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

August 31, 2024 updated by: Shiri Sherf Dagan, Ariel University
A quasi-experimental design (i.e., "One-Group Pretest-Posttest Design") will be applied among 34 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Israel
      • Ariel, Israel, 40700
        • Ariel University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Behavioral: A role-playing exercise by utilizing an obesity suit in a simulation scenario
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
A 20-item scale that is designed to measure empathy in medical students.
Change from baseline at three- weeks post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
At baseline
Objective height measurement
Time Frame: At baseline
Measurement of actual height in meters.
At baseline
Demographics
Time Frame: At baseline
Questions regarding age, gender, occupation, marital status, and religious affiliation.
At baseline
Weight history
Time Frame: At baseline
Questions regarding obesity during childhood, obesity during last decade, family members who struggle with obesity, currently in any process of losing weight.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ariel University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tel Hai College

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

Conditions

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