Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
Study NCT ID:
NCT01544400
Status:
TERMINATED
Last Update Posted:
2016-08-08
First Post:
2012-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Description and Evaluation of Eating Disorders in Elite Athletes (TCA SHN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D056912', 'term': 'Binge-Eating Disorder'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-05', 'studyFirstSubmitDate': '2012-02-17', 'studyFirstSubmitQcDate': '2012-02-28', 'lastUpdatePostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of eating disorder', 'timeFrame': '1 day', 'description': 'A subject presents an eating disorder if at least one of the tree clinical investigators (somatician, dietician, psychologist) mark it.\n\nEating disorders will be described by:\n\nDietetic consultation, Somatic examination, Psychological evaluation'}], 'secondaryOutcomes': [{'measure': 'Presence of eating disorder according to the psychologist, dietician and the somatician', 'timeFrame': '1 day', 'description': 'Presence of eating disorder according to the psychologist, dietician and the somatician'}, {'measure': 'Sociodemographic variables', 'timeFrame': '1 day', 'description': 'age, sex, sporting discipline exercised'}, {'measure': 'Doping conduits variables', 'timeFrame': '1 day', 'description': 'age of onset of consumption (PAP support products performance) legal and illegal, current frequency of consumption of PAP licit and illicit consumption as problematic or not the patient.'}, {'measure': 'Investment in practice sporting variables', 'timeFrame': '1 day', 'description': 'Desired level of sports, number of hours per week over the last 4 weeks, up / concern of the sport.'}, {'measure': 'Addictives and psychiatric comorbidity', 'timeFrame': '1 day', 'description': 'anxiety disorders, depression and sleep disorders Scale : GEEMS, EDI, EDS-R'}]}, 'conditionsModule': {'keywords': ['reverse anorexia,', 'anorexia athletics'], 'conditions': ['Eating Disorders', 'Anorexia Nervosa', 'Boulimia Nervosa', 'Binge Eating Disorders']}, 'descriptionModule': {'briefSummary': 'Athletes in particular elite athletes have obsessional food and body concerns, in bond with a worship of the performance more and more invading, which lead to clinical and subclinical eating disorders. These eating disorders differ according to the disciplines and are difficult to diagnose in athletes because there are insufficiently described.\n\nOur aim at estimating the frequency of eating disorders in athletes and describing eating disorders by means of somatic, dietetic and psychological evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Athletes registered on the high level sportsmen list or in access to high level sport', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to have at least 12 years\n* to be registered on the high level sportsmen list or to be in access to high level sport\n* to have obtained the non opposition of the athlete if he is major (if not the legal person in charge of the athlete have to give is non opposition).\n* to be affiliated to social security\n\nExclusion Criteria:\n\n* presenting obvious cognitive disturbance\n* not able to understand or/ and to read French language\n* pregnant women\n* subject under tutelage'}, 'identificationModule': {'nctId': 'NCT01544400', 'acronym': 'TCA SHN', 'briefTitle': 'Description and Evaluation of Eating Disorders in Elite Athletes (TCA SHN)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Description and Evaluation of Eating Disorders in Elite Athletes', 'orgStudyIdInfo': {'id': 'BRD/09/03-V'}}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'CHU Nantes', 'country': 'France', 'facility': 'Prétagut'}], 'overallOfficials': [{'name': 'Stephane Pretagut', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Serge Lise', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'Michel GUINOT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}