Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-02 @ 9:12 AM
Study NCT ID:
NCT05149859
Status:
RECRUITING
Last Update Posted:
2024-10-09
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compuls-BED-Severity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2021-11-19', 'studyFirstSubmitQcDate': '2021-12-07', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical and psychological comorbidities', 'timeFrame': 'Inclusion', 'description': 'Number of current associated comorbidities to patient with and without BED'}, {'measure': 'Binge Eating Scale score', 'timeFrame': 'Inclusion', 'description': 'To assess binge eating severity based on the 16-item scale developed by Gormally et al in 1982'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index in kg.m-2', 'timeFrame': 'Inclusion', 'description': '\\[Anthropometric markers\\] weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Percentage of fat mass in %', 'timeFrame': 'Inclusion', 'description': '\\[Anthropometric markers\\] Based on impedance data, percentage fat mass will be reported when available'}, {'measure': 'Waist and hip circumferences in cm', 'timeFrame': 'Inclusion', 'description': '\\[Anthropometric markers\\] Waist, hip circumference and Waist-hip ratio will be reported in cm when available'}, {'measure': 'Triglycerides in mmol/L', 'timeFrame': 'Inclusion', 'description': 'Routine clinical biological markers; part of lipidic profile (when available)'}, {'measure': 'Cholesterol HDL and LDL in mmol/L', 'timeFrame': 'Inclusion', 'description': 'Routine clinical biological markers; part of lipidic profile (when available)'}, {'measure': 'Fasting blood glucose in mmol/L', 'timeFrame': 'Inclusion', 'description': 'Routine clinical biological markers, when available.'}, {'measure': 'Glycated hemoglobin (HbA1C) in %', 'timeFrame': 'Inclusion', 'description': 'Routine clinical biological markers, when available.'}, {'measure': 'Insulin in pmol/L', 'timeFrame': 'Inclusion', 'description': 'Routine clinical biological markers, when available.'}, {'measure': 'Visceral Adiposity Index', 'timeFrame': 'Inclusion', 'description': 'The Visceral Adiposity Index (VAI) is a sex-specific mathematical index, based on Waist Circumference (WC), Body Mass Index (BMI), triglycerides (TG) and HDL cholesterol (HDL) levels, indirectly expressing visceral adipose function and insulin sensitivity.'}, {'measure': 'UPPS-P Impulsive Behavior Scale short version, S-UPPS-P', 'timeFrame': 'Inclusion', 'description': 'To assess the Impulsivity-compulsivity spectrum'}, {'measure': 'Obsessive-Compulsive Inventory-Revised, OCI-R', 'timeFrame': 'Inclusion', 'description': 'To assess the Impulsivity-compulsivity spectrum'}, {'measure': 'Stop Signal Task', 'timeFrame': 'Inclusion', 'description': 'To assess the Impulsivity-compulsivity spectrum'}, {'measure': 'Difficulties in emotion regulation scale short form, DERS', 'timeFrame': 'Inclusion', 'description': 'To assess the emotion regulation spectrum'}, {'measure': 'Emotional Go / No-Go Task', 'timeFrame': 'Inclusion', 'description': 'To assess the emotion regulation spectrum'}, {'measure': 'Adult Attention Deficit Hyperactivity Disorder Self-Report Scale, ASRS', 'timeFrame': 'Inclusion', 'description': 'To assess attentional functions'}, {'measure': 'Integrated Visual and Auditory Continuous Performance Test, IVA-CPT', 'timeFrame': 'Inclusion', 'description': 'To assess attentional functions'}, {'measure': 'General Anxiety Disorder (GAD)-7', 'timeFrame': 'Inclusion', 'description': 'To assess anxiety disorders risk'}, {'measure': 'Patient Health Questionnaire (PHQ)-9', 'timeFrame': 'Inclusion', 'description': 'To assess depression disorder risk'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Binge-Eating Disorder', 'Impulsivity', 'Obesity', 'Attention', 'Emotional regulation'], 'conditions': ['Binge-Eating Disorder']}, 'descriptionModule': {'briefSummary': "* Binge Eating Disorder (BED) has been fairly recently introduced into the Diagnostic and Statistical Manual 5 psychiatric classification and its severity criteria are still not well established.\n* Moreover, it remains unclear whether BED is associated with greater metabolic severity or more somatic comorbidities, especially in obesity.\n* Improved BED severity staging could lead to a better definition of management strategies and , therefore, facilitate screening and care.