Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT05482802
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2022-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Exploration of an Active Training Tool to Reduce Weight Bias Among Students Pursuing a Healthcare-related Degree
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079322', 'term': 'Weight Prejudice'}], 'ancestors': [{'id': 'D011287', 'term': 'Prejudice'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2022-07-27', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Demographics', 'timeFrame': 'At baseline', 'description': 'Questions regarding age, gender, occupation, marital status, religious affiliation, department of studies.'}, {'measure': 'Body perception', 'timeFrame': 'At baseline', 'description': "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."}, {'measure': 'Weight perception', 'timeFrame': 'At baseline', 'description': 'Questions regarding self-definition of weight status, the importance of weight to self-confidence, and much control a person has over the weight.'}, {'measure': 'Weight history', 'timeFrame': 'At baseline', 'description': '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.'}, {'measure': 'Objective weight measurement', 'timeFrame': 'At baseline', 'description': 'Measurement of actual weight in kilograms.'}, {'measure': 'Objective height measurement', 'timeFrame': 'At baseline', 'description': 'Measurement of actual height in meters.'}, {'measure': 'Semi structured interviews', 'timeFrame': 'At six- weeks post-intervention', 'description': "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."}], 'primaryOutcomes': [{'measure': "Anti-Fat Attitudes questionnaire ('AFA')", 'timeFrame': 'Change from baseline at six- weeks post-intervention', 'description': "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."}, {'measure': "The short-form of fat-phobia scale (' F-scale')", 'timeFrame': 'Change from baseline at six- weeks post-intervention', 'description': "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."}, {'measure': "Weight Implicit Association Test ('IAT')", 'timeFrame': 'Change from baseline at six- weeks post-intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Knowledge about obesity', 'timeFrame': 'Change from baseline at six- weeks post-intervention', 'description': 'Knowledge about obesity will be assessed by five questions that were written by the research team according to current literature.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity Bias']}, 'referencesModule': {'references': [{'pmid': '38184475', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergraduate students pursuing a healthcare-related degree including nutrition science, health systems management, communication disorders, physiotherapy, occupational therapy, and nursing at Ariel university\n* age ≥18 years\n* willingness to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05482802', 'briefTitle': 'The Exploration of an Active Training Tool to Reduce Weight Bias Among Students Pursuing a Healthcare-related Degree', 'organization': {'class': 'OTHER', 'fullName': 'Ariel University'}, 'officialTitle': 'The Exploration of an Active Training Tool to Reduce Weight Bias Among Students Pursuing a Healthcare-related Degree', 'orgStudyIdInfo': {'id': 'AU-HEA-SSD-20220709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'An active training tool on weight bias and knowledge about obesity', 'description': '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.', 'interventionNames': ['Behavioral: An active training tool on weight bias and knowledge about obesity']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'A short-written document on obesity', 'description': 'A short-written document on obesity which will be based on current literature.', 'interventionNames': ['Behavioral: A short-written document on obesity']}], 'interventions': [{'name': 'An active training tool on weight bias and knowledge about obesity', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['An active training tool on weight bias and knowledge about obesity']}, {'name': 'A short-written document on obesity', 'type': 'BEHAVIORAL', 'description': 'A short-written document on obesity which will be based on current literature.', 'armGroupLabels': ['A short-written document on obesity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40700', 'city': 'Ariel', 'country': 'Israel', 'facility': 'Ariel University', 'geoPoint': {'lat': 32.1065, 'lon': 35.18449}}], 'overallOfficials': [{'name': 'Shiri Sherf-Dagan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ariel university and Assuta medical center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ariel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Shiri Sherf Dagan', 'investigatorAffiliation': 'Ariel University'}}}}