Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000843550p
Ethics application status
Submitted, not yet approved
Date submitted
22/05/2024
Date registered
8/07/2024
Date last updated
8/07/2024
Date data sharing statement initially provided
8/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Posture on Recall of Health Information from a Vaping Website
Scientific title
The Effects of Posture on the Recall of Health Information from a Vaping Website in a Community Sample: A Randomised Trial
Secondary ID [1] 312192 0
AHREC 27885
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
E-cigarette use 333703 0
Condition category
Condition code
Public Health 330383 330383 0 0
Health promotion/education
Mental Health 330535 330535 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manipulation of participants posture while seated (upright, seated posture compared to slumped, seated posture).

Intervention condition:
Upright, seated posture.
Participants randomly allocated to the intervention group will be covertly manipulated into an upright, seated posture while viewing a vaping safety website by adjusting the position of the laptop they are watching the video on. In the intervention condition the laptop will be positioned on a table-top stand so that the screen height is level with the participants eye level, which will endow participants to sit with a straighter back, reducing their head and neck angle. This method for covertly manipulating participants seated posture has been implemented successfully in prior research (Muller et al., 2023).

Intervention location - Clinic room at the University of Auckland Faculty of Medical and Health Sciences Clinical Research Centre

Intervention Materials - The Vaping website that participants will view has been sourced from Healthify He Puna Waiora website produced by Health Navigator Charitable Trust. The Healthify website provides the New Zealand public with access to up-to-date, accurate and evidenced-based health information and self-help resources produced and maintained by experienced medical writers and clinical advisors. Healthify He Puna Waiora is currently endorsed by the Royal New Zealand College of General Practitioners as an online healthcare information resource which is broad, accessible and well informed and researched. The specific Webpage that will be used in the study is titled "Vaping" and can be sourced through this link (https://healthify.nz/hauora-wellbeing/v/vaping/).

Intervention Delivery - Participants will be given specific verbal instructions about what sections of the Vaping webpage they are expected to review and which sections of the website are referenced within the short-answer knowledge quiz they will be completing after interacting with the website. The Healthify Vaping website consists of several expandable tabs each labelled with a subtitle and participants will be instructed to read and watch the material from the first tab subtitled, What is vaping?" through to the tab subtitled, "Side effects of vaping." The researcher will highlight that the second tab subtitled, "VIDEO: A Spotlight on Vaping series" includes an embedded video and that the content in the video may be included in the short-answer knowledge quiz and so should be included also. Participants will be told that they may navigate through the content specified in whatever order they please and that they may view the website material for as long as they desire before informing the researcher that they have finished viewing the website.

Intervention frequency and duration - The intervention involving exposure to the website will take place once only. While participants may view the website for as long as they wish to, it is expected that for most participants this will take 10 to 15 minutes based on mock intervention rehearsals conducted by the research team. The post-intervention questionnaire which will included a free-recall task, short-answer quiz and RABE questionnaire and VAS measure is expected to take 5 to 10 minutes based off mock trial rehearsals conducted within the research team.

Adherence Monitoring - In order to assess the effectiveness of the posture manipulation the intervention will be video recorded with participant consent. The video recording of the intervention will also be used to measure how long participants interact with the website and monitor participants website viewing behaviour (e.g do they view all specified tabs, do they watch the embedded video in full, are there sections that they navigate back to and review). Participants will be told that the purpose of the video recording is for the researchers to be able to review how participants interact with the website and to ensure that participants have in fact read through and watched all content they have bene instructed to.
Additionally, the researcher conducting the study will be present in the room to facilitate the study, provide instructions and answer participant questions, and to troubleshoot any technical issues which may arise. The researcher will also be able to covertly monitor that participants are engaging in the intervention in real time as they will be in the room with the participant throughout the study duration.
Intervention code [1] 328516 0
Behaviour
Intervention code [2] 328517 0
Treatment: Other
Comparator / control treatment
Manipulation of participants posture while seated (upright, seated posture compared to slumped, seated posture).

Comparison condition:
Slumped, seated posture. Participants randomly allocated to the comparison group will be covertly manipulated into adopting a slumped, seated posture while viewing a vaping safety website. In the comparison condition the laptop will be positioned flat on the table-top, causing participants eye gaze to drop, shoulders slump forward, and neck angle increase. This method for covertly manipulating participants seated posture has been implemented successfully in prior research (Muller et al., 2023).

Comparison condition Location:
Clinic room at the University of Auckland Faculty of Medical and Health Sciences Clinical Research Centre

Comparison condition materials and delivery:
As with the intervention condition, participants will be given verbal instructions to read through the Healthify He Puna Waiora website page titled, "Vaping." The content and instructions provided to participants randomly assigned to the comparator condition will not differ in anyway from that specified above for the intervention condition.

Comparison condition Frequency and duration:
Participants will be exposed to the Healthify Vaping webpage once only and will have no specified time restraints on how long they interact with the webpage for. Based off of mock study rehearsals conducted by the researcher with the research team it is expected that this will take approximately 10 to 15 minutes.

