Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-29 @ 7:21 PM
Study NCT ID:
NCT00961428
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2009-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivation to Exercise in People With Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'fasting blood draws to measure cortison and leptin levels'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physical activity', 'timeFrame': 'Physical activity before and after weight restoration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anorexia Nervosa', 'Eating Disorders', 'Exercise', 'Physical Activity'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine the importance and level of physical activity in people with Anorexia Nervosa.', 'detailedDescription': 'A laboratory paradigm that uses a progressive ratio computerized work task will be used to determine the reinforcing value of exercise in hospitalized patients with AN, both before and after weight gain. In addition, we will examine the relationship between the reinforcing value of exercise and free-living physical activity in this population. We will also examine the relationship between the reinforcing value of exercise and measures of depression, anxiety, and cortisol, which we have found in previous studies to be associated with other measures of physical activity and exercise motivation. In order to determine whether physical activity in women with AN differs from that of non-eating disordered women, we will extend studies of physical activity to free-living control participants. All adult patients and controls will undergo body composition assessment once to measure the association between physical activity and percent body fat. Finally, to determine the impact of exercise reinforcement and physical activity on outcome in women with AN, we will conduct follow-up assessments in all patient participants for one year after discharge from the inpatient treatment unit."'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be patients with anorexia nervosa on the inpatient unit at New York State Psychiatric Institute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of Anorexia Nervosa (except amenorrhea)\n* Female\n* Age 18-45\n* Medically Stable for exercise participation\n* At a minimum of 75% Ideal Body Weight\n\nExclusion Criteria:\n\n* Significant or current past medical illness including diabetes mellitis and heart disease\n* Current or lifetime history or schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR\n* Current suicidal ideation or recent suicidal behavior (within past 3 months)\n* Drug or alcohol abuse in last 6 months\n* Taking psychotropic medication\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00961428', 'briefTitle': 'Motivation to Exercise in People With Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Behavioral Assessment of the Reinforcing Effects of Exercise in Patients With Anorexia Nervosa', 'orgStudyIdInfo': {'id': '#5544'}, 'secondaryIdInfos': [{'id': 'K23MH071285-02', 'link': 'https://reporter.nih.gov/quickSearch/K23MH071285-02', 'type': 'NIH'}, {'id': 'NIMH K23 071285', 'type': 'OTHER_GRANT', 'domain': 'NIMH'}, {'id': 'DATR AK-TNAI1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'B. Timothy Walsh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NYSPI'}, {'name': 'Evelyn Attia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYSPI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}