Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-26 @ 10:24 AM
Study NCT ID:
NCT05804292
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2023-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-26', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-03-26', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binge Eating', 'timeFrame': 'Baseline', 'description': 'Score on the Binge Eating Scale. Each question has 3-4 separate responses assigned a numerical value. The score range is from 0-46: Non-binging; less than 17; Moderate binging; 18-26; Severe binging; 27 and greater'}, {'measure': 'Food Addiction', 'timeFrame': 'Baseline', 'description': 'Scored on the Modified Yale Food Addiction Scale version 2 and at the Addiction-like Eating Behavioural Scale The "symptom count" score, ranging from 0 to 7, that reflects the number of addiction-like criteria endorsed was applied'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Eating Disorders']}, 'descriptionModule': {'briefSummary': 'Obesity is a global epidemic and a major contributor to some of the leading causes of death.\n\nAlthough research on overweight and obesity is constantly increasing, to date, in the Italian panorama, there is a lack of (A) rigorous psychological measurement tools of obesity-related constructs and (B) analysis of the relationships between constructs (and indicators) involved in the development and maintenance of overweight and obesity.\n\nThe present study aims to examine the psychometric properties of the main questionnaires for the assessment of eating behaviors in 3 groups of subjects (1) the general population (control group); (2) subjects with obesity without a comorbid diagnosis of an eating disorder; (3) subjects with obesity and a comorbid diagnosis of an eating disorder.', 'detailedDescription': "Participants were selected in the main rehabilitation centers for the treatment of obesity and eating disorders (sample of subjects with obesity) and through an online survey (community sample). The survey lasted about 30 minutes and - together with selected demographic and biomedical information - required the completion of the following self-report measures: the Binge Eating Scale (BES); the Modified Yale Food Addiction Scale version 2 (mYFAS 2.0); the Repetitive eating questionnaire (Rep-EAT); the Measure of Eating Compulsivity (MEC); the Addiction-like Eating Behavioural Scale (AEBS); the Three Factor Eating Questionnaire 18 (TFEQ-18); the Eating Disorders Examination Questionnaire-Short Form (EDEQ-SF); the Palatable Eating Motive Scale (PEMS); the Weight Sigma Questionnaire (WSSQ); the Emotional Eating Scale (EES); the Somatic Symptom Scale 8 (SSS8).\n\nBefore administration, all questionnaires were first translated from English (their original language) to Italian by two bilingual translators, independently - then back-translated into English by another independent translator whose mother tongue was English to ensure equivalence between the translations. Following, a purposive sample of respondents was asked to fill in the final version of each measure in order to assess its items' comprehensibility.\n\nIn order to avoid halo effects, the questionnaires were presented to the subject in random order.\n\nThe responders could withdraw the administration at any time, and contact a psychologist independent from the study in case of perceived emotional distress."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with obesity with/without an eating disorder AND the general population (non clinical)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 30 kg/m2 (clinical sample)\n* Diagnosis of an eating disorder (clinical sample)\n* age range 18-75 years\n* Italian mother tongue\n* written and informed consent to participate\n\nExclusion Criteria:\n\n* visual impairing\n* neurological problems\n* alcohol/drug abuse'}, 'identificationModule': {'nctId': 'NCT05804292', 'acronym': 'Valid-OB', 'briefTitle': 'Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors in Persons With Obesity and the General Population in Italy.', 'orgStudyIdInfo': {'id': '03C020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Community sample', 'description': 'Questionnaires administration', 'interventionNames': ['Other: Questionnaire administration']}, {'label': 'Subjects with obesity and comorbid eating disorder', 'description': 'Questionnaires administration', 'interventionNames': ['Other: Questionnaire administration']}, {'label': 'Subjects with obesity without comorbid eating disorder', 'description': 'Questionnaires administration', 'interventionNames': ['Other: Questionnaire administration']}], 'interventions': [{'name': 'Questionnaire administration', 'type': 'OTHER', 'description': 'Questionnaire administration', 'armGroupLabels': ['Community sample', 'Subjects with obesity and comorbid eating disorder', 'Subjects with obesity without comorbid eating disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20145', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Auxologico Italiano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Giada Pietrabissa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Auxologico Italiano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}