Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 11:58 AM
Study NCT ID:
NCT07311005
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-30
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NURSE - LED DIGITAL EDUCATION AND BIGOREXIA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-test-post-test education score difference', 'timeFrame': '8 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle Dysmorphia', 'Male Body İmage', 'Health Behavior', 'Bigorexia', 'Wellness', 'Nursing'], 'conditions': ['Bigorexia', 'Muscle Dysmorphia', 'Wellness', 'Nurse-Led Digital Education']}, 'descriptionModule': {'briefSummary': "In recent years, the desire to achieve a muscular body appearance has been increasingly observed among young men, and this situation may lead to unhealthy behaviors and psychological problems in some individuals. Bigorexia, also referred to as muscle dysmorphia, is considered a significant condition within body image disorders and is characterized by a persistent and unrealistic perception of not being sufficiently muscular.\n\nYoung men with tendencies toward bigorexia may experience negative body image, feel anxiety related to their physical appearance in social settings, and consequently suffer a decline in their quality of daily life. This phenomenon, which can lead to serious psychological, physical, and social problems, plays an important role in the lives of men. The present study aims to examine the effects of a 12-week digital-based education program provided to young men with bigorexia tendencies on body image, social physique anxiety, and levels of bigorexia.\n\nIn this research, the effects of a digital-based health education program developed for young men with bigorexia tendencies will be investigated. The study will be conducted using a randomized controlled experimental design, and the impact of the digital health education on participants' body image, social physique anxiety, and bigorexia levels will be evaluated. It is expected that the findings will provide evidence-based data to support the development of healthy lifestyle behaviors among young men, strengthen positive body image, and reduce the risk of bigorexia. Additionally, demonstrating the effectiveness of digital-based educational interventions is anticipated to introduce an innovative approach to public health nursing practice."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': '18- 30 years old man', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBeing between 18-30 years of age\n\nBeing male\n\nActively attending a gym/fitness center\n\nProviding voluntary informed consent to participate in the study\n\nScoring 39 or above on the Bigorexia Scale\n\nExclusion Criteria:\n\nBeing female\n\nHaving a communication impairment\n\nNot attending the education program for more than two weeks'}, 'identificationModule': {'nctId': 'NCT07311005', 'briefTitle': 'NURSE - LED DIGITAL EDUCATION AND BIGOREXIA', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Mediterranean University'}, 'officialTitle': 'THE EFFECT OF A NURSE-LED DIGITAL HEALTH EDUCATION PROGRAM ON BODY IMAGE SOCIAL PHYSIQUE ANXIETY AND MUSCLE DYSMORPHIA LEVELS IN YOUNG MEN WITH BIGOREXIA TENDENCIES: A RANDOMIZED CONTROLLED TRIAL', 'orgStudyIdInfo': {'id': 'EMU-BIGOREXIA-NURS-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'interventionNames': ['Other: Digital Education']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Digital Education', 'type': 'OTHER', 'description': 'In the study, the intervention group will receive a digital-based "Healthy Lifestyle Education for Bigorexia" consisting of 12 sessions. Each session will be conducted as an interactive module lasting approximately 60 minutes. The education will cover topics including balanced nutrition, regular physical activity, development of a healthy body image, and strategies for coping with social physique anxiety.\n\nThe educational materials will consist of video presentations, brief reading materials, and interactive exercises. Participants\' questions throughout the training will be addressed via online discussion platforms. At the end of the study, the scale-based assessments will be re-administered.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mersin', 'state': 'Mağusa', 'country': 'Turkey (Türkiye)', 'facility': 'EMU', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Mediterranean University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}