Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001038886
Ethics application status
Approved
Date submitted
29/06/2021
Date registered
6/08/2021
Date last updated
8/07/2022
Date data sharing statement initially provided
6/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Digital Health Promotion Resource for Children about Ergonomic Ways of Using Information and Communication Technologies (ICT)
Scientific title
Evaluating the effectiveness of a Digital Health Promotion Resource in improving children's knowledge, attitude, subjective norms, perceived behavioural control, and behaviours relating to ergonomic ways of using technology.
Secondary ID [1] 304623 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incorrect posture 322857 0
Condition category
Condition code
Musculoskeletal 320194 320194 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The digital health promotion intervention, called TECHgonomics, is a web-based digital health promotion resource that has been developed in Australia for children aged 12 to 13 years, to promote ergonomic ways of using technology. Development of this resource was informed by a combination of evidence-based strategies reported in the research literature and a co-design approach with Year 7 school children in Perth, Western Australia. The resource comprises three modules and contains the following features:

1. Learning components comprised of role model videos, written information, and images
2. Interactive quizzes
3. Leaderboard
4. Interactive body charts indicating common areas of pain/discomfort
5. Discussion blog
6. Ergonomic diary for self-monitoring of ergonomic ways of using technology

A controlled trial will be used to determine the effectiveness of the TECHgonomics digital health promotion resource in improving children's knowledge, attitude, subjective norms, perceived behavioural control, and behaviours relating to ergonomic ways to use ICT. The trial will be a cluster group, two-arm trial, in which outcomes for participants in the
intervention group will be compared to outcomes for participants in the control group.
Participants in the intervention group will be from one co-educational high school while participants in the control group will be from another co-educational high school, to reduce the risk of contamination. Participants in the intervention group
will be given access to use the TECHgonomics digital health promotion resource at school and/or at home for 8 weeks, while the control group will not be given access to use the resource during the study period. Outcomes of knowledge, attitude, subjective norms, perceived behavioural control, and behaviours will be measured at
baseline (T1) prior to the commencement of the trial and post-assessment (T2) at the end of the 8-week trial period. Demographic information, including age, gender, residential postcode (to determine socioeconomic status), and school year level for all participants will also be collected at baseline. The trial will take place over 8 weeks from August 2021 to October 2021.
Participants will be asked to spend 30 mins every week at school and/or at home over 8 weeks to use the digital health promotion resource. Adherence to the intervention will be monitored using website data analytics.
Intervention code [1] 320989 0
Behaviour
Comparator / control treatment
The control group will not receive access to use the TECHgonomics digital health promotion intervention/resource during the 8-week trial period.
Control group
Active

Outcomes
Primary outcome [1] 328072 0
Change in postural behaviour as assessed with the Ergonomic Use of Technology-Behaviour Questionnaire.
Timepoint [1] 328072 0
Baseline (T1) and Post-assessment (T2)
Secondary outcome [1] 397480 0
Knowledge of ergonomic behaviours as assessed by the Healthy Computing Questionnaire for Children (HCQC).
Timepoint [1] 397480 0
Baseline (T1) and Post-assessment (T2)
Secondary outcome [2] 398316 0
Attitude as assessed by the Healthy Computing Questionnaire for Children (HCQC).
Timepoint [2] 398316 0
Baseline (T1) and Post-assessment (T2)
Secondary outcome [3] 398317 0
Subjective norms as assessed by the Healthy Computing Questionnaire for Children (HCQC).
Timepoint [3] 398317 0
Baseline (T1) and Post-assessment (T2).
Secondary outcome [4] 398318 0
Perceived Behavioural Control as assessed by the Healthy Computing Questionnaire for Children (HCQC).
Timepoint [4] 398318 0
Baseline (T1) and Post-assessment (T2).

Eligibility
Key inclusion criteria
A sample of 140 school children aged 12- 13 years will be eligible to be recruited for this study if they meet the following criteria:

1. Living in Perth, Western Australia.
2. Able to read and write in English at an Australian Education Year 5 level.
3. Enrolled in Year 7 or 8 at a co-educational high school in Perth, Western Australia.
4. Possess basic computer skills to enable use of the digital health promotion resource.
Minimum age
12 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children that are already participating in another study relating to ergonomic ways of using technology.

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)
The two participating schools will be randomised to determine which school will be the intervention group (n=70) or the control group (n=70), and will be determined based on a coin toss completed by a researcher who will have no involvement in the trial. This researcher will
also not have any information about the two schools that will be participating in the trial at the time of randomisation and allocation, and the treatment will also be concealed from them at this stage.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A controlled trial will be used to determine the effectiveness of the TECHgonomics digital health promotion resource in improving children's knowledge, attitude, subjective norms, perceived behavioural control, and behaviours relating to ergonomic ways to use ICT. The trial will be a cluster group two-arm trial, in which outcomes for participants in the intervention group will be compared to outcomes for participants in the control group.

