Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-01 @ 7:48 PM
Study NCT ID:
NCT05489835
Status:
UNKNOWN
Last Update Posted:
2023-01-11
First Post:
2022-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Work-Health-Life-Balance - Mental Resilience, Stability & Healthy Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress', 'timeFrame': '3 months', 'description': 'Stress-Erholungsfragebogen (RESTQ); minimum value: 0, maximum value: 294; High scores reflect high subjective stress.'}], 'secondaryOutcomes': [{'measure': 'Sleep', 'timeFrame': '3 months', 'description': 'Insomnis severity index: minimum value: 0, maximum value: 28; High scores reflect the presence of sleeping disorders'}, {'measure': 'Body mass index', 'timeFrame': '3 months', 'description': 'Body mass index (BMI); BMI= body weight / (body height)²'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Stress', 'Nutritional Quality', 'Burn-out Syndrome', 'Sleep', 'Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'New working environments (digitalization, flexibilization) can lead to increased levels of stress. A balanced work-life balance is therefore important in order to prevent negative effects of stress on mental health.\n\nThis study investigates,\n\n1. how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions.\n2. how standardized nutritional training affects individual body composition (measured using Bioelectrical Impedance Analyses, BIA), stress perception, burn-out symptoms and sleep.', 'detailedDescription': 'The ways of working must adapt to the challenges and opportunities of the digital world. Work 4.0 describes the process of change in the working environment in the digital age. Adapting to rapidly changing and sometimes uncertain living and working conditions in times of digitization, dislocated working (including "home office") and altered work processes demands a considerable effort of resources from numerous employees. Previously established work environments and behaviors are being evaluated and adapted to the new circumstances and requirements.\n\nSuch times of change often cause uncertainty and result in increased stress levels. Stress, in turn, leads to a variety of symptoms in many areas of life and work, which can limit the ability to work. As a result, successful adaptation to the challenges of the new work reality of Work 4.0 can fail.\n\nResearch Questions:\n\nThis study investigates,\n\n1. how stress, recovery, nutritional behavior, resilience and sleep behavior are related to the changed working conditions and central characteristics of work 4.0.\n2. how standardized nutritional training based on the Austrian Food Pyramid affects individual body composition (measured using Bioelectrical Impedance Analyses, BIA), stress perception, burn-out symptoms and sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'employees in austrian companies affected by digitalization', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* employees in austrian companies affected by digitalization\n* Informed consent\n\nExclusion Criteria:\n\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT05489835', 'briefTitle': 'Work-Health-Life-Balance - Mental Resilience, Stability & Healthy Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Work-Health-Life-Balance 4.0 - Mental Resilience, Stability & Healthy Nutrition in a New Work Reality', 'orgStudyIdInfo': {'id': 'EK 34-147 ex 21/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Employees', 'description': 'Employees in Austrian companies affected by digitalization', 'interventionNames': ['Behavioral: Nutritional counseling']}], 'interventions': [{'name': 'Nutritional counseling', 'type': 'BEHAVIORAL', 'description': 'Nutritional counseling', 'armGroupLabels': ['Employees']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Andreas Baranyi, Prof. MD', 'role': 'CONTACT', 'email': 'an.baranyi@medunigraz.at', 'phone': '+4331638586241'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Andreas Baranyi, M.D.', 'role': 'CONTACT', 'email': 'an.baranyi@medunigraz.at', 'phone': '0043-316-385-86241'}, {'name': 'Melanie Schweinzer', 'role': 'CONTACT', 'email': 'melanie.schweinzer@medunigraz.at'}], 'overallOfficials': [{'name': 'Andreas Baranyi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz, Auenbruggerplatz 31, 8036 Graz, Austria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Andreas Baranyi', 'investigatorAffiliation': 'Medical University of Graz'}}}}