Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-04-15 @ 4:47 PM
Study NCT ID:
NCT01735994
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2012-11-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of the Female Athlete Body Project (FAB)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D053716', 'term': 'Female Athlete Triad Syndrome'}], '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': 'D000080822', 'term': 'Relative Energy Deficiency in Sport'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tiffany.stewart@pbrc.edu', 'phone': '2257632554', 'title': 'Dr. Tiffany Stewart, Director, Behavior Technology Laboratory', 'organization': 'Pennington Biomedical Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The cluster randomized control trial design by team reduced statistical power. We could not control for team-based variability. Selective attrition may have occurred by the intervention of school athletic medical staff.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over a period of 18 months.', 'description': 'Because this study involved the evaluation of an athlete prevention program via assessment measures, with oversight by the school athletic department, minimal risk was anticipated in this remote study. Adverse events related to the study (questionnaires) were monitored. Participants were also monitored by the school athletic department based on their previously established protocols.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Weight Intervention', 'description': 'Eating Disorder Prevention Program\n\nHealthy Weight: Eating Disorder Prevention Program for Athletes', 'otherNumAtRisk': 263, 'deathsNumAtRisk': 263, 'otherNumAffected': 0, 'seriousNumAtRisk': 263, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Brochure Wait List', 'description': 'Brochure wait list control group\n\nBrochure: Brochure on the Female athlete triad', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 0, 'seriousNumAtRisk': 218, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Eating Disorder Examination Questionnaire (EDE-Q)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Weight Intervention', 'description': 'Eating Disorder Prevention Program\n\nHealthy Weight: Eating Disorder Prevention Program for Athletes'}, {'id': 'OG001', 'title': 'Brochure Wait List', 'description': 'Brochure wait list control group\n\nBrochure: Brochure on the Female athlete triad'}], 'classes': [{'title': 'Global', 'categories': [{'measurements': [{'value': '.98', 'spread': '.17', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '.16', 'groupId': 'OG001'}]}]}, {'title': 'Restraint', 'categories': [{'measurements': [{'value': '.54', 'spread': '.11', 'groupId': 'OG000'}, {'value': '.84', 'spread': '.18', 'groupId': 'OG001'}]}]}, {'title': 'Shape Concern', 'categories': [{'measurements': [{'value': '1.13', 'spread': '.21', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '.28', 'groupId': 'OG001'}]}]}, {'title': 'Weight Concern', 'categories': [{'measurements': [{'value': '1.03', 'spread': '.26', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '.24', 'groupId': 'OG001'}]}]}, {'title': 'Eating Concern', 'categories': [{'measurements': [{'value': '.49', 'spread': '.16', 'groupId': 'OG000'}, {'value': '.55', 'spread': '.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'The Eating Disorder Examination Questionnaire (EDE-Q) assesses eating disorder behaviors through a self-report questionnaire. There are four subscales of the EDE-Q--Restraint, Eating Concern, Shape Concern, and Weight Concern--with scores for each ranging from 0-6. Overall scores also range from 0-6. Higher scores reflect greater severity of eating disorder psychopathology. Subscales are averaged to compute a total score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Weight Intervention', 'description': 'Eating Disorder Prevention Program\n\nHealthy Weight: Eating Disorder Prevention Program for Athletes'}, {'id': 'OG001', 'title': 'Brochure Wait List', 'description': 'Brochure wait list control group\n\nBrochure: Brochure on the Female athlete triad'}], 'classes': [{'title': 'Internalization of the Sport-Specific Thin-Ideal', 'categories': [{'measurements': [{'value': '2.46', 'spread': '.18', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '.31', 'groupId': 'OG001'}]}]}, {'title': 'Teammate Relationship Health (TRH)', 'categories': [{'measurements': [{'value': '30.28', 'spread': '.65', 'groupId': 'OG000'}, {'value': '29.87', 'spread': '.85', 'groupId': 'OG001'}]}]}, {'title': 'Ideal-Body Stereotype Scale - Revised (IBSSR)', 'categories': [{'measurements': [{'value': '3.20', 'spread': '.06', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '.05', 'groupId': 'OG001'}]}]}, {'title': 'Positive and Negative Affect Scale - Revised', 'categories': [{'measurements': [{'value': '1.50', 'spread': '.04', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '.06', 'groupId': 'OG001'}]}]}, {'title': 'Intervention Suitability Expectations (ISE)', 'categories': [{'measurements': [{'value': '29.92', 'spread': '7.80', 'groupId': 'OG000'}, {'value': '26.50', 'spread': '8.52', 'groupId': 'OG001'}]}]}, {'title': 'Knowledge of the Female Athlete Triad', 'categories': [{'measurements': [{'value': '8.54', 'spread': '.37', 'groupId': 'OG000'}, {'value': '8.58', 'spread': '.