\n\nThe investigators' hypothesis is that an improved assessment of the impulsivity-compulsivity spectrum, emotional regulation, attentional impairment and somatic or psychiatric comorbidities will result in a better distinction between the severe form of BED (e.g., highly impulsive and somatically complicated) from milder form (e.g., more compulsive and less somatically complicated)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients will be recruited from 2 sites: 1) the Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ; pre-bariatric surgery consultation and obesity care consultation); 2) the Centre d'Expertise Poids, Image et Alimentation (CEPIA), a clinic of the Institute of Nutrition and Functional Foods of Laval University (eatinig disorders consultation). The pre-selection of participants will be done using available data and screening tests deployed through the management frameworks already in place at the two sites. If needed, patients will be recruited by advertisement.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men or women aged 1\n* participants eligible for bariatric surgery (BMI\\>40, or BMI\\>35 with severe comorbidities)\n* participants scheduled for medical evaluation and treatment of obesity at the IUCPQ Obesity Clinic (BMI≥30)\n* participants scheduled for evaluation and treatment of BED at the CEPIA with obesity (BMI≥30)\n* for the group with BED: positive BEDS-7 screen and Binge Eating Scale score \\>16;\n* for the control group: have a negative BEDS-7 screen and Binge Eating Scale score\\<12\n* be fluent in French and able to consent.\n\nExclusion criteria :\n\n* participants with severe neurological disorder and/or major neurocognitive deficits;\n* participants with previous bariatric surgery or with introduction or change of anti-obesity medication (liraglutide or naltrexone/bupropion) in the previous 3 months;\n* participants who cannot read and/or understand French;\n* participants under guardianship or curatorship;\n* participants already included in a study with a conflict of interest with this study;\n* inability to use a computer or iPad;\n* inability to access an Internet connection or to visit one of the inclusion sites.\n\nSecondary exclusion criteria:\n\n* participants with a discordance between BEDS-7 (positive) and Binge Eating Scale (score ≤ 16) results found secondarily\n* participants who did not participate in part of the assessments (e.g., self-questionnaires or neurocognitive tests) and participants with a rate of missing data\\>10%.'}, 'identificationModule': {'nctId': 'NCT05149859', 'briefTitle': 'Compuls-BED-Severity', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Reconsidering Severity Classification for Binge Eating Disorder (BED): the Role of Impulsivity, Compulsivity and Co-occurring Disorders', 'orgStudyIdInfo': {'id': '2022-3743, 22144'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BED+ : Participants with obesity and binge eating disorder', 'description': 'Obesity is define by a BMI ≥ 30 kg.m-2 Binge eating disorder is defined by Binge Eating Disorder Screener (BEDS)-7 positive score and a Binge Eating Scale score \\>16', 'interventionNames': ['Other: Observational']}, {'label': 'BED-: Participants with obesity but without binge eating disorder', 'description': 'Obesity is define by a BMI ≥ 30 kg.m-2 Binge eating disorder is defined by Binge Eating Disorder Screener (BEDS)-7 negative score and a Binge Eating Scale score \\< 12', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': '(no intervention)', 'armGroupLabels': ['BED+ : Participants with obesity and binge eating disorder', 'BED-: Participants with obesity but without binge eating disorder']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Québec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Catherine Bégin, PhD', 'role': 'CONTACT'}], 'facility': "Centre d'expertise Poids, Image et Alimentation (CEPIA)", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Québec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'sylvain Iceta', 'role': 'CONTACT'}], 'facility': 'IUCPQ', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Sylvain Iceta, MD, PhD', 'role': 'CONTACT', 'email': 'equipe.iceta@criucpq.ulaval.ca', 'phone': '+1 (418) 656-8711', 'phoneExt': '4565'}, {'name': 'Pelletier Melissa', 'role': 'CONTACT', 'email': 'equipe.iceta@criucpq.ulaval.ca', 'phone': '+1 (418) 656-8711', 'phoneExt': '2136'}], 'overallOfficials': [{'name': 'Sylvain Iceta', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval', 'class': 'OTHER'}, {'name': "Centre d'expertise Poids, Image et Alimentation (CEPIA)", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sylvain Iceta', 'investigatorAffiliation': 'Laval University'}}}}