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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
23/06/2025
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
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Scientific title
Impact of educational videos about osteoarthritis, diet, and weight management on diet-related intentions in people with osteoarthritis: a randomised online experiment
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Secondary ID [1]
313322
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
335676
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Condition category
Condition code
Public Health
332451
332451
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0
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Health promotion/education
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Musculoskeletal
332238
332238
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0
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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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 (response options: Yes / No). We will also record the amount of time each participant spends on the video viewing page of the survey to check whether or not the participant spent the full video run-time on the page.
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Intervention code [1]
329903
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Behaviour
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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).
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Control group
Active
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Outcomes
Primary outcome [1]
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Diet-related intention
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Assessment method [1]
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1 item assessed using an 11-point Numeric Rating Scale (NRS) from 0=strongly disagree to 10=strongly disagree: “In the next 3 months, I intend to make changes to my diet”
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Timepoint [1]
339873
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Baseline, immediately post-video
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Secondary outcome [1]
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Diet-related confidence/self-efficacy
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Assessment method [1]
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4 items assessed using an 11-point NRS from 0=not at all true to 10=always true: 1. "I am confident that I can find means and ways to change my diet" 2. "I am confident that I can find several solutions when I am confronted with a barrier to changing my diet" 3. "I am confident that I can eat healthily even when I am in pain" 4. "I am confident that I can eat healthily without the help of a health professional". These secondary outcomes will be assessed separately (as per the statistical analysis plan).
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Timepoint [1]
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Baseline, immediately post-video
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Secondary outcome [2]
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Feedback on the further recommended resources
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Assessment method [2]
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The bespoke website hosting the recommended resources will provide optional general feedback forms for each resource with the following questions: 1. "I found this resource to be useful" (11-point NRS from 0=strongly disagree to 10=strongly agree) 2. "What did you think about this resource?" [open text box]. These secondary outcomes will be assessed separately (as per the statistical analysis plan).
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Timepoint [2]
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Immediately post-video
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Secondary outcome [3]
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Diet-related implementation planning
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Assessment method [3]
441716
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2 items assessed using an 11-point NRS from 0=no plans to 10=detailed plans: 1. "I will make plans for ‘what’ kind of dietary changes I am going to engage in over the next 2 weeks" 2. "I will make plans for ‘how’ I am going to make changes to my diet over the next 2 weeks". These secondary outcomes will be assessed separately (as per the statistical analysis plan).
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Timepoint [3]
441716
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Baseline, immediately post-video
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Secondary outcome [4]
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Willingness to engage with further recommended resources
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Assessment method [4]
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1 item assessed using an 11-point NRS from 0=strongly disagree to 10=strongly agree: "Would further resources/information about diet and osteoarthritis be useful?"
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Timepoint [4]
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Immediately post-video
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Secondary outcome [5]
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Diet-related motivation
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Assessment method [5]
441714
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2 items assessed using 11-point NRS: 1. "I am willing to try hard to make changes to my diet over the next 2 weeks" (11-point NRS from 0=not try at all to 10=try as hard as I possibly can) 2. "I am motivated to make changes to my diet over the next 2 weeks" (11-point NRS from 0=extremely unmotivated to 10=extremely motivated). These secondary outcomes will be assessed separately (as per the statistical analysis plan).
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Timepoint [5]
441714
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Baseline, immediately post-video
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Secondary outcome [6]
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Video feedback
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Assessment method [6]
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Video feedback will be assessed using open-ended questions, Yes/No questions, and 11-point NRS scales to capture general feedback (e.g., usefulness, satisfaction with the information, relevance of the information), message content/mode preferences, and positive or negative feelings evoked (e.g., achievability, hope, shame, stigma). For the two conditions involving the narrative storytelling video, participants will also be asked questions about what they thought about the story, including feelings of validation and identification with the narrator. These secondary outcomes will be assessed separately (as per the statistical analysis plan).
