- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06192537
Examining the Effect of Role-playing Exercise by Utilizing an Obesity Suit in a Simulation Scenario on Weight Bias and Empathy Levels Among Nutrition Sciences Students
December 21, 2023 updated by: Shiri Sherf Dagan, Ariel University
A quasi-experimental design (i.e., "One-Group Pretest-Posttest Design") will be applied among 40 convenient samples of undergraduate students in their first year of nutrition sciences program at Ariel University and Tel-Hai College.
The intervention will take place at the simulation centers of the institutions.
All participants will be asked to wear an obesity simulation suit (Unisex obesity Simulation suit, Erler-Zimmer, Germany) and to participate in a standardized scenario that simulates meetings between a person with obesity and a 'registered dietitian'.
The 'registered dietitian' will be presented by a professional role-player and the scenario will encompass different levels of weight bias.
At baseline, 1- and 3-week post-intervention both groups will be asked to fill in a survey using "Qualtrics" software.
The survey will include the Anti-Fat Attitudes questionnaire (AFA), the Short-Form of Fat-Phobia scale (F-scale), the Weight-Implicit Association-Test (weight-IAT), and the Jefferson Scale of Empathy.
Data on demographics, weight history, and perception, measurement of actual weight and height, and the beliefs about the causes of obesity questionnaire will be collected at baseline.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ariel, Israel, 40700
- Ariel University
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Contact:
- Shiri Sherf-Dagan, PhD
- Phone Number: +972525122203
- Email: shiris@ariel.ac.il
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- undergraduate students in their first year of the nutrition sciences program at Ariel University or Tel-Hai College
- age ≥18 years
- having fluency in Hebrew
- ability to wear an obesity suit
- willingness to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
All participants will be asked to wear an obesity simulation suit (Unisex obesity Simulation suit, Erler-Zimmer, Germany) and to participate in a standardized scenario that simulates meetings between a person with obesity and a 'registered dietitian'.
The 'registered dietitian' will be presented by a professional role-player and the scenario will encompass different levels of weight bias through dialogue and the use of inappropriate equipment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-Fat Attitudes questionnaire ('AFA')
Time Frame: Change from baseline at three- 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.
|
Change from baseline at three- weeks post-intervention
|
The short-form of fat-phobia scale (' F-scale')
Time Frame: Change from baseline at three- 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.
|
Change from baseline at three- weeks post-intervention
|
Weight Implicit Association Test ('IAT')
Time Frame: Change from baseline at three- 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.
|
Change from baseline at three- weeks post-intervention
|
The Jefferson Scale of Empathy (S-version)
Time Frame: Change from baseline at three- weeks post-intervention
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A 20-item scale that is designed to measure empathy in medical students.
|
Change from baseline at three- weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight perception
Time Frame: At baseline
|
Questions regarding self-definition of weight status, the importance of weight to self-confidence, and much control a person has over the weight.
|
At baseline
|
Objective weight measurement
Time Frame: At baseline
|
Measurement of actual weight in kilograms.
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At baseline
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Objective height measurement
Time Frame: At baseline
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Measurement of actual height in meters.
|
At baseline
|
Demographics
Time Frame: At baseline
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Questions regarding age, gender, occupation, marital status, and religious affiliation.
|
At baseline
|
Weight history
Time Frame: At baseline
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Questions regarding obesity during childhood, obesity during last decade, family members who struggle with obesity, currently in any process of losing weight.
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At baseline
|
The beliefs about the causes of obesity questionnaire
Time Frame: At baseline
|
Rating the importance of 20 factors contributing to obesity by using a 5-point Likert-scale response format.
|
At baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
December 21, 2023
First Submitted That Met QC Criteria
December 21, 2023
First Posted (Actual)
January 5, 2024
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
December 21, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU-HEA-SS-20231016-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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