- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05482802
The Exploration of an Active Training Tool to Reduce Weight Bias Among Students Pursuing a Healthcare-related Degree
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ariel, Israel, 40700
- Ariel University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: An active training tool on weight bias and knowledge about obesity
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.
|
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.
|
|
Placebo Comparator: A short-written document on obesity
A short-written document on obesity which will be based on current literature.
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A short-written document on obesity which will be based on current literature.
|
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 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.
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Change from baseline at six- weeks post-intervention
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The short-form of fat-phobia scale (' F-scale')
Time Frame: Change from baseline at six- weeks post-intervention
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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.
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Change from baseline at six- weeks post-intervention
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|
Weight Implicit Association Test ('IAT')
Time Frame: Change from baseline at six- weeks post-intervention
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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.
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Change from baseline at six- weeks post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge about obesity
Time Frame: Change from baseline at six- weeks post-intervention
|
Knowledge about obesity will be assessed by five questions that were written by the research team according to current literature.
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Change from baseline at six- weeks post-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographics
Time Frame: At baseline
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Questions regarding age, gender, occupation, marital status, religious affiliation, department of studies.
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At baseline
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Body perception
Time Frame: At baseline
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Body Appreciation Scale-2 is a 10-item scale which ranked on a 1-5 scale and assesses acceptance and/or favorable opinions towards a person's body.
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At baseline
|
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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.
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At baseline
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Weight history
Time Frame: At baseline
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Questions regarding current weight and height, 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
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Objective weight measurement
Time Frame: At baseline
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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.
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At baseline
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Semi structured interviews
Time Frame: At six- weeks post-intervention
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Fifteen participants from each study group will be randomly chosen for conducting a semi-structured interviews.
The interviews will take place six weeks post-intervention and will provide in-depth, detailed information regarding the participants' views of obesity and stigma after conducting the intervention.
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At six- weeks post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shiri Sherf-Dagan, PhD, Ariel university and Assuta medical center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AU-HEA-SSD-20220709
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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