Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 7:22 AM
Study NCT ID:
NCT03529357
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2018-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Age in Worksite Health Promotion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5473}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-05-07', 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological Age', 'timeFrame': 'The Biological Age is calculated at baseline and at one year follow up', 'description': 'An algorithm calculates Biological Age, using physiological parameters and biomarkers measured during the test.'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'Measured at baseline and at one year follow up', 'description': 'BodyMassIndex is a major risk factor for developing lifestyle related diseases.'}, {'measure': 'Bodyweight', 'timeFrame': 'Measured at baseline and at one year follow up', 'description': 'The weight in kilograms of each individual'}, {'measure': 'FM', 'timeFrame': 'Measured at baseline and at one year follow up', 'description': 'Fat Mass is important to look at isolated in reference to whole bodyweight'}, {'measure': 'FFM', 'timeFrame': 'Measured at baseline and at one year follow up', 'description': 'Fat Free Mass is important to look at isolated in reference to Whole bodyweight'}, {'measure': 'BP', 'timeFrame': 'Measured at baseline and at one year follow up', 'description': 'Bloodpressure as a result from systolic and diastolic bloodpressure'}, {'measure': 'VO2max', 'timeFrame': 'Measured at baseline and at one year follow up', 'description': 'Maximal Oxygen consumption'}, {'measure': 'BG', 'timeFrame': 'Measured at baseline and at one year follow up', 'description': 'Blood Glucose'}, {'measure': 'HDL', 'timeFrame': 'Measured at baseline and at one year follow up', 'description': 'High Density Lipoprotein'}, {'measure': 'LDL', 'timeFrame': 'Measured at baseline and at one year follow up', 'description': 'Low Density Lipoprotein'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biological Age', 'Motivation'], 'conditions': ['Health Behavior', 'Biomedical Technology']}, 'descriptionModule': {'briefSummary': 'This cohort study investigates how implementation of Biological Age technology in worksite health promotion, affects health behavior in the general Danish working population.', 'detailedDescription': "This cohort study is designed on the basis of Body Age tests, executed by a private Danish health care company in the period from 2010 to 2013.\n\nThe dataset comprises pre- and post Body Age tests from \\>4000 individuals. They used a standardised protocol and educated staff ( physiotherapists or with a degree in sports science) to carry out the tests. Body Age tests apply biometrics, fitness level and health status data of the employee. The test results are characterized by a Body Age score, which defines the employee's biological age (in years).\n\nThis design categorises as a register study why The Danish National Committee is not applied for."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The volunteers are employees in either private or governmental companies. A total of 18 different companies are included in this study, primarily related to banking, pension and pharmaceutical work areas. The Body Age test is voluntary and part of the companies health strategy and fringe benefits.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females interested in their personal health status\n* Participants who perform both baseline and follow up test.\n\nExclusion Criteria:\n\n* Use of beta blockers'}, 'identificationModule': {'nctId': 'NCT03529357', 'acronym': 'BA1', 'briefTitle': 'Biological Age in Worksite Health Promotion', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Implementation of Biological Age in Worksite Health Promotion - a Cohort Study on >4000 Danish Employees and Their Health Risk Reductions', 'orgStudyIdInfo': {'id': 'BiologicalAge1'}}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen, Department of Biomedical Sciences', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jørn W Helge, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BMI, Xlab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Metropolitan University College', 'class': 'OTHER'}, {'name': 'Technical University of Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D., Proffesor Jørn Wulff Helge', 'investigatorFullName': 'Jørn Wulff Helge', 'investigatorAffiliation': 'University of Copenhagen'}}}}