Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001427561
Ethics application status
Approved
Date submitted
18/11/2024
Date registered
6/12/2024
Date last updated
6/12/2024
Date data sharing statement initially provided
6/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of educational videos about osteoarthritis, diet, and weight management
Scientific title
Impact of educational videos about osteoarthritis, diet, and weight management on diet-related intentions in people with osteoarthritis: a randomised online experiment
Secondary ID [1] 313322 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 335676 0
Condition category
Condition code
Musculoskeletal 332238 332238 0 0
Osteoarthritis
Public Health 332451 332451 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to understand whether communication strategy surrounding diet matters to an individual’s perceived intentions to improve dietary choices. To do so, we will undertake a randomised online study, evaluating two new videos against a currently publicly available, standard informational control video. Creation of each new video was driven and co-designed by 14 people with lived experience of osteoarthritis (consumers), based on consumer recommendations from our previous co-design work (e.g., messaging content/strategies) (DOI: 10.1016/j.joca.2023.03.004). We collaborated with the consumers at the equal partnership level as co-researchers to create the videos. Both new videos address the importance of diet for osteoarthritis and making healthy, anti-inflammatory dietary choices (for eating/cooking), but each uses a different communication strategy.

The two new videos are:
1) Contemporary informational animation
2) Narrative storytelling video

There will be three intervention arms:
Arm 1: Contemporary informational animation + narrative storytelling (6 minutes, 39 seconds)
Arm 2: Contemporary informational animation alone (3 minutes, 11 seconds)
Arm 3: Narrative storytelling alone (3 minutes, 28 seconds)

Contemporary informational animation:
This video is based on how information is typically presented to people with osteoarthritis (i.e., scientific and statistical facts). However, novel features of this video include that it was co-designed with consumers to ensure the scientific information was presented in a consumer-friendly and persuasive manner. It promotes healthy eating rather than weight loss as the main goal for osteoarthritis management using recent scientific findings underpinned by contemporary pain science (e.g., the role of inflammation in osteoarthritis and the effect of diet on inflammation, and thus, osteoarthritis; and challenging the myth that carrying extra weight causes osteoarthritis by making the joint ‘wear out’). The co-design process to create the animation used an iterative approach as follows:
1. Research team drafted a transcript based on consumer recommendations from our previous co-design work (messaging content/strategies), expert nutritionist/dietitian input, recent scientific discoveries about osteoarthritis, and our consumer-facing osteoarthritis resources (e.g., the Knee Osteoarthritis Handbook published by Noigroup).
2. Consumers provided feedback on the draft transcript (via a 1-hour Zoom workshop and/or written feedback) with guiding questions for feedback.
3. Research team updated the transcript and professional animator created a draft animation.
4. Consumers provided feedback on the draft video (via a 1-hour Zoom workshop and/or written feedback) with guiding questions for feedback.
5. Research team updated the transcript based on consumer feedback.
6. Professional animator created the animation prototype to be evaluated in the current study.

Narrative storytelling video:
This video depicts a real person with osteoarthritis (Mr Cookfulness) who describes how they use the act of cooking healthy, using anti-inflammatory ingredients, as therapy. Our consumer partners told us that storytelling/testimonials are a powerful method of inspiring health behaviour change. This is supported by recent research showing that testimonials from people with shared lived experiences, which demonstrate the potential for personal change, can positively influence health-related beliefs, intentions, and behaviours for major public health problems. The co-design process to create the video used an iterative approach as follows:
1. Mr Cookfulness created a series of five videos telling his story and providing cooking demonstrations.
2. Consumers provided feedback on the draft videos (via a 1-hour Zoom workshop and/or written feedback) with guiding questions for feedback.
3. Research team prioritised consumer feedback and gathered expert nutritionist/dietitian feedback to assist Mr Cookfulness to create a summary video to be evaluated in the current study.

