Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001351606p
Ethics application status
Submitted, not yet approved
Date submitted
17/11/2023
Date registered
21/12/2023
Date last updated
21/12/2023
Date data sharing statement initially provided
21/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Weight bias in Australian healthcare students: Examining the effectiveness of an empathy vs science approach to stigma response
Scientific title
Examining whether a video about empathy or the multifactorial causes of obesity is efficacious in addressing weight bias among Australian healthcare students.
Secondary ID [1] 310980 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight stigma 332065 0
Obesity stigma 332068 0
Condition category
Condition code
Public Health 328803 328803 0 0
Health service research
Diet and Nutrition 329023 329023 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthcare students recruited from universities around Australia will be randomly assigned to watch one of two intervention videos. The intervention will take place online, implemented via Qualtrics. Participants will be able to take part in the intervention at a place and time of their choosing.

The two videos are:

1) Empathy: this video is 10 minutes long and is about an individual living with obesity. The video describes the individual's lifestyle habits (including diet and physical activity), weight loss, weight stigma experienced in healthcare, and participation in an organisation designed to end (and research) weight stigma. The video also shows how multiple practising healthcare professionals converse with the individual living with obesity on how they can approach patients living with overweight or obesity and treat them respectfully and impartially. Overall, this video is designed to induce empathy for people living with overweight or obesity.

2) Multifactorial causes of obesity: this video is animated and is 10 minutes in length. The video describes appetite, diet, metabolism, epigenetic and genetic influences of obesity, environmental and social influences of obesity, dietary habits of human ancestors, complications of obesity, and treatments for obesity. Overall, this video is designed to provide education about the multifactorial causes of obesity.

The two videos will be viewed by participants once: following the completion of baseline outcome measures (design: baseline measures > videos > immediate post-intervention measures > 2 WEEK PERIOD > follow-up outcome measures).

These videos have been developed by The Obesity Collective, the peak body for obesity in Australia. These videos are not yet available to the public. The videos will be embedded in Qualtrics, and participants will be able to view them as they complete the study. Monitoring the adherence to the intervention is not the primary goal of the study; however, will be monitored by the number of participants who complete the entire study vs. the number of participants who drop out.

Who will conduct the intervention: 4th-year PhD student Ravisha J will conduct the intervention. Ravisha has 5 years of experience in conducting psychological research.
Intervention code [1] 327416 0
Lifestyle
Intervention code [2] 327417 0
Behaviour
Comparator / control treatment
One-third of the recruited healthcare students will also be randomly assigned to the active control condition. The control condition will involve students watching a video about smoking (a topic unrelated to obesity stigma). This video will be 10 minutes in length, and will include information such as why people smoke, risk factors for smoking, complications of smoking and treatments for smoking. The video will be compiled using relevant videos from YouTube or will be obtained from an organisation that has developed a video with the above information.

The video will be viewed by participants once: following the completion of baseline outcome measures (design: baseline measures > video > immediate post-intervention measures > 2 WEEK PERIOD > follow-up outcome measures).

This video will be designed specifically for this study; however, by using (combining) existing videos on YouTube (e.g., How do cigarettes affect the body? by Krishna Sudhir - TED-ED, Sep 13, 2018). The video will be embedded in Qualtrics, and participants will be able to view it as they complete the study. Monitoring the adherence to the intervention is not the primary goal of the study; however, will be monitored by the number of participants who complete the entire study vs. the number of participants who drop out.

All other details described above (description of intervention/exposure) also apply to this section.
Control group
Active

Outcomes
Primary outcome [1] 336829 0
Attitudes towards people living with overweight and obesity - Dislike
Timepoint [1] 336829 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Primary outcome [2] 336830 0
Attitudes towards people living with overweight and obesity - Fear of Fat
Timepoint [2] 336830 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Primary outcome [3] 336831 0
Attitudes towards people living with overweight and obesity - Willpower
Timepoint [3] 336831 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [1] 429759 0
Beliefs about the controllability of weight. Note that this is also a primary outcome.
Timepoint [1] 429759 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [2] 429760 0
Empathy towards people living with overweight or obesity - validated measure. Note that this is also a primary outcome.
Timepoint [2] 429760 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [3] 429761 0
Confidence in interacting clinically with people living with overweight or obesity - validated measure. Note that this is also a primary outcome.
Timepoint [3] 429761 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [4] 429762 0
Attitudes towards people living with overweight or obesity - Activism Orientation. Note that this is also a primary outcome
Timepoint [4] 429762 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [5] 429763 0
Attitudes towards people living with overweight or obesity - Size Acceptance. Note that this is also a primary outcome
Timepoint [5] 429763 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [6] 429764 0
Attitudes towards people living with overweight or obesity - Critical Health. Note that this is also a primary outcome
Timepoint [6] 429764 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [7] 429765 0
Attitudes towards people living with overweight or obesity - Socioeconomic Complexity. Note that this is also a primary outcome.
Timepoint [7] 429765 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [8] 429766 0
Perceptions of obesity. Note that this is also a primary outcome
Timepoint [8] 429766 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [9] 429767 0
Socially desirable responding. Note that this is also a primary outcome.
Timepoint [9] 429767 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up.
Secondary outcome [10] 429768 0
Influential parts of the intervention
Timepoint [10] 429768 0
Immediately post-intervention
Secondary outcome [11] 430113 0
Empathy - Perspective taking
Timepoint [11] 430113 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [12] 430114 0
Empathy - Empathic Concern
Timepoint [12] 430114 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up
Secondary outcome [13] 430115 0
Empathy - Personal distress
Timepoint [13] 430115 0
Baseline, immediately post-intervention (primary timepoint), and 2 week follow-up

