Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000094572
Ethics application status
Approved
Date submitted
22/12/2023
Date registered
2/02/2024
Date last updated
2/02/2024
Date data sharing statement initially provided
2/02/2024
Date results provided
2/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
From minds to mindsets: drowning interventions and a pathway to the population-scale impacts
Scientific title
Assessing the impact of relationship building between lifeguards and beachgoers on beach behavior through the delivery of skill development sessions on the beach.
Secondary ID [1] 311242 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drowning 332455 0
Condition category
Condition code
Public Health 329149 329149 0 0
Health promotion/education
Injuries and Accidents 329309 329309 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Existing interventions for drowning prevention presume that awareness translates into changed behaviors and rely on ineffective mass communications to progress from individual- to population-scale impact. The quasi-experimental intervention developed here uses a 20-minute beach safety lesson delivered by lifeguards at the beach on the topics of: what the beach safety flags mean, how to identify a rip current, how to safely escape a rip current, and how to safely perform a bystander rescue. Lessons are delivered three times a day at 11am, 1 pm and 3 pm. There will be 10 participants in each lesson. Each participant in the intervention (i.e., lesson) is expected to have attended one lesson and participated in a meaningful engagement that is designed to encourage active reflection that can generate learning and the adoption of risk mitigation behaviors that spillover to non-participants and to other contexts. In our engagements, ‘active processing’ is oriented towards ‘the self’, asking participants to actively consider their own perceptions and behaviors in the context of having just experienced a lesson situated on the beach concerning drowning prevention. Our contention is that external efforts to convince participants through appeals to sympathy might be improved through active personal perspective-experiences, and that reflection on personal experience offers a more situated and persuasive impact pathway towards lasting adoption of drowning prevention behaviors. Strategies used to monitor adherence to the intervention are twofold. The first includes participation in a mixed quantitative survey and qualitative semi-structured interview after participation in the lesson that is designed to assess the impact of the lesson. The second is by conducting follow-up interviews six months following the intervention to assess the impact of the lesson, over time.
Intervention code [1] 327698 0
Behaviour
Intervention code [2] 327793 0
Prevention
Comparator / control treatment
A control sample will also be collected in the same location in the two days following the intervention, with those participants engaged using the same approach, including follow-up interviews six months later. The control sample will however not participate in a safety lesson. The main difference is intervention group will participate in a safety lesson and the control sample will not. This is because we want to assess the impact of participation in a safety lesson on beach going behavior (i.e., intervention) with those who do not (i.e., control).
Control group
Active

Outcomes
Primary outcome [1] 336981 0
A composite primary outcome is a change in drowning prevention knowledge and rip current risk knowledge
Timepoint [1] 336981 0
Learning about drowning prevention and rip current risk will be immediately assessed after the intervention and then assessed again during a follow-up interview 6 months after the intervention.
Secondary outcome [1] 430294 0
A composite secondary outcome is a change in drowning prevention knowledge, rip current risk knowledge and behavior
Timepoint [1] 430294 0
Learning about drowning prevention, rip current risk and behavior change is assessed immediately after the engagement but for this secondary outcome, learning and behavior change will be assessed during a follow-up interview 6 months after the intervention.

Eligibility
Key inclusion criteria
For the intervention, consenting beach-goers that are 18 years old or older and participated in the safety lesson.

Participants in the control must be consenting beach-goers that are 18 years old or older that did not participate in the safety lesson.
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/01/2023
Date of last participant enrolment
Anticipated
Actual
5/01/2023
Date of last data collection
Anticipated
Actual
9/01/2023
Sample size
Target
100
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315498 0
University
Name [1] 315498 0
University of Melbourne
Country [1] 315498 0
Australia
Funding source category [2] 315606 0
Other Collaborative groups
Name [2] 315606 0
Life Saving Victoria
Country [2] 315606 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Surf Life Saving Australia
Address
Level 1, 1 Notts Ave Bondi Beach, NSW 2026
Country
Australia
Secondary sponsor category [1] 317573 0
Other Collaborative groups
Name [1] 317573 0
Life Saving Victoria
Address [1] 317573 0
200 The Blvd, Port Melbourne VIC 3207
Country [1] 317573 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314401 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 314401 0
Ethics committee country [1] 314401 0
Australia
Date submitted for ethics approval [1] 314401 0
10/06/2022
Approval date [1] 314401 0
09/09/2022
Ethics approval number [1] 314401 0
22989

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

Contacts
Principal investigator
Name 131454 0
A/Prof Brian Cook
Address 131454 0
University of Melbourne, 207 Bouverie street, Parkville, VIC 3053
Country 131454 0
Australia
Phone 131454 0
+61 3 9035 8370
Fax 131454 0
Email 131454 0
[email protected]
Contact person for public queries
Name 131455 0
Peter Kamstra
Address 131455 0
University of Melbourne, 207 Bouverie street, Parkville, VIC 3053
Country 131455 0
Australia
Phone 131455 0
+61 3 9035 5511
Fax 131455 0
Email 131455 0
[email protected]
Contact person for scientific queries
Name 131456 0
Peter Kamstra
Address 131456 0
207 Bouverie street, Parkville, VIC 3053
Country 131456 0
Australia
Phone 131456 0
+61 3 9035 5511
Fax 131456 0
Email 131456 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
Once data has been de-identified, it will be available to participants and via public facing reports and peer-reviewed publications.


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.