Each video will be embedded into an online survey platform (Qualtrics). Individual participants will view the video within their own online browser (e.g., using a desktop computer, tablet, or smartphone). Participants will be able to watch the video as many times as they would like before proceeding to the post-video questionnaires, and the video will also be available for review while participants complete the post-video questionnaires.

To assess intervention adherence, participants will be asked if they watched the entire video at least once before completing the post-video questionnaires.
Intervention code [1] 329903 0
Behaviour
Comparator / control treatment
We will compare our newly co-designed videos with currently publicly available, standard informational video about osteoarthritis and weight loss/management (scientific and statistical facts presented by osteoarthritis experts). The video was created by Arthritis Australia (MyJointPain.org.au) and can be accessed via this link: https://youtu.be/D1wtFPZcjEY

Arm 4: Standard informational video (1 minute, 51 seconds).
Control group
Active

Outcomes
Primary outcome [1] 339873 0
Diet-related intention
Timepoint [1] 339873 0
Baseline, immediately post-video
Secondary outcome [1] 441714 0
Diet-related motivation
Timepoint [1] 441714 0
Baseline, immediately post-video
Secondary outcome [2] 441715 0
Diet-related perceived behavioural control
Timepoint [2] 441715 0
Baseline, immediately post-video
Secondary outcome [3] 441716 0
Diet-related implementation planning
Timepoint [3] 441716 0
Baseline, immediately post-video
Secondary outcome [4] 441717 0
Diet-related confidence/self-efficacy
Timepoint [4] 441717 0
Baseline, immediately post-video
Secondary outcome [5] 441718 0
Beliefs about diet and osteoarthritis
Timepoint [5] 441718 0
Baseline, immediately post-video
Secondary outcome [6] 441719 0
Willingness to engage with further recommended resources
Timepoint [6] 441719 0
Immediately post-video
Secondary outcome [7] 441720 0
Engagement with further recommended resources
Timepoint [7] 441720 0
At the conclusion of the intervention period
Secondary outcome [8] 441721 0
Video feedback
Timepoint [8] 441721 0
Immediately post-video
Secondary outcome [9] 441724 0
Feedback on the further recommended resources
Timepoint [9] 441724 0
Immediately post-video

Eligibility
Key inclusion criteria
• Adults aged 45 years and over.
• Live in Australia.
• Self-reported osteoarthritis of the hip, knee, ankle, or foot.
• Access to a computer with internet access.
• Normal or corrected to normal vision.
• Ability to write, read, and listen in English.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Self-rated as having an ‘excellent’ overall diet using the Self-Rated Diet Quality Single-Item.

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)
Allocation will be concealed using central randomisation by computer, via an automated electronic survey system (Qualtrics) that will be password-protected. Participants will complete a brief questionnaire to determine their eligibility, and if they are eligible, the Qualtrics randomisation feature will immediately and automatically randomise them to one of the four conditions using a 1:1:1:1 allocation ratio (‘evenly present elements’). Thus, the Qualtrics survey system will determine participant eligibility, and the research team will be unaware, when this decision is made, to which group the participant will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated using a 1:1:1:1 allocation ratio using a computer-generated sequence via Qualtrics (‘evenly present elements’ feature).
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
Prior to statistical analysis, normality of data will be evaluated using visual inspection (histograms, QQ-plots of residuals), and consideration of the Shapiro-Wilk statistic. If the data are not normally distributed, data transformation and re-evaluation of normality will be undertaken. If still not normally distributed, non-parametric analyses will be undertaken. Descriptive statistics and syntheses will be used to present demographic information and outcome data.

Primary analysis:
Repeated measures ANOVAs (or non-parametric Friedman tests) will evaluate main and interaction effects on diet-related intentions for 1) the new videos paired together versus the control video, 2) the contemporary informational animation alone versus the control video, and 3) the narrative storytelling video alone versus the control video. To account for the three comparisons, the significance level will be p<0.0167.

