Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-31 @ 1:40 AM
Study NCT ID:
NCT05656859
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Eating Disorder Symptomatology Among Outpatients Referred to Health Promotion from Somatic Hospital Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The 5-level EQ-5D version (EQ-5D-5L)', 'timeFrame': '5 minutes', 'description': "Self-reported quality of life questionnaire. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).\n\nThe descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.\n\nThe EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement."}], 'primaryOutcomes': [{'measure': 'Eating Disorder Examination Questionnaire (EDE-Q)', 'timeFrame': '10 minutes', 'description': 'The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-reported questionnaire adapted from the semi-structured interview Eating Disorder Examination (EDE) and designed to assess the range and severity of features associated with a diagnosis of eating disorder using 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and a global score.\n\nThe EDE-Q generates two types of data: frequency data on key behavioural features of eating disorders in terms of number of episodes of the behaviour, and subscale scores reflecting the severity of characteristics of eating disorders.\n\nHigher scores on the global scale and subscales denote more problematic eating behaviours and attitudes.'}], 'secondaryOutcomes': [{'measure': 'Binge Eating Disorder Questionnaire (BED-Q)', 'timeFrame': '5 minutes', 'description': 'The Binge Eating Disorder Questionnaire (BED-Q) is a 9-item self-reported questionnaire. Items are rated on a 5-point Likert-type rating scale. Scores range between 0-32 and higher scores denote more problematic binge eating disorder. A diagnostic score that determine patient is diagnosed with Binge Eating Disorder or not can be calculated. 1 item rated "yes" or "no and other items are used to calculated a diagnostic score.'}, {'measure': 'Grazing Questionnaire (GQ)', 'timeFrame': '5 minutes', 'description': 'Grazing Questionnaire (GQ) is a 8-item self-reported questionnaire to measure behaviours and cognitions specific to grazing. Items are rated on a 5-point Likert-type rating scale where higher scores represent more grazing behaviours and cognitions. Scores are summes to form a total score (range: 0-32).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Disorders']}, 'descriptionModule': {'briefSummary': "The Department of Health Promotion at Aalborg University Hospital gets patients referred from all the hospital's departments. The Department of Health Promotion offers lifestyle courses to aid preventing disease relapses and further comorbidities to patients referred to other ambulatory treatments at the hospital. For most patients this also includes weight loss, but the primary goal is lifestyle change regarding eating and exercise habits to improve overall health state. Since it is known that eating disorders commonly occurs in individuals seeking help for weight loss, and that the prevalence is larger than in the background population, we also suspect that eating disorders would commonly occur among patients referred to the Department of Health Promotion. Therefore, we aim to investigate the prevalence of eating disorders among patients referred to lifestyle courses at the Department of Health Promotion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred to the Department of Health Promotion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to the Department of Health Promotion at Aalborg University Hospital, Denmark\n\nExclusion Criteria:\n\n* Under age 18\n* Not able to read and understand Danish\n* Not able to recieve mail in the danish digital postbox, e-Boks'}, 'identificationModule': {'nctId': 'NCT05656859', 'briefTitle': 'Prevalence of Eating Disorder Symptomatology Among Outpatients Referred to Health Promotion from Somatic Hospital Departments', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Prevalence of Eating Disorder Symptomatology Among Outpatients Referred to Health Promotion from Somatic Hospital Departments', 'orgStudyIdInfo': {'id': 'F2022-088'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Descriptive study', 'interventionNames': ['Behavioral: Single group']}], 'interventions': [{'name': 'Single group', 'type': 'BEHAVIORAL', 'description': 'Survey', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'North of Jutland', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tobias Christensen', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}