Obesity BiasNCT05482802
The Exploration of an Active Training Tool to Reduce Weight Bias Among Students Pursuing a Healthcare-related Degree
A study testing An active training tool on weight bias and knowledge about obesity and A short-written document on obesity in people with Obesity Bias, run by Ariel University at 1 site in Israel.
Trial summary
An open-label parallel RCT will be conducted among 220 students pursuing a health-related degree at Ariel university. The intervention tool will be based on the constructive social learning model and will include a short lecture on obesity, scenarios simulating a meeting between health professionals and patients with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity Bias
- What is being tested?
- An active training tool on weight bias and knowledge about obesity and A short-written document on obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergraduate students pursuing a healthcare-related degree including nutrition science, health systems management, communication disorders, physiotherapy, occupational therapy, and nursing at Ariel university
- age ≥18 years
- willingness to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
An open-label parallel RCT will be conducted among 220 students pursuing a health-related degree at Ariel university. The intervention tool will be based on the constructive social learning model and will include a short lecture on obesity, scenarios simulating a meeting between health professionals and patients with obesity that will be presented by professional role-players and include varying degrees of weight bias, stigma and discrimination, and an open discourse with a patient with obesity. The tool's development will be carried out throughout recommended steps including a comprehensive literature review, preparation of a preliminary draft of the plan, evaluation of the planned intervention tool in terms of content validity, and a pilot testing of the tool among n=15 students from the target population.
The control group will receive a short-written document on obesity. This study will utilize an embedded mixed-method approach. At baseline, one- and six- weeks post-intervention both groups will be asked to fill an anonymous online survey which will include demographics, weight and body perception, knowledge about obesity, the Anti-Fat Attitudes questionnaire, the Short-Form of Fat-Phobia scale, and the Weight-Implicit Association-Test. Moreover, in-depth interviews will be conducted among 15 participants from each group.
- Conditions
- Obesity Bias
- Being tested
- An active training tool on weight bias and knowledge about obesity, A short-written document on obesity
- Medical subject headings
- Weight Prejudice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An active training tool on weight bias and knowledge about obesityBehavioural
The intervention will take place at the university simulation center and include three components. First, a short lecture on obesity and weight bias. Second, four scenarios that simulate meetings between health professionals and people with obesity which will be presented by professional role-players in sequence. Each scenario will include a different therapeutic situation and include varying degrees of weight bias, stigma, and discrimination to stimulate students to think and react. Third, an active open discourse with a person with obesity will be held.
A short-written document on obesityBehavioural
A short-written document on obesity which will be based on current literature.
| Study group | Role | What they receive |
|---|---|---|
| An active training tool on weight bias and knowledge about obesity | Active comparator | The intervention will take place at the university simulation center and include three components. First, a short-lecture on obesity and weight bias. Second, four scenarios that simulate meetings between health professionals and people with obesity which will be presented by professional role-players in sequence. Each scenario will include a different therapeutic situation and include varying degrees of weight bias, stigma, and discrimination to stimulate students to think and react. Third, an active open discourse with a person with obesity will be held. Receives: Behavioral: An active training tool on weight bias and knowledge about obesity |
| A short-written document on obesity | Placebo comparator | A short-written document on obesity which will be based on current literature. Receives: Behavioral: A short-written document on obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Fat Attitudes questionnaire ('AFA')
The 'AFA' indicates explicit anti-fat attitudes toward people with obesity and is composed of 13-items rated on a 10-point Likert scale and divided into three subscales ('dislike', 'fear about fat' and 'willpower'), with higher total scores indicating stronger anti-fat attitudes.
Measured: Change from baseline at six- weeks post-intervention
The short-form of fat-phobia scale (' F-scale')
The 'F-scale' indicates fat-phobic attitudes toward people with obesity and is composed of 14-pairs of adjectives that are used to describe people with obesity (e.g., 'no willpower' vs. 'has willpower') and ranked on a 1-5 scale according to the point closest to the adjective name that describes their feelings and beliefs. Higher scores indicate stronger fat-phobic attitudes.
Measured: Change from baseline at six- weeks post-intervention
Weight Implicit Association Test ('IAT')
IAT tool is an indirect measure of implicit bias toward weight which uses the constructs of "fat people" versus "thin people" and the polarized attitudes of "good" and "bad" to detect implicit weight bias.
Measured: Change from baseline at six- weeks post-intervention
Secondary outcomes (1)
Knowledge about obesity
Knowledge about obesity will be assessed by five questions that were written by the research team according to current literature.
Measured: Change from baseline at six- weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Mar 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity BiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiri Sherf Dagan, Ariel University
- Investigators
- Shiri Sherf-Dagan, PhD, Principal investigator, Ariel university and Assuta medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482802
- Sponsor's protocol ID
- AU-HEA-SSD-20220709
- Status last verified
- Dec 2023
- First submitted
- 27 Jul 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sherf-Dagan S, Ofri L, Tayar I, Keisar I, Buch A, Paska-Davis N, Pinus M, Tesler R, Elran-Barak R, Boaz M, Green G. A multifaceted training tool to reduce weight bias among healthcare students: A randomized controlled trial. Obes Res Clin Pract. 2024 Jan-Feb;18(1):35-42. doi: 10.1016/j.orcp.2023.12.002. Epub 2024 Jan 5.