Secondary analyses:
Repeated measures ANOVAs (or non-parametric Friedman tests) will evaluate the main and interaction effects of four conditions diet-related motivation, perceived behavioural control, implementation planning, confidence/self-efficacy, and beliefs about diet and OA, and post-hoc pairwise comparisons will explore between-group effects. Given that we developed bespoke questionnaires, each questionnaire item will be analysed individually. Pearson’s Chi-Squared tests will assess between-group differences in willingness to engage with further recommended resources, and descriptive statistics will summarise each group’s actual engagement with further resources (e.g., group-specific count data for website link clicks and resource views/downloads). For statistical tests, the significance level will be p<0.05.

Exploratory analysis:
To explore additive effects of the new videos when they are paired together, a repeated measures ANOVA (or non-parametric Friedman test) will evaluate the main and interaction effects of the three conditions involving the new videos on the primary outcome (diet-related intentions). Post-hoc pairwise comparisons will explore between-group effects. The significance level will be p<0.05.

General feedback on videos and further resources:
Descriptive statistics (e.g., means, SDs, percentages, frequencies) will be used to summarise responses to ‘Yes/No’ questions and Likert ratings, and Pearson’s Chi-Squared and Kruskal-Wallis tests will explore group differences. Content analysis and word clouds will be used to summarise responses to open-ended questions. For statistical tests, the significance level will be p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/12/2024
Actual
Date of last participant enrolment
Anticipated
5/11/2025
Actual
Date of last data collection
Anticipated
5/11/2025
Actual
Sample size
Target
344
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317773 0
Charities/Societies/Foundations
Name [1] 317773 0
The Hospital Research Foundation - Arthritis
Country [1] 317773 0
Australia
Funding source category [2] 317778 0
University
Name [2] 317778 0
University of South Australia Research Investment Grant (Allied health and Human Performance)
Country [2] 317778 0
Australia
Funding source category [3] 317815 0
University
Name [3] 317815 0
University of South Australia/SA Health Allied Health Collaborative Research Grant
Country [3] 317815 0
Australia
Primary sponsor type
Individual
Name
Dr Felicity Braithwaite, University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 320089 0
None
Name [1] 320089 0
Address [1] 320089 0
Country [1] 320089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316460 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 316460 0
Ethics committee country [1] 316460 0
Australia
Date submitted for ethics approval [1] 316460 0
09/12/2022
Approval date [1] 316460 0
23/01/2023
Ethics approval number [1] 316460 0

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

Contacts
Principal investigator
Name 137958 0
Dr Felicity Braithwaite
Address 137958 0
South Australian Health and Medical Institute (SAHMRI), North Terrace, Adelaide SA, 5000
Country 137958 0
Australia
Phone 137958 0
+61 405803820
Fax 137958 0
Email 137958 0
felicity.braithwaite@gmail.com
Contact person for public queries
Name 137959 0
Felicity Braithwaite
Address 137959 0
South Australian Health and Medical Institute (SAHMRI), North Terrace, Adelaide SA, 5000
Country 137959 0
Australia
Phone 137959 0
+61 405803820
Fax 137959 0
Email 137959 0
felicity.braithwaite@gmail.com
Contact person for scientific queries
Name 137960 0
Felicity Braithwaite
Address 137960 0
South Australian Health and Medical Institute (SAHMRI), North Terrace, Adelaide SA, 5000
Country 137960 0
Australia
Phone 137960 0
+61 405803820
Fax 137960 0
Email 137960 0
felicity.braithwaite@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable data will be shared upon reasonable request.
When will data be available (start and end dates)?
Non-identifiable data will be available indefinitely from study completion.
Available to whom?
Researchers upon reasonable request (i.e., at the discretion of the principal investigator).
Available for what types of analyses?
Secondary analyses.
How or where can data be obtained?
Contact the principal investigator (Dr Felicity Braithwaite, Felicity.braithwaite@gmail.com)


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.