Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000627752
Ethics application status
Approved
Date submitted
6/04/2022
Date registered
28/04/2022
Date last updated
16/12/2022
Date data sharing statement initially provided
28/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Interactive SNAP (Smoking/Nutrition/Alcohol/Physical Activity) program for adolescents delivered with Augmented Reality technology: A Qualitative Study
Scientific title
Interactive SNAP program for adolescents delivered with Augmented Reality technology: A Qualitative Study
Secondary ID [1] 306725 0
NHMRC – Grant Number GNT1141521
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Smoking 325705 0
Poor nutrition 325706 0
Excessive alcohol consumption 325707 0
Physical Inactivity 325708 0
Condition category
Condition code
Public Health 323053 323053 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This novel AR intervention will be demonstrated via a recorded video of the primary investigator accessing the AR poster via Zappar. The participants will not use the AR intervention themselves as part of our study. The content covered during the demonstration will be purely how to access the educational content. Video will normally be displayed via Zoom call, but in the case of an audio only interview, a link to an online video of the demonstration will be provided.

A preliminary questionnaire will be available to complete prior to interviews. Preliminary interview is expected to take 20 minutes, 25 minutes if questionnaire completion required, demonstration is expected to take less than 5 minutes, followed by a post test interview of approximately 30 minutes, including verbally running through the follow up questionnaire.

All interviews will be conducted remotely, either via Zoom call or telephone.

All interviews will be conducted by the primary investigator.
Intervention code [1] 323326 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331006 0
Determining overall participant acceptance of the AR educational resources, assessed using the Theoretical Framework of Acceptability via one-on-one semi structured interviews delivered via Zoom video or telephone call
Timepoint [1] 331006 0
Immediately after AR demonstration video
Secondary outcome [1] 408462 0
Using the System Usability Scale to measure the participants view regarding the usability of our intervention
Timepoint [1] 408462 0
Interviews will be structured with short interview, demonstration video, follow up questionnaire, follow up interview, and finished with System Usability Scale questions, all within a single continuous 60 minute interview.
Secondary outcome [2] 408798 0
Assessing an adolescents opinion on the acceptability of AR health education resources for adolescents using one-on-one semi structured interviews delivered via Zoom video or telephone call.

Areas to be assessed include all areas of Theoretical framework of Acceptability, including affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy.
Timepoint [2] 408798 0
Adolescent interviews only

Interviews will be structured with short interview, demonstration video, follow up questionnaire, follow up interview, and finished with System Usability Scale questions, all within a single continuous 60 minute interview.
Secondary outcome [3] 408799 0
Assessing a parents opinion on the acceptability of AR health education resources for adolescents using one-on-one semi structured interviews delivered via Zoom video or telephone call.

Areas to be assessed include all areas of Theoretical framework of Acceptability, including affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy.
Timepoint [3] 408799 0
Parent interviews only

Interviews will be structured with short interview, demonstration video, follow up questionnaire, follow up interview, and finished with System Usability Scale questions, all within a single continuous 60 minute interview.
Secondary outcome [4] 408800 0
Assessing a health professionals opinion on the acceptability of AR health education resources for adolescents using one-on-one semi structured interviews delivered via Zoom video or telephone call.

Areas to be assessed include all areas of Theoretical framework of Acceptability, including affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy.
Timepoint [4] 408800 0
Health professional interviews only

Interviews will be structured with short interview, demonstration video, follow up questionnaire, follow up interview, and finished with System Usability Scale questions, all within a single continuous 60 minute interview.

Eligibility
Key inclusion criteria
1) Adolescents aged 13-18 years old

Adolescents must be between the ages of 13-18 years of age when the interviews are performed and have a parent or caregiver willing to provide written consent.

2) Parents of adolescents aged 13-18 years old

Parents/caregivers must have at least one child in the age range of 13-18 years of age when interviews are performed,

3) Health professionals (doctors, nurses and allied health professionals)

Health professionals must have been practising in their field at least 12 months.
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All participants much be able to communicate comfortably in both written and verbal English and have no intellectual or cognitive impairment that would limit their ability to give informed consent.

Adolescents must be between the ages of 13-18 years of age when the interviews are performed and have a parent or caregiver willing to provide written consent.

Parents/caregivers must have at least one child in the age range of 13-18 years of age when interviews are performed, see time period above.

Health professionals must have been practising in their field at least 12 months, see time period above.

While not an exclusion criteria; If a participant is known to a member of the investigator team, another member of the team will complete the interviews and analysis process, so that any confidential personal information is not available for any known individuals.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Kim, Sefcik and Bradway (2017) indicated smaller sample sizes (11-20) were suitable for Qualitative Descriptive research, especially when the primary data collection tool are interviews. When Hennink, Kaiser and Marconi (2017) analysed transcripts of semi-structured interviews, researchers found that 91% of the codes were identified by the sixth interview.

Transcripts developed from processing audio recordings will be coded using the Theoretical Framework of Acceptability/Theoretical Domains Framework and the System Usability Scale. Coding will occur by two independent researchers, using NViVo software, with results reported through narrative synthesis. Quantitative data will be pooled together for means, standard deviations and ranges. Qualitative data will be coded to organize the texts into themes, to help the researchers to identify barriers or enablers for this intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/05/2022
Actual
7/05/2022
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
21
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22146 0
South Australian Health and Medical Research Institute (SAHMRI) - Adelaide
Recruitment hospital [2] 22147 0
UniSA Health and Medical Clinic (City West) - Adelaide
Recruitment postcode(s) [1] 37269 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 311056 0
Government body
Name [1] 311056 0
National Health and Medical Research Council (NHMRC)
Country [1] 311056 0
Australia
Primary sponsor type
University
Name
UniSA City East
Address
Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 312385 0
None
Name [1] 312385 0
Address [1] 312385 0
Country [1] 312385 0
Other collaborator category [1] 282242 0
Other
Name [1] 282242 0
South Australian Health and Medical Research Institute (SAHMRI)
Address [1] 282242 0
North Terrace, Adelaide SA 5000
Country [1] 282242 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310601 0
UniSA's Human Research Ethics Committee (HREC)
Ethics committee address [1] 310601 0
Ethics committee country [1] 310601 0
Australia
Date submitted for ethics approval [1] 310601 0
02/02/2022
Approval date [1] 310601 0
16/02/2022
Ethics approval number [1] 310601 0
Application ID: 204093

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

Contacts
Principal investigator
Name 118222 0
Mr John Niwa
Address 118222 0
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace, Adelaide SA 5000
Country 118222 0
Australia
Phone 118222 0
+61 414979335
Fax 118222 0
Email 118222 0
simny019@mymail.unisa.edu.au
Contact person for public queries
Name 118223 0
John Niwa
Address 118223 0
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace, Adelaide SA 5000
Country 118223 0
Australia
Phone 118223 0
+61 8 8128 4000
Fax 118223 0
Email 118223 0
simny019@mymail.unisa.edu.au
Contact person for scientific queries
Name 118224 0
Kristin Chahhoud
Address 118224 0
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace, Adelaide SA 5000
Country 118224 0
Australia
Phone 118224 0
+61 412 708 879
Fax 118224 0
Email 118224 0
Kristin.Carson-Chahhoud@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Analysis of anonymized data will be the only information available publicly.


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.