Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT04138732
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2017-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health Behaviors of Medical Personnel in Hospital Maternity Ward
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-16', 'studyFirstSubmitDate': '2017-08-27', 'studyFirstSubmitQcDate': '2019-10-23', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac risk factors', 'timeFrame': 'at the end of the 1 year treatment', 'description': 'Initially assessed by in depth interviews with key personnel and focus groups and then assessed by self report through questionnaires.'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'at the end of 1 year of treatment', 'description': 'pre and post assesment of BMI via self reporting'}, {'measure': 'Burnout', 'timeFrame': 'at the end of the 1 year treatment,', 'description': 'Initially assessed by in depth interviews with key personnel and focus groups and then assessed by self report through questionnaires.'}, {'measure': 'Nutrition behaviors', 'timeFrame': 'at the end of the 1 year treatment', 'description': 'Initially assessed by in depth interviews with key personnel and focus groups and then assessed by self report through questionnaires assessing mediterrean diet adherence and western diet behavior'}, {'measure': 'Physical activity minutes per week', 'timeFrame': 'at the end of the 1 year treatment', 'description': 'Initially assessed by in depth interviews with key personnel and focus groups and then assessed by self report through questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Community', 'Health', 'Hospital'], 'conditions': ['Health Behavior', 'Behavior']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the existing health behaviors and obstacles to healthy lifestyle among the medical staff in a maternity ward in order to develop a specifically-tailored intervention to help improve the health behaviors of hospital shift workers.The findings will be used to establish a community-based participatory health-promoting program in the ward, engaging the staff in its development and implementation.', 'detailedDescription': 'The purpose of this study is to characterize the existing health behaviors and obstacles to healthy lifestyle among the medical staff in a maternity ward in order to develop a specifically-tailored intervention to help improve the health behaviors of hospital shift workers. Shift-work has been associated with unhealthy lifestyles and increased risk of digestive disorders, heart conditions, various kinds of cancer, reproductive dysfunction, and mental conditions. Thus, the findings will be used to establish a community-based participatory health-promoting program in the ward, engaging the staff in its development and implementation. Community Based Participatory (CBP) approach will be used to build an evaluation and intervention. Baseline/needs assessment will be performed by mixed methods approach, combining in depth interviews with key personnel, focus groups and questionnaires that ask about demographics, physical activity and nutrition behaviors, stress, burnout, BMI, and cardiac risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Doctors, nurses, secretaries, and assistants\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04138732', 'briefTitle': 'Health Behaviors of Medical Personnel in Hospital Maternity Ward', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Health Behaviors of Medical Personnel in Hospital Maternity Ward- Community Based Participatory Pilot', 'orgStudyIdInfo': {'id': '723HBM- HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention treatment group', 'description': 'This arm will receive the intervention treatment aimed to help improve their health behaviors. Interventions will include nutrition workshops and personal consultation for employees at risk, environmental intervention that includes brief exercise session prior to weekly meetings, placement of sports equipment in the department, and pedometer program, and stress reduction workshops. Healthy options will be demarcated in the hospital cafeteria.', 'interventionNames': ['Behavioral: Improve health behaviors of medical personel']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'This arm will be the control group and not receive the intervention treatment aimed to help improve their health behaviors.Once completing their time as the control group, they will continue into another phase of the trial and receive the intervention treatment.', 'interventionNames': ['Behavioral: Improve health behaviors of medical personel']}], 'interventions': [{'name': 'Improve health behaviors of medical personel', 'type': 'BEHAVIORAL', 'description': 'This arm will receive the intervention treatment aimed to help improve their health behaviors, as determined by employee-based steering committee. Interventions will target nutrition, physical activity and stress reduction', 'armGroupLabels': ['Control group', 'Intervention treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Donna Zwas, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Linda Joy Pollin Cardiovascular Wellness Center for Women', 'investigatorFullName': 'Donna R Zwas', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}