Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-04-17 @ 7:56 PM
Study NCT ID:
NCT00777634
Status:
COMPLETED
Last Update Posted:
2012-05-29
First Post:
2008-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Follow-Up Extension to the Family Study of Binge Eating Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eryan@mclean.harvard.edu', 'phone': '617-855-2984', 'title': 'Study Coordinator', 'organization': 'McLean Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'This was an observational study, and so no participants were at risk. No intervention was administered.', 'eventGroups': [{'id': 'EG000', 'title': 'Binge Eating Disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Diagnosis of Dyslipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Binge Eating Disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.'}, {'id': 'OG001', 'title': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Diagnosis of Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Binge Eating Disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.'}, {'id': 'OG001', 'title': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Diagnosis of Type 2 Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Binge Eating Disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.'}, {'id': 'OG001', 'title': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Diagnosis of Any Metabolic Syndrome Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Binge Eating Disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.'}, {'id': 'OG001', 'title': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of one component of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Diagnosis of Two or More Metabolic Syndrome Components', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Binge Eating Disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.'}, {'id': 'OG001', 'title': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of two or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Diagnosis of Three or More Metabolic Syndrome Components', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Binge Eating Disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.'}, {'id': 'OG001', 'title': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of three or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Binge Eating Disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.'}, {'id': 'FG001', 'title': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '133'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Binge Eating Disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.'}, {'id': 'BG001', 'title': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '47.4', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-23', 'studyFirstSubmitDate': '2008-10-20', 'resultsFirstSubmitDate': '2012-03-09', 'studyFirstSubmitQcDate': '2008-10-20', 'lastUpdatePostDateStruct': {'date': '2012-05-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-23', 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Diagnosis of Dyslipidemia', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.'}, {'measure': 'Incidence of Diagnosis of Hypertension', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.'}, {'measure': 'Incidence of Diagnosis of Type 2 Diabetes', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.'}, {'measure': 'Incidence of Diagnosis of Any Metabolic Syndrome Component', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of one component of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.'}, {'measure': 'Incidence of Diagnosis of Two or More Metabolic Syndrome Components', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of two or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.'}, {'measure': 'Incidence of Diagnosis of Three or More Metabolic Syndrome Components', 'timeFrame': 'Baseline to 5 years', 'description': 'The number of participants to acquire a new diagnosis of three or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Binge Eating Disorder', 'Eating Disorder'], 'conditions': ['Binge Eating Disorder']}, 'referencesModule': {'references': [{'pmid': '20427731', 'type': 'DERIVED', 'citation': 'Hudson JI, Lalonde JK, Coit CE, Tsuang MT, McElroy SL, Crow SJ, Bulik CM, Hudson MS, Yanovski JA, Rosenthal NR, Pope HG Jr. Longitudinal study of the diagnosis of components of the metabolic syndrome in individuals with binge-eating disorder. Am J Clin Nutr. 2010 Jun;91(6):1568-73. doi: 10.3945/ajcn.2010.29203. Epub 2010 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'This study involves a 2.5 and 5 year follow-up interview for individuals who participated in the initial family study of binge eating disorder. The study includes individuals with and without eating disorder as well as their first degree relatives. As part of the study, participants will be interviewed about their current psychiatric and medical symptoms, their blood pressure will be measured, and laboratory specimens will be obtained.', 'detailedDescription': 'Previously we completed a family interview study of 150 individuals with binge eating disorder, 150 matched controls, and approximately 888 of their first degree relatives. In follow-up to this, we are interviewing these individuals again at 2.5 and 5 years after their initial interview. During the course of the interview, individuals are asked about their psychiatric and medical history and blood pressure and laboratory specimens are obtained to measure, among other things, fasting lipids and glucose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes individuals with binge eating disorder, individuals without binge eating disorder, and their relatives.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with or without binge eating disorder and their family members who participated in the initial family study of binge eating disorder and agree to be followed up at 2.5 and 5 years.\n\nExclusion Criteria:\n\n* Unwilling or unable to participate in the follow-up study.'}, 'identificationModule': {'nctId': 'NCT00777634', 'briefTitle': 'Follow-Up Extension to the Family Study of Binge Eating Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Mclean Hospital'}, 'officialTitle': 'Follow-Up Extension to the Family Study of Binge Eating Disorder', 'orgStudyIdInfo': {'id': '2005-P-000779'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Binge eating disorder (BED)', 'description': 'Individuals who meet criteria for binge eating disorder.', 'interventionNames': ['Other: No intervention.']}, {'label': 'Without BED', 'description': 'Individuals who do not meet criteria for binge eating disorder.', 'interventionNames': ['Other: No intervention.']}], 'interventions': [{'name': 'No intervention.', 'type': 'OTHER', 'description': 'There is no intervention used in this study. Cohort members are interviewed and blood pressure, weight, and laboratory specimens are obtained.', 'armGroupLabels': ['Binge eating disorder (BED)', 'Without BED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'McLean Hospital', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}], 'overallOfficials': [{'name': 'James I Hudson, M.D., Sc.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}, {'name': 'Harrison G Pope, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mclean Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ortho-McNeil Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry, Harvard Medical School', 'investigatorFullName': 'James I. Hudson, MD', 'investigatorAffiliation': 'Mclean Hospital'}}}}