of the ad campaign, from the beginning of the ad campaign until the end (3-month duration).
Secondary outcome [1] 435020 0
Network size as a measure of effectiveness of anti-vaping messages,
Timepoint [1] 435020 0
For the 3-month duration of the ad campaign, from the beginning of the ad campaign until the end (3-month duration).
Secondary outcome [2] 435021 0
Eigenvector centrality as a measure of effectiveness of anti-vaping messages for a specific participant.
Timepoint [2] 435021 0
For the 3-month duration of the ad campaign, from the beginning of the ad campaign until the end (3-month duration).

Eligibility
Key inclusion criteria
Facebook users located in Australia, who are in the target age range of 18 to 34 years old.
Minimum age
18 Years
Maximum age
34 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
We will use the A/B/C testing function embedded in Meta Ads Manager to allocate one of the three test messages to viewers of a Facebook page. The algorithm for assigning a Facebook user to a message is a random process conducted from within Facebook. This random allocation process is not shown to the research team or users. Thus, assignment to the A/B/C condition is equivalent to randomisation and allocation concealment in a randomised design.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The A/B/C testing algorithm will be set to ensure that participants are evenly split in terms of numbers. The algorithm will be set to allow only one of the three messages to be ‘pushed’ to each participant’s account.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size has been calculated based on the chi-square test. The expected engagement rates are 4%, 7% and 7% for health, environment and anti-vaping themes, respectively. A sample size of 904 per group is required (n=2711 in total, alpha 0.05, 80% power).

Descriptive statistics for the three themed messages will summarise the reach and engagement metrics. Chi-square tests will be used to test the relationships between engagement and message themes, allowing for comparison across the three groups. In addition, network visualisations for the three themes will be used to depict diffusion networks according to the observed nodes and ties. The diffusion network will focus on drawing a complete network of participants involved in the campaign.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2024
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
2711
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316478 0
Charities/Societies/Foundations
Name [1] 316478 0
The Global Network for Academic Public Health
Country [1] 316478 0
United States of America
Primary sponsor type
Individual
Name
Robyn Gillespie. University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 318653 0
Individual
Name [1] 318653 0
Lisa Smithers. University of Wollongong
Address [1] 318653 0
Country [1] 318653 0
Australia
Secondary sponsor category [2] 318689 0
Individual
Name [2] 318689 0
Alberto Nettel-Aguirre. University of Wollongong
Address [2] 318689 0
Country [2] 318689 0
Australia
Secondary sponsor category [3] 318698 0
Individual
Name [3] 318698 0
Xiao Li. University of Wollongong
Address [3] 318698 0
Country [3] 318698 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315272 0
The University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 315272 0
Ethics committee country [1] 315272 0
Australia
Date submitted for ethics approval [1] 315272 0
Approval date [1] 315272 0
23/04/2024
Ethics approval number [1] 315272 0
2023/219

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

Contacts
Principal investigator
Name 134190 0
Prof Lisa Smithers
Address 134190 0
School of Health and Society, Unviersity of Wollongong, Northfields Avenue, Wollongong NSW 2500
Country 134190 0
Australia
Phone 134190 0
+61 2 4221 5435
Fax 134190 0
Email 134190 0
[email protected]
Contact person for public queries
Name 134191 0
Xiao Li
Address 134191 0
School of Health and Society, University of Wollongong, Northfields Avenue, Wollongong, NSW 2500
Country 134191 0
Australia
Phone 134191 0
+61 0 420 656 630
Fax 134191 0
Email 134191 0
[email protected]
Contact person for scientific queries
Name 134192 0
Xiao Li
Address 134192 0
School of Health and Society, University of Wollongong, Northfields Avenue, Wollongong, NSW 2500
Country 134192 0
Australia
Phone 134192 0
+61 0 420 656 630
Fax 134192 0
Email 134192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval does not extend to sharing data.


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.