Eligibility
Key inclusion criteria
Individuals will be eligible to participate in this study if they are currently enrolled (as at February 2024) in a healthcare course at an Australian tertiary institution either at the undergraduate or postgraduate level. Students from healthcare courses including (but not limited to) medicine, paramedicine, medical imaging, dentistry, oral health therapy, nursing, midwifery, dietetics, nutrition, psychology, counselling, social work, physiotherapy, occupational therapy, speech pathology, chiropractic, exercise science, audiology, optometry, public health/health promotion, and pharmacology are eligible to participate.

Additional inclusion criteria are for students to be at least 17 years of age, able to understand and write in English, able to provide informed consent to participate, and have normal or corrected to normal vision.
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include university students enrolled in non-healthcare courses (e.g., business), practising healthcare professionals (e.g., registered dietitians, practising GPs) and students who are unable to view short videos (e.g., animations) due to a health condition.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The online survey hosting platform Qualtrics will automatically and randomly allocate participants to the intervention or control conditions. The investigator will be blind to the random allocation process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An A-Priori sample size calculation was conducted via GLIMMPSE (Kreidler et al., 2013) for General Linear Mixed Models. With a target power of 0.8, a type I error rate of 0.05, the software indicated that a total of 27 participants (9 for each group (empathy video, video about the uncontrollable causes of obesity, and control)). However, the average sample size of previous weight bias reduction studies is 112 participants. Additionally, to account for attrition, significantly more participants will be recruited. Taking into account the previous sample sizes and attrition, it is anticipated that around 30 participants will be recruited for each condition, with a total sample size of 90.

Brief data analysis plan: all data will be analysed using SPSS statistics. Initially, descriptive statistics will be calculated to describe the sample (e.g., mean age, number of participants in each healthcare course). Then, General Linear Mixed Models (random effects) will be employed to determine the efficacy of the weight bias intervention (immediate post-test) and whether changes are sustained in the long-term (2-week follow-up).

Using the responses to the open-ended question, a thematic or content analysis (qualitative data analysis method) will be employed to explore the intervention components that were the most impactful for students.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2024
Actual
Date of last participant enrolment
Anticipated
14/03/2024
Actual
Date of last data collection
Anticipated
28/03/2024
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315215 0
Government body
Name [1] 315215 0
Australian Government, Department of Education - The Research Training Program (RTP) . The funding source has funded the entire PhD project and had no input in individual study design/implementation.
Country [1] 315215 0
Australia
Primary sponsor type
Individual
Name
Ravisha S. Jayawickrama
Address
Curtin University, Kent Street, Bentley, WA 6102
Country
Australia
Secondary sponsor category [1] 317245 0
Individual
Name [1] 317245 0
Dr Blake Lawrence - primary project supervisor
Address [1] 317245 0
Curtin University, Kent Street, Bentley, WA 6102
Country [1] 317245 0
Australia
Secondary sponsor category [2] 317282 0
Individual
Name [2] 317282 0
Dr Briony Hill - primary project supervisor
Address [2] 317282 0
Monash University, Wellington Road, Clayton, VIC 3800
Country [2] 317282 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314139 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 314139 0
Ethics committee country [1] 314139 0
Australia
Date submitted for ethics approval [1] 314139 0
23/11/2023
Approval date [1] 314139 0
Ethics approval number [1] 314139 0

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

Contacts
Principal investigator
Name 130554 0
Miss Ravisha S. Jayawickrama
Address 130554 0
Curtin University, Kent Street, Bentley, WA 6102
Country 130554 0
Australia
Phone 130554 0
+61 413 384 257
Fax 130554 0
Email 130554 0
[email protected]
Contact person for public queries
Name 130555 0
Ravisha S. Jayawickrama
Address 130555 0
Curtin University, Kent Street, Bentley, WA 6102
Country 130555 0
Australia
Phone 130555 0
+61 413 384 257
Fax 130555 0
Email 130555 0
[email protected]
Contact person for scientific queries
Name 130556 0
Ravisha S. Jayawickrama
Address 130556 0
Curtin University, Kent Street, Bentley, WA 6102
Country 130556 0
Australia
Phone 130556 0
+61 413 384 257
Fax 130556 0
Email 130556 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
Individual participant data will not be publicly available; however, may be available upon reasonable request from an appropriate individual/organisation (e.g., researcher).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21160Informed consent form  [email protected] This document may be provided upon reasonable requ... [More Details]
21161Ethical approval  [email protected] This document may be provided upon reasonable requ... [More Details]



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.