Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01126918
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2010-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 432}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2010-05-18', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eating disorder symptoms, risk for future eating disorder and obesity onset', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'mediators to intervention effects', 'timeFrame': '2 years', 'description': 'We will test whether the dissonance program intervention effects are mediated by change in thin-ideal internalization'}, {'measure': 'moderators to program effects', 'timeFrame': '2 years', 'description': 'We will test whether certain factors moderate program effects (e.g., initial body dissatisfaction level).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Eating Disorders', 'Obesity', 'Body Dissatisfaction', 'Female'], 'conditions': ['Eating Disorders', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '39509183', 'type': 'DERIVED', 'citation': 'Stice E, Desjardins C, Shaw H, Siegel S, Gee K, Rohde P. Prevalence, incidence, impairment, course, and diagnostic progression and transition of eating disorders, overweight, and obesity in a large prospective study of high-risk young women. J Psychopathol Clin Sci. 2025 May;134(4):427-437. doi: 10.1037/abn0000965. Epub 2024 Nov 7.'}, {'pmid': '35653756', 'type': 'DERIVED', 'citation': 'Stice E, Desjardins CD, Rohde P. Young women who develop anorexia nervosa exhibit a persistently low premorbid body weight on average: A longitudinal investigation of an important etiologic clue. J Psychopathol Clin Sci. 2022 Jul;131(5):479-492. doi: 10.1037/abn0000762. Epub 2022 Jun 2.'}, {'pmid': '34180702', 'type': 'DERIVED', 'citation': 'Stice E, Desjardins CD, Rohde P, Shaw H. Sequencing of symptom emergence in anorexia nervosa, bulimia nervosa, binge eating disorder, and purging disorder and relations of prodromal symptoms to future onset of these disorders. J Abnorm Psychol. 2021 May;130(4):377-387. doi: 10.1037/abn0000666.'}, {'pmid': '32534455', 'type': 'DERIVED', 'citation': 'Stice E, Rohde P, Shaw H, Desjardins C. Weight suppression increases odds for future onset of anorexia nervosa, bulimia nervosa, and purging disorder, but not binge eating disorder. Am J Clin Nutr. 2020 Oct 1;112(4):941-947. doi: 10.1093/ajcn/nqaa146.'}]}, 'descriptionModule': {'briefSummary': 'This three-site effectiveness trial will test whether a brief dissonance-based eating disorder prevention program produces intervention effects when college counselors, psychologists, and nurses are responsible for participant recruitment, screening, and intervention delivery under ecologically valid conditions.', 'detailedDescription': 'Threshold and subthreshold eating disorders affect over 10% of young women and are associated with functional impairment, distress, psychiatric comorbidity, medical complications, mortality, and risk for obesity onset. Accordingly, a pressing public healthy priority is to develop effective prevention programs for eating pathology. The proposed project will be the first effectiveness trial to test whether an eating disorder prevention program with strong empirical support from efficacy trials produces effects under ecologically valid conditions among high-risk female college students, which is a vital step toward widespread dissemination of programs developed with NIH funding. The proposed cost-effectiveness analyses and examination of process factors that predict larger intervention effects will also represent novel contributions to the literature.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) is a registered student at a participating school, (2) self-reports body image concerns\n\nExclusion Criteria:\n\n* meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder'}, 'identificationModule': {'nctId': 'NCT01126918', 'briefTitle': 'Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Research Institute'}, 'officialTitle': 'Eating Disorders Prevention: An Effectiveness Trial for At-Risk College Students', 'orgStudyIdInfo': {'id': 'MH086582'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Brochure Condition', 'description': 'Participants in this condition receive an educational brochure about healthy body image via post-mail.', 'interventionNames': ['Behavioral: Body Project']}, {'type': 'EXPERIMENTAL', 'label': 'Group Condition', 'description': 'Participants in this condition attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction.', 'interventionNames': ['Behavioral: Body Project']}], 'interventions': [{'name': 'Body Project', 'type': 'BEHAVIORAL', 'description': 'Participants in this intervention attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction.', 'armGroupLabels': ['Brochure Condition', 'Group Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Christian University', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97403', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'University of Oregon', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19122', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78626', 'city': 'Georgetown', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwestern University', 'geoPoint': {'lat': 30.63269, 'lon': -97.67723}}], 'overallOfficials': [{'name': 'Eric Stice, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Research Institute'}, {'name': 'Meghan Butryn, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drexel University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Texas at Austin', 'class': 'OTHER'}, {'name': 'Drexel University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}