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Internalization of the Sport-Specific Thin-Ideal (ISTI) measures thin-ideal internalization specific to athletes (average of items from 1-5; higher scores mean worse outcome).\n\nTeammate Relationship Health (TRH) measures relational health with teammates (scores from 8-40; higher scores mean better outcome).\n\nIdeal-Body Stereotype Scale - Revised (IBSS-R) assesses internalization of the traditional thin-ideal (scores from 1-10, higher scores mean worse outcome).\n\nPositive and Negative Affect Scale - Revised (PANAS-X) assesses negative affect (average of items from 1-5; higher scores mean worse outcome).\n\nIntervention Suitability Expectations (ISE) assesses perceived suitability and expectations of the intervention (average of total scores from 4-46; higher scores mean better outcome).\n\nKnowledge of the Female Athlete Triad (KFAT) measures participant understanding of the Female Athlete Triad (each correct answer = 1, scores from 0-10; higher scores mean better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Weight Intervention', 'description': 'Eating Disorder Prevention Program\n\nHealthy Weight: Eating Disorder Prevention Program for Athletes'}, {'id': 'OG001', 'title': 'Brochure Wait List', 'description': 'Brochure wait list control group\n\nBrochure: Brochure on the Female athlete triad'}], 'classes': [{'title': 'Objective Binge Episode Frequency', 'categories': [{'measurements': [{'value': '.35', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '.63', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': 'Subjective Binge Episode Frequency', 'categories': [{'measurements': [{'value': '.49', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '.57', 'spread': '3.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Frequency of subjective and objective binge episodes is reported.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Outcomes - BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Weight Intervention', 'description': 'Eating Disorder Prevention Program\n\nHealthy Weight: Eating Disorder Prevention Program for Athletes'}, {'id': 'OG001', 'title': 'Brochure Wait List', 'description': 'Brochure wait list control group\n\nBrochure: Brochure on the Female athlete triad'}], 'classes': [{'categories': [{'measurements': [{'value': '25.09', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '24.22', 'spread': '.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'Body Mass Index (BMI) (self-reported) is a measure of kg/m\\^2.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Weight Intervention', 'description': 'Eating Disorder Prevention Program\n\nHealthy Weight: Eating Disorder Prevention Program for Athletes'}, {'id': 'FG001', 'title': 'Brochure Wait List', 'description': 'Brochure wait list control group\n\nBrochure: Brochure on the Female athlete triad'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '263'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '218'}]}, {'type': 'Post Intervention (3 Weeks)', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '239'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '198'}]}, {'type': 'Follow-Up #1 (6 Months)', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '213'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '163'}]}, {'type': 'Follow-Up #2 (12 Months)', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '212'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '200'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '63'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Injury', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Kicked off team', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '62'}]}]}], 'typeUnitsAnalyzed': 'teams', 'recruitmentDetails': 'Study enrollment began at the schools in August 2012 and completed in October 2014.', 'preAssignmentDetails': 'Only one athlete decided to participate in the prevention program without participating in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Weight Intervention', 'description': 'Eating Disorder Prevention Program\n\nHealthy Weight: Eating Disorder Prevention Program for Athletes'}, {'id': 'BG001', 'title': 'Brochure Wait List', 'description': 'Brochure wait list control group\n\nBrochure: Brochure on the Female athlete triad'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.29', 'spread': '1.25', 'groupId': 'BG000'}, {'value': '19.42', 'spread': '1.18', 'groupId': 'BG001'}, {'value': '19.35', 'spread': '1.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (inches)', 'classes': [{'categories': [{'measurements': [{'value': '65.95', 'spread': '3.39', 'groupId': 'BG000'}, {'value': '66.18', 'spread': '4.00', 'groupId': 'BG001'}, {'value': '66.05', 'spread': '3.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (pounds)', 'classes': [{'categories': [{'measurements': [{'value': '140.80', 'spread': '22.47', 'groupId': 'BG000'}, {'value': '138.80', 'spread': '23.72', 'groupId': 'BG001'}, {'value': '139.90', 'spread': '23.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Self-reported', 'unitOfMeasure': 'pounds', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.74', 'spread': '3.01', 'groupId': 'BG000'}, {'value': '22.23', 'spread': '2.65', 'groupId': 'BG001'}, {'value': '22.50', 'spread': '2.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-07-10', 'size': 2741144, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-17T11:09', 'hasProtocol': True}, {'date': '2013-07-10', 'size': 290742, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-04-17T11:17', 'hasProtocol': False}, {'date': '2019-09-04', 'size': 221107, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-09-04T15:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 481}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-12', 'studyFirstSubmitDate': '2012-11-14', 'resultsFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-12', 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eating Disorder Examination Questionnaire (EDE-Q)', 'timeFrame': '18 months', 'description': 'The Eating Disorder Examination Questionnaire (EDE-Q) assesses eating disorder behaviors through a self-report questionnaire. There are four subscales of the EDE-Q--Restraint, Eating Concern, Shape Concern, and Weight Concern--with scores for each ranging from 0-6. Overall scores also range from 0-6. Higher scores reflect greater severity of eating disorder psychopathology. Subscales are averaged to compute a total score.'}, {'measure': 'Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q)', 'timeFrame': '18 months', 'description': 'Frequency of subjective and objective binge episodes is reported.'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcomes', 'timeFrame': '18 months', 'description': 'Internalization of the Sport-Specific Thin-Ideal (ISTI) measures thin-ideal internalization specific to athletes (average of items from 1-5; higher scores mean worse outcome).\n\nTeammate Relationship Health (TRH) measures relational health with teammates (scores from 8-40; higher scores mean better outcome).\n\nIdeal-Body Stereotype Scale - Revised (IBSS-R) assesses internalization of the traditional thin-ideal (scores from 1-10, higher scores mean worse outcome).\n\nPositive and Negative Affect Scale - Revised (PANAS-X) assesses negative affect (average of items from 1-5; higher scores mean worse outcome).\n\nIntervention Suitability Expectations (ISE) assesses perceived suitability and expectations of the intervention (average of total scores from 4-46; higher scores mean better outcome).\n\nKnowledge of the Female Athlete Triad (KFAT) measures participant understanding of the Female Athlete Triad (each correct answer = 1, scores from 0-10; higher scores mean better outcome).'}, {'measure': 'Secondary Outcomes - BMI', 'timeFrame': '18 months', 'description': 'Body Mass Index (BMI) (self-reported) is a measure of kg/m\\^2.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Eating disorders', 'body image', 'female athletes', 'female athlete triad', 'eating disorder prevention', 'cluster randomization', 'risk factors', 'prevention'], 'conditions': ['Eating Disorders', 'Female Athlete Triad']}, 'referencesModule': {'references': [{'pmid': '28611008', 'type': 'BACKGROUND', 'citation': 'Stewart TM, Pollard T, Hildebrandt T, Beyl R, Wesley N, Kilpela LS, Becker CB. The Female Athlete Body (FAB) study: Rationale, design, and baseline characteristics. Contemp Clin Trials. 2017 Sep;60:63-71. doi: 10.1016/j.cct.2017.06.005. Epub 2017 Jun 10.'}, {'pmid': '31350934', 'type': 'BACKGROUND', 'citation': 'Stewart TM, Pollard T, Hildebrandt T, Wesley NY, Kilpela LS, Becker CB. The Female Athlete Body project study: 18-month outcomes in eating disorder symptoms and risk factors. Int J Eat Disord. 2019 Nov;52(11):1291-1300. doi: 10.1002/eat.23145. Epub 2019 Jul 27.'}, {'pmid': '33952348', 'type': 'DERIVED', 'citation': 'Stewart T, Kilpela L, Wesley N, Baule K, Becker C. Psychometric properties of the contextual body image questionnaire for athletes: a replication and extension study in female collegiate athletes. J Eat Disord. 2021 May 5;9(1):59. doi: 10.1186/s40337-021-00414-8.'}]}, 'descriptionModule': {'briefSummary': 'Given the cost of treating eating disorders and the substantial morbidity and mortality associated with these disorders, prevention of eating disorders has considerable public health significance. Female athletes represent an important population for prevention due to their risk for the Female Athlete Triad, which includes inadequate energy intake, irregular or cessation of menses, and osteoporosis. The proposed randomized controlled trial will provide important information regarding the efficacy, acceptability, and feasibility of implementing a brief eating disorder prevention and healthy living program within an existing social system of female athletes.', 'detailedDescription': 'Research supports the use of a Healthy Weight (HW) program targeting small lifestyle modifications in the prevention of ED onset and in reducing ED risk factors. Studies show that HW can be tailored for specific social systems (e.g., sororities) which can facilitate dissemination and that undergraduate peer-leaders can implement these programs. Interventions that can be administered affordably by endogenous providers are more likely to be disseminated, as indicated by the large scale dissemination of a peer-led ED prevention program by a national sorority. Another target social system for dissemination of ED prevention is collegiate athletics. Research suggests that disordered eating among female athletes is prevalent, and that this group is at greater, or at least equal, risk for developing EDs as non-athlete females. Disordered eating is especially dangerous in female athletes because it increases risk for the Female Athlete Triad (i.e., low energy availability/disordered eating, menstrual disorders, and decreased bone mineral density/osteoporosis) and subsequent injury. Moreover, the triad puts athletes at risk for serious long-term health consequences, such as osteoporosis, reproductive disorders, and cardiovascular disease. Despite this, efforts aimed at prevention of EDs among this group remain surprisingly limited. A pilot study with female athletes suggests that a modified version of HW can be successfully implemented by peer-leaders within the constraints of a competitive athletics program with positive effects at 12 month follow-up. The proposed study is to evaluate a randomized controlled trial of the HW intervention among female athletes. 500 female collegiate athletes from three sites will be randomized to either the HW prevention program or a brochure waitlist control condition using group (cluster) randomization based on teams. Participants will complete surveys and telephone interviews at pretest, posttest, and at 6 and 12 month follow-ups. The investigators will examine; (1) the efficacy of HW in reducing empirically supported ED risk factors relative to a waitlist brochure control condition at one year, (2) whether HW impacts secondary outcomes, including knowledge and identification of the female athlete triad, treatment seeking for the triad, affect, and health care utilization, and (3) whether positive effects for HW replicate the effects from the pilot study at one year and 18 months for the HW condition only. Based on previous promising findings, the department of athletics involved in the study have chosen to implement HW to all athletics teams on a mandatory basis on a staggered schedule. Given that it is unethical to require human subjects to participate in research, the proposed study (i.e., the study) must be separated from the program (i.e., the athlete prevention program) it aims to assess. Thus, the overall study will evaluate (via assessment measures) the program that the departments of athletics deliver at three sites, i.e. LSU, TU/IW, and AU.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Member of a University-sponsored athletic team,\n* Are willing and able to provide informed consent, attend all study visits, and comply with the study protocol\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01735994', 'acronym': 'FAB', 'briefTitle': 'Efficacy of the Female Athlete Body Project (FAB)', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Healthy Weight Intervention in Female Athletes: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PBRC 11032'}, 'secondaryIdInfos': [{'id': 'R01MH094448', 'link': 'https://reporter.nih.gov/quickSearch/R01MH094448', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Weight Intervention', 'description': 'Eating Disorder Prevention Program', 'interventionNames': ['Behavioral: Healthy Weight']}, {'type': 'OTHER', 'label': 'Brochure wait list', 'description': 'Brochure wait list control group', 'interventionNames': ['Other: Brochure']}], 'interventions': [{'name': 'Healthy Weight', 'type': 'BEHAVIORAL', 'description': 'Eating Disorder Prevention Program for Athletes', 'armGroupLabels': ['Healthy Weight Intervention']}, {'name': 'Brochure', 'type': 'OTHER', 'description': 'Brochure on the Female athlete triad', 'armGroupLabels': ['Brochure wait list']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Tiffany M Stewart, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Behavior Technology Laboratory', 'investigatorFullName': 'Tiffany Stewart', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}