NCT05482802

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

July 27, 2022

Last Update Submit

December 21, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Change from baseline at six- weeks post-intervention

Secondary Outcomes (1)

  • Knowledge about obesity

    Change from baseline at six- weeks post-intervention

Other Outcomes (7)

  • Demographics

    At baseline

  • Body perception

    At baseline

  • Weight perception

    At baseline

  • +4 more other outcomes

Study Arms (2)

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.

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.

Behavioral: A short-written document on obesity

Interventions

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.

An active training tool on weight bias and knowledge about obesity

A short-written document on obesity which will be based on current literature.

A short-written document on obesity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ariel University

Ariel, 40700, Israel

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Weight Prejudice

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehavior

Study Officials

  • Shiri Sherf-Dagan, PhD

    Ariel university and Assuta medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 27, 2022

First Posted

August 1, 2022

Study Start

March 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

December 22, 2023

Record last verified: 2023-12

Locations