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Timepoint [6]
441721
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Immediately post-video
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Secondary outcome [7]
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Diet-related perceived behavioural control
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Assessment method [7]
441715
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5 items assessed using 11-point NRS: 1. "Engaging in regular diet improvements over the next 2 weeks is under my control" (11-point NRS from 0=not at all to 10=very much) 2. "For me to eat a healthy diet in the future would be. . ." (11-point NRS from 0=very difficult to 10=very easy) 3. "I would like to eat a healthy diet but don’t really know if I can" (11-point NRS from 0=strongly disagree to 10=strongly agree) 4. "Whether I do or do not eat a healthy diet in the future is entirely up to me" (11-point NRS from 0=strongly disagree to 10=strongly agree) 5. "I am confident that if I ate a healthy diet I could keep to it" (11-point NRS from 0=strongly disagree to 10=strongly agree). These secondary outcomes will be assessed separately (as per the statistical analysis plan).
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Timepoint [7]
441715
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Baseline, immediately post-video
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Secondary outcome [8]
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Aloneness/belongingness and validation
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Assessment method [8]
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3 items assessed using an 11-point NRS from 0=strongly disagree to 10=strongly agree: 1. "I feel alone in my journey of managing my osteoarthritis pain" 2. "There are many people who have had similar experiences to me regarding diet and osteoarthritis pain" 3. "I feel supported in my journey of managing my osteoarthritis pain". These secondary outcomes will be assessed separately (as per the statistical analysis plan).
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Timepoint [8]
448914
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Baseline, immediately post-video
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Secondary outcome [9]
448915
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Expectation of improvement
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Assessment method [9]
448915
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1 item assessed using an 11-point NRS from 0=not at all to 10=extremely: "How much do you expect that your osteoarthritis pain will improve with a better diet?".
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Timepoint [9]
448915
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Baseline, immediately post-video
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Secondary outcome [10]
441718
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Beliefs about diet and osteoarthritis
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Assessment method [10]
441718
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8 items assessed using an 11-point NRS: 1. "Diet affects osteoarthritis pain" (11-point NRS from 0=strongly disagree to 10=strongly agree) 2. "A healthy diet is beneficial for osteoarthritis pain" (11-point NRS from 0=strongly disagree to 10=strongly agree) 3. "Losing or managing weight is important for osteoarthritis pain" (11-point NRS from 0=strongly disagree to 10=strongly agree) 4. "If I make changes to my diet in the next 3 months, this would be (11-point NRS from 0=harmful to 10=beneficial) for my osteoarthritis" 5. "If I make changes to my diet in the next 3 months, this would be (11-point NRS from 0=useless to 10=useful) for my osteoarthritis" 6. "If I make changes to my diet in the next 3 months, this would be (11-point NRS from 0=foolish to 10=wise) for my osteoarthritis" 7. "If I make changes to my diet in the next 3 months, this would be (11-point NRS from 0=bad to 10=good) for my osteoarthritis" 8. "If I make changes to my diet in the next 3 months, this would be (11-point NRS from 0=unpleasant to 10=pleasant)". These secondary outcomes will be assessed separately (as per the statistical analysis plan).
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Timepoint [10]
441718
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Baseline, immediately post-video
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Secondary outcome [11]
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Engagement with further recommended resources
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Assessment method [11]
441720
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Assessed using Google Analytics: Group-specific counts of link clicks to a bespoke website hosting the resources (using a group-specific URL), as well as downloads/views (Google Analytics) of each recommended resource. Only overall count data by group will be collected, because linking these data to individual participants will not be possible.
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Timepoint [11]
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At the conclusion of the intervention period
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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.
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Self-rated as having an ‘excellent’ overall diet using the Self-Rated Diet Quality Single-Item.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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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.
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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).
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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 analyses:
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 the four conditions on diet-related motivation, perceived behavioural control, implementation planning, confidence/self-efficacy, beliefs about diet and OA, aloneness/belongingness and validation, and expectation of improvement, and post-hoc pairwise comparisons will explore between-group effects. Given that we developed bespoke questionnaires, each questionnaire item will be analysed individually. One-way ANOVA (or non-parametric Kruskal-Wallis test) will assess between-group differences in beliefs about whether further resources/information would be useful, 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, including the comparative effect of the two new videos (contemporary informational animation alone versus the narrative storytelling video alone).
