Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-28 @ 3:22 AM
Study NCT ID:
NCT04557566
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ED Recovery Course Online RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT- EBT Yoga-Based Course and Control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduced Eating Disorder Behaviors', 'timeFrame': 'at 4, 12, and 24 weeks', 'description': 'Reduced Eating Disorder Behaviors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Yoga-Based Recovery Course', 'Control']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether the Eat Breathe Thrive (EBT) Yoga for Eating Disorder Recovery online course is effective in supporting eating disorder recovery.', 'detailedDescription': 'We will conduct a block randomized controlled trial (RCT) comparing an intervention group and a waitlist control group. Participants in the intervention group will complete the Eat Breathe Thrive (EBT) Yoga for Eating Disorder Recovery online course. This course will be led by certified facilitators via Zoom and offered over the course of four weeks, comprising one two-hour session per week. The course will continue to recruit and enroll participants until sufficient power is reached for the study. At Pretest, Posttest 1, Posttest 2, and three-months Follow-Up, participants will complete a series of self-report measures (see point 12.3). Participants in the waitlist control group will only be engaged in the study assessment procedures. However, they will be given the opportunity to take part in the Yoga for Eating Disorder Recovery online course that was delivered to the intervention group, once Posttest 1 has been completed by both groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Identify as female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants included in the study sample will be people between the ages of 18 and 65, who self-identify as women, are not pregnant, are willing to sign the consent form, are English-speakers, have not taken any EBT course before, and self-identify as recovering from an eating disorder.\n\nExclusion Criteria:\n\n* The study will utilize the EBT participant application for screening (see attached). Further, those excluded will be people who do not self-identify as women, who are below 18 years old or above 65, pregnant, unable/refuse to sign the consent form, non-English speakers, have taken EBT before, and who do not self-identify as recovering from an eating disorder. Further, those who have suicidal ideations and engage in self-harm behaviors cannot be included.'}, 'identificationModule': {'nctId': 'NCT04557566', 'briefTitle': 'ED Recovery Course Online RCT', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'A Randomized Controlled Trial of the Eat Breathe Thrive Yoga for Eating Disorder Recovery Online Course', 'orgStudyIdInfo': {'id': 'STUDY00004821'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EBT yoga-based eating disorder course', 'description': 'Yoga for Eating Disorder Recovery online course. This course will be led by certified facilitators via Zoom and offered over the course of four weeks, comprising one two-hour session per week. The course will continue to recruit and enroll participants until sufficient power is reached for the study.', 'interventionNames': ['Behavioral: EBT yoga-based eating disorder course']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Wait list control'}], 'interventions': [{'name': 'EBT yoga-based eating disorder course', 'type': 'BEHAVIORAL', 'description': 'Yoga for Eating Disorder Recovery online course. This course will be led by certified facilitators via Zoom and offered over the course of four weeks, comprising one two-hour session per week. The course will continue to recruit and enroll participants until sufficient power is reached for the study.', 'armGroupLabels': ['EBT yoga-based eating disorder course']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14260', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo, SUNY', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eat Breathe Thrive', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Catherine Cook-Cottone', 'investigatorAffiliation': 'University at Buffalo'}}}}