Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT01738061
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2012-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multidimensional Lifestyle Intervention to Reduce the Risk of Metabolic Disorders in Older Workers in Taiwan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2012-11-28', 'studyFirstSubmitQcDate': '2012-11-29', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in anthropometric and srum biochemical indicators.', 'timeFrame': 'At baseline (week 0) and endpoint (week 24) of the intervention', 'description': 'Body weight (BW), body height, waist circumference, Body mass index (BMI), arterial blood pressure (BP), serum total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and glycosylated hemoglobin (HbA1c) concentrations'}], 'secondaryOutcomes': [{'measure': 'Lifestyle factors', 'timeFrame': 'At baseline (week 0) and endpoint (week 24) of the intervention', 'description': 'Physical activity, food consumption frequency and self-reported sleep and sedentary hours.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