Planned exploratory analyses for the two conditions involving the narrative storytelling video will evaluate whether changes in primary/secondary outcomes are moderated by gender via a subgroup analysis of average change scores for matched versus unmatched gender of the participant with the narrator, Mr Cookfulness (independent t-tests or Mann-Whitney U tests). We will also explore whether changes in primary and secondary outcomes are associated with participant ratings on how much they related to the story, felt validated by the story, and identified with the narrator (Pearson’s or Spearman’s rank correlations). Last, we will use content analysis of open-ended questions to explore mentions of similarity/identifying with the narrator, and descriptive analyses to explore patterns of participant characteristics (e.g., demographics) that relate to participant identification with the narrator.
For all primary and secondary analyses, we will also perform sensitivity analyses excluding participants who report that they did not watch the entire allocated video at least once, as well as for participants who spent less time on the video viewing page of the survey than the full video run-time.
The significance level will be p<0.05 for all exploratory statistical analyses.
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 NRS ratings, and Pearson’s Chi-Squared and one-way ANOVAs (or non-parametric 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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2025
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Actual
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Date of last participant enrolment
Anticipated
5/11/2025
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Actual
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Date of last data collection
Anticipated
5/11/2025
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Actual
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Sample size
Target
344
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of South Australia/SA Health Allied Health Collaborative Research Grant
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
317773
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Charities/Societies/Foundations
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Name [2]
317773
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The Hospital Research Foundation - Arthritis
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Address [2]
317773
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Country [2]
317773
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Australia
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Funding source category [3]
317778
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University
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Name [3]
317778
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University of South Australia Research Investment Grant (Allied health and Human Performance)
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Address [3]
317778
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Country [3]
317778
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Australia
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Primary sponsor type
Individual
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Name
Dr Felicity Braithwaite, University of South Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
320089
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None
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Name [1]
320089
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Address [1]
320089
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Country [1]
320089
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of South Australia Human Research Ethics Committee
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Ethics committee address [1]
316460
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https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/
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Ethics committee country [1]
316460
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Australia
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Date submitted for ethics approval [1]
316460
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09/12/2022
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Approval date [1]
316460
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23/01/2023
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Ethics approval number [1]
316460
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Summary
Brief summary
We will undertake a randomised online study evaluating two newly co-designed brief educational videos against a publicly available control video on the topic of osteoarthritis and diet/weight management. The aim is to understand whether communication strategy surrounding diet/weight management matters to people with osteoarthritis’ diet-related outcomes, including intentions, motivation, perceived behavioural control, implementation planning, beliefs about diet and osteoarthritis, aloneness/belongingness and validation, expectation of improvement of osteoarthritis pain, and engagement with further recommended resources. We hypothesise that the new videos (paired together or alone) will lead to greater improvements in diet-related intentions than the control video.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Felicity Braithwaite
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Address
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South Australian Health and Medical Institute (SAHMRI), North Terrace, Adelaide SA, 5000
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Country
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Australia
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Phone
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+61 405803820
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Felicity Braithwaite
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Address
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South Australian Health and Medical Institute (SAHMRI), North Terrace, Adelaide SA, 5000
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Country
137959
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Australia
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Phone
137959
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+61 405803820
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Fax
137959
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Email
137959
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[email protected]
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Contact person for scientific queries
Name
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Felicity Braithwaite
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Address
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South Australian Health and Medical Institute (SAHMRI), North Terrace, Adelaide SA, 5000
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Country
137960
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Australia
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Phone
137960
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+61 405803820
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Fax
137960
0
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Email
137960
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
•
Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
•
Requires a scientifically sound proposal or protocol
•
Requires approval by an ethics committee
•
Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
All de-identified individual participant data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
Contact the principal investigator (Dr Felicity Braithwaite,
[email protected]
)
Are there extra considerations when requesting access to individual participant data?
No
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.
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