Participants in the intervention group will be from one co-educational high school while participants in the control group will be from another co-educational high school, to reduce the risk of contamination. Participants in the intervention group will be given access to use the TECHgonomics digital health promotion resource at school and/or at home, while the control group will not be given access to use the resource during the study period.

Outcomes of knowledge, attitude, subjective norms, perceived behavioural control, and behaviours will be measured at baseline (T1) prior to the commencement of the trial and post-assessment (T2) at the end of the 8-week trial period. Demographic information, including age, gender, residential postcode (to determine socioeconomic status), and school year level for all participants will also be collected at baseline. The trial will take place over 8 weeks from August 2021 to October 2021.

Altman's nomogram equation was used to determine the sample size for the trial. A sample size of 120 (n=60 in each group) allows for detection of a moderate effect for outcomes (Cohen's d of 0.5), a ß-level of 0.8, and a-level of 0.05. The researchers aim to recruit a total of 140 participants (n=70 in each group) for this study having taken into account the possibility of attrition.

The outcomes pertaining to children's knowledge, attitude, subjective norms, perceived behavioural control, and behaviours relating to ergonomic use of technology will be assessed at baseline (T1) and post-assessment (T2). Outcomes will be compared within-group and between group to determine any differences.
In the baseline and post-assessment questionnaire, questions to assess knowledge, attitude, subjective norms, and perceived behavioural control were adapted from the Healthy Computing Questionnaire for Children (HCQC). This outcome measure has established validity and has excellent intra-rater reliability. A self-report questionnaire about ergonomic behaviours when using technology was developed by the student researcher for this study, as there is currently no known suitable self-report outcome measure. Items in this outcome measure were reviewed by the research team and piloted with 20 children. Subsequent minor modifications were made to the outcome measure. As the psychometric properties of this outcome measure are not yet known, data from this outcome measure will be interpreted and reported with caution.
Simple descriptive statistics will be used to summarise the demographic profiles of the participants. A Kolmogorov-Smirnov test will be performed to determine the normality of any continuous data. An independent t-test will be used to compare the profiles of the participants between the intervention and control groups for normally distributed continuous data (or Mann-Whitney U-test for non-normally distributed data). Between-group differences for ordinal and categorical demographic data will be determined using Chi-square. The effectiveness of the intervention in improving the outcomes will be determined by calculating the change from T1 to T2, and comparing within- and between-group changes using paired and independent t-tests (or Wilcoxon Signed rank test and Mann Whitney U test for non-parametric continuous data), and Chi-square for categorical and ordinal data. If analysis identifies baseline characteristic differences between the intervention and control groups, this will be adjusted using a General Liner Model (GLM). An intention-to-treat analysis will be used, where participants will be classified as belonging to the group to which they were initially allocated. Participants who did not provide outcome data at T2 will still be included in the trial, and their T1 data will be used at T2. The Statistical Package for the Social Sciences (IBM SPSS Statistics) will be used to analyse the data, and a p-value of <0.05 will be used to indicate statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/09/2022
Actual
Date of last participant enrolment
Anticipated
1/10/2022
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308984 0
University
Name [1] 308984 0
Curtin University
Country [1] 308984 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, WA 6102
Country
Australia
Secondary sponsor category [1] 309920 0
None
Name [1] 309920 0
N/A
Address [1] 309920 0
N/A
Country [1] 309920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308875 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 308875 0
Ethics committee country [1] 308875 0
Australia
Date submitted for ethics approval [1] 308875 0
21/06/2021
Approval date [1] 308875 0
27/05/2022
Ethics approval number [1] 308875 0
HRE2021-0422

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

Contacts
Principal investigator
Name 112186 0
Mr Kavaish Krishna
Address 112186 0
Curtin University,
Kent Street, Bentley, WA 6102
Country 112186 0
Australia
Phone 112186 0
+61 405395253
Fax 112186 0
Email 112186 0
[email protected]
Contact person for public queries
Name 112187 0
Kavaish Krishna
Address 112187 0
Curtin University,
Kent Street, Bentley, WA 6102
Country 112187 0
Australia
Phone 112187 0
+61 405395253
Fax 112187 0
Email 112187 0
[email protected]
Contact person for scientific queries
Name 112188 0
Kavaish Krishna
Address 112188 0
Curtin University,
Kent Street, Bentley, WA 6102
Country 112188 0
Australia
Phone 112188 0
+61 405395253
Fax 112188 0
Email 112188 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
Participants aged 12 to 13 years are considered mature minors. Individual participant data is deemed private and confidential.


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.