Comparator Adherence Monitoring:
As with the intervention condition a digital camera will be set on a tripod adjacent to the desk setup where the participants will sit and interact with the Healthify Vaping webpage and will capture a recording of participants profile. This footage will be used to assess the postural manipulation of the intervention and comparator conditions, measure how long participants interact with the webpage and to review how participants navigated through the website. The researcher facilitating the study session will be in the room and able to discreetly check the laptop screen and whether the participants are following instructions or interfering with the postural manipulation (for example, taking the laptop off the stand).
Control group
Active

Outcomes
Primary outcome [1] 338301 0
Recall of total health information from a Vaping website (Healthify.nz/vaping).
Timepoint [1] 338301 0
The primary outcome will be assessed once following exposure to the website.
Secondary outcome [1] 435358 0
Perceptions of health impacts of vaping
Timepoint [1] 435358 0
Participants perceptions of health impacts of vaping will be assessed at baseline using the RABE, and following exposure to the vaping website (Healthify.nz/vaping) once again using the RABE.
Secondary outcome [2] 435359 0
Arousal
Timepoint [2] 435359 0
Arousal will be measured at baseline prior to the postural manipulation being implemented, and a second time as part of the post-intervention questionnaire which participants will complete once they have finished reading through the Healthify Vaping webpage and while still in the postural manipulation set up corresponding to the condition they have been randomly assigned to.
Secondary outcome [3] 435360 0
Time spent looking at website
Timepoint [3] 435360 0
Once while they are looking at the website
Secondary outcome [4] 435361 0
Total number of words in the free recall task
Timepoint [4] 435361 0
Once after the viewing of the website
Secondary outcome [5] 436259 0
Valence
Timepoint [5] 436259 0
Valence will be measured at baseline prior to the postural manipulation being implemented, and a second time as part of the post-intervention questionnaire which participants will complete once they have finished reading through the Healthify Vaping webpage and while still in the postural manipulation set up corresponding to the condition they have been randomly assigned to.

Eligibility
Key inclusion criteria
Inclusion criteria:
Participants are at least 16 years of age.
Participants are able to read, write and speak English.
Participants are able to fully understand the risks and benefits of the research and provide informed consent.

The inclusion criteria require participants to be a minimum of 16 years of age (meaning they may provide informed consent), as we are interested specifically in the influence posture has on the recall of health information for adults and young adults within the general population.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
Significant visual impairment which prevents participants from reading information from a screen.

The only exclusion criteria, being significant visual impairment, has been set in response to the confines of the experimental design of the study which requires participants to be able to read health information from a website, and complete study measures displayed on
a screen.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software by a researcher not involved in recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A target sample size of 128 participants to be recruited for the proposed study to be
appropriately powered to find a result if one exists following a G*Power calculation. The parameters used were a power level of .80 and a significance of a = 0.05, as is consistent with psychological research conventions. A medium effect size of d=.50 was selected based on previous literature.

Data analysis will be conducted using IBM SPSS software. All data will be inspected for errors, gaps, and outliers. The data will be assessed for normality using Shapiro-Wilk tests and for homogeneity of variance using Leven’s tests. If data does not meet normality assumptions, bootstrapping and non-parametric tests will be used to transform data appropriately. Characteristics of the sample will be assessed using descriptive statistics. Differences in demographic and baseline characteristics between groups will be assessed using Pearson’s Chi-Square test and independent samples t-tests.

To assess the primary hypothesis, differences in the recall of vaping-related health information from the web site between the upright and slumped posture groups will be assessed using independent sample t-tests. Secondary hypotheses will be assessed by conducting repeated measures mixed ANOVA to assess differences in perceptions of risks and benefits of e-cigarette use between groups before and after exposure to the vaping web site. Differences in arousal and valence will be assessed with mixed ANOVA.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment outside Australia
Country [1] 26320 0
New Zealand
State/province [1] 26320 0
Auckland

Funding & Sponsors
Funding source category [1] 316437 0
University
Name [1] 316437 0
The University of Auckland
Country [1] 316437 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318606 0
None
Name [1] 318606 0
Address [1] 318606 0
Country [1] 318606 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315229 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 315229 0
Ethics committee country [1] 315229 0
New Zealand
Date submitted for ethics approval [1] 315229 0
20/05/2024
Approval date [1] 315229 0
Ethics approval number [1] 315229 0

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

Contacts
Principal investigator
Name 134058 0
Prof Elizabeth Broadbent
Address 134058 0
Department of Psychological Medicine, The University of Auckland, Private Bag 92019 Auckland 1142
Country 134058 0
New Zealand
Phone 134058 0
+64 9 3737599
Fax 134058 0
Email 134058 0
[email protected]
Contact person for public queries
Name 134059 0
Elizabeth Broadbent
Address 134059 0
Department of Psychological Medicine, The University of Auckland, Private Bag 92019 Auckland 1142
Country 134059 0
New Zealand
Phone 134059 0
+64 9 3737599
Fax 134059 0
Email 134059 0
[email protected]
Contact person for scientific queries
Name 134060 0
Elizabeth Broadbent
Address 134060 0
Department of Psychological Medicine, The University of Auckland, Private Bag 92019 Auckland 1142
Country 134060 0
New Zealand
Phone 134060 0
+64 9 3737599
Fax 134060 0
Email 134060 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


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.