PubMed 38184475
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploration of an Active Training Tool to Reduce Weight Bias Among Students Pursuing a Healthcare-related Degree
- ClinicalTrials.gov ID
- NCT05482802
- Acronym / sponsor ID
- AU-HEA-SSD-20220709
- Conditions
- Obesity Bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label parallel RCT will be conducted among 220 students pursuing a health-related degree at Ariel university. The intervention tool will be based on the constructive social learning model and will include a short lecture on obesity, scenarios simulating a meeting between health professionals and patients with obesity that will be presented by professional role-players and include varying degrees of weight bias, stigma and discrimination, and an open discourse with a patient with obesity. The tool's development will be carried out throughout recommended steps including a comprehensive literature review, preparation of a preliminary draft of the plan, evaluation of the planned intervention tool in terms of content validity, and a pilot testing of the tool among n=15 students from the target population.
The control group will receive a short-written document on obesity. This study will utilize an embedded mixed-method approach. At baseline, one- and six- weeks post-intervention both groups will be asked to fill an anonymous online survey which will include demographics, weight and body perception, knowledge about obesity, the Anti-Fat Attitudes questionnaire, the Short-Form of Fat-Phobia scale, and the Weight-Implicit Association-Test. Moreover, in-depth interviews will be conducted among 15 participants from each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| An active training tool on weight bias and knowledge about obesity | Active comparator | Behavioral: An active training tool on weight bias and knowledge about obesityThe intervention will take place at the university simulation center and include three components. First, a short-lecture on obesity and weight bias. Second, four scenarios that simulate meetings between health professionals and people with obesity which will be presented by professional role-players in sequence. Each scenario will include a different therapeutic situation and include varying degrees of weight bias, stigma, and discrimination to stimulate students to think and react. Third, an active open discourse with a person with obesity will be held. |
| A short-written document on obesity | Placebo comparator | Behavioral: A short-written document on obesityA short-written document on obesity which will be based on current literature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergraduate students pursuing a healthcare-related degree including nutrition science, health systems management, communication disorders, physiotherapy, occupational therapy, and nursing at Ariel university
- age ≥18 years
- willingness to participate in the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An active training tool on weight bias and knowledge about obesityThe intervention will take place at the university simulation center and include three components. First, a short lecture on obesity and weight bias. Second, four scenarios that simulate meetings between health professionals and people with obesity which will be presented by professional role-players in sequence. Each scenario will include a different therapeutic situation and include varying degrees of weight bias, stigma, and discrimination to stimulate students to think and react. Third, an active open discourse with a person with obesity will be held. | Behavioural | An active training tool on weight bias and knowledge about obesity |
| A short-written document on obesityA short-written document on obesity which will be based on current literature. | Behavioural | A short-written document on obesity |
Primary outcome
Anti-Fat Attitudes questionnaire ('AFA')
Time frame: Change from baseline at six- weeks post-intervention
The 'AFA' indicates explicit anti-fat attitudes toward people with obesity and is composed of 13-items rated on a 10-point Likert scale and divided into three subscales ('dislike', 'fear about fat' and 'willpower'), with higher total scores indicating stronger anti-fat attitudes.
The short-form of fat-phobia scale (' F-scale')
Time frame: Change from baseline at six- weeks post-intervention
The 'F-scale' indicates fat-phobic attitudes toward people with obesity and is composed of 14-pairs of adjectives that are used to describe people with obesity (e.g., 'no willpower' vs. 'has willpower') and ranked on a 1-5 scale according to the point closest to the adjective name that describes their feelings and beliefs. Higher scores indicate stronger fat-phobic attitudes.
Weight Implicit Association Test ('IAT')
Time frame: Change from baseline at six- weeks post-intervention
IAT tool is an indirect measure of implicit bias toward weight which uses the constructs of "fat people" versus "thin people" and the polarized attitudes of "good" and "bad" to detect implicit weight bias.
1 secondary outcome
Knowledge about obesity
Time frame: Change from baseline at six- weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Derived from this study: PubMed 38184475Sherf-Dagan S, Ofri L, Tayar I, Keisar I, Buch A, Paska-Davis N, Pinus M, Tesler R, Elran-Barak R, Boaz M, Green G. A multifaceted training tool to reduce weight bias among healthcare students: A randomized controlled trial. Obes Res Clin Pract. 2024 Jan-Feb;18(1):35-42. doi: 10.1016/j.orcp.2023.12.002. Epub 2024 Jan 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiri Sherf-Dagan, PhD principal investigator
Ariel university and Assuta medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An active training tool on weight bias and knowledge about obesity and A short-written document on obesity in people with Obesity Bias, run by Ariel University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Fat Attitudes questionnaire ('AFA') (time frame: Change from baseline at six- weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05482802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.