Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 1:38 AM
Study NCT ID:
NCT05993728
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2023-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Body Project Groups Led by Peers Versus Clinicians
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The assessor completing the diagnostic interview will be blinded to the condition the participant is in (at all assessments)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 441}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-08-08', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change over time in eating disorder symptoms', 'timeFrame': 'Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years', 'description': 'Assessed with the 28-item self-report Eating Disorder Examination Questionnaire (EDE-Q). Responses range from 0-6, whith higher scores indicating more severe eating disorder psychopathology'}, {'measure': 'Rate of eating disorder onset', 'timeFrame': 'Baseline/pretest, 1-year, and at 2-years', 'description': 'Assessed with the eating disorder diagnostic interview Eating Disorder Assessment-5 (EDA-5). This is a semi-structured clinician-led diagnostic interview, based on the diagnostic criteria in the diagnostic manual DSM-5, and is efficient to determine eating disorder diagnostic status. This outcome will be used to determine proportion of participants with an eating disorder diagnosis.'}, {'measure': 'Change over time in Body dissatisfaction', 'timeFrame': 'Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years', 'description': 'Assessed with the 10-item Body Dissatisfaction Scale (BDI; Berscheid et al., 2973) which assesses dissatisfaction with various body parts. Each item is scored on a scale of 1 = extremely dissatisfied to 5 = extremely satisfied. Lower scores indicate greater body dissatisfaction'}, {'measure': 'Change over time in thin-ideal internalization', 'timeFrame': 'Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years', 'description': 'Assessed with the 8-item Ideal-Body Stereotype Scale-Revised (Stice et al., 2017) which measures pursuit of the thin ideal. Each item is scored on a scale of 1 = strongly disagree to 5 = strongly agree. Higher scores indicate greater belief in the thin-deal.'}, {'measure': 'Negative affect', 'timeFrame': 'Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years', 'description': '20 negative items from the Positive and Negative Affect Schedule - Revised (PANAS-X) (Watson \\& Clark, 1992) to measure negative affect. Higher scores indicate higher levels of negative affect. Responses range from 1-5'}], 'secondaryOutcomes': [{'measure': 'Change over time in appearance ideals and perceived pressures', 'timeFrame': 'Baseline/pretest, posttest right after intervention (an average of 8 weeks), and at follow-up after 6-months, 1-year, and 2-years', 'description': 'Assessed with the Attitudes Towards Appearance Questionnaire (SATAQ-4R) (Schaefer et al., 2017). A total of 31 items are included, and responses range from 1-5. Higher scores indicate higher levels of internalization/pressures'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prevention', 'Body acceptance'], 'conditions': ['Eating Disorders', 'Body Image']}, 'referencesModule': {'references': [{'pmid': '38001544', 'type': 'DERIVED', 'citation': 'Wisting L, Stice E, Ghaderi A, Dahlgren CL. Effectiveness of virtually delivered Body Project groups to prevent eating disorders in young women at risk: a protocol for a randomized controlled trial. J Eat Disord. 2023 Nov 24;11(1):209. doi: 10.1186/s40337-023-00932-7.'}]}, 'descriptionModule': {'briefSummary': 'Eating disorders (EDs) are a group of illnesses associated with significant psychological and physiological consequences. Overall, only 20% of individuals with EDs receive treatment and treatment is effective for only about 25-35% for those who receive care. The development and implementation of effective prevention approaches for those at risk is therefore pivotal. The Body Project is the most effective ED prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. Further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. With this application, the investigators therefore propose to examine the effectiveness of the Body Project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered Body Project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'genderBased': True, 'genderDescription': 'Female-identifying', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 16-25\n* Female identifying\n* Self-reported body image concerns\n\nExclusion Criteria:\n\n* Ongoing eating disorder diagnosis requiring treatment or hospitalization'}, 'identificationModule': {'nctId': 'NCT05993728', 'acronym': 'v-BP', 'briefTitle': 'Virtual Body Project Groups Led by Peers Versus Clinicians', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Effectiveness of the Body Project to Prevent Eating Disorders in Young Females at Risk: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '609734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinician-led Body Project', 'description': 'Participants randomized to this condition will take part in virtual Body Project groups led by clinicians.', 'interventionNames': ['Behavioral: Body Project']}, {'type': 'EXPERIMENTAL', 'label': 'Peer-led Body Project', 'description': 'Participants randomized to this condition will take part in virtual Body Project groups led by peers.', 'interventionNames': ['Behavioral: Body Project']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational control', 'description': 'Participants randomized to the educational control group will receive educational videos on body image and eating disorders', 'interventionNames': ['Behavioral: Psychoeducational control']}], 'interventions': [{'name': 'Body Project', 'type': 'BEHAVIORAL', 'description': 'The Body Project prevention program is a body acceptance program to promote a healthy body image and prevent eating disorder onset.', 'armGroupLabels': ['Clinician-led Body Project', 'Peer-led Body Project']}, {'name': 'Psychoeducational control', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to the educational control condition will receive videos addressing body image and eating disorders', 'armGroupLabels': ['Educational control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Line Wisting, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Oslo New University College, Norway', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Line Wisting', 'investigatorAffiliation': 'Oslo University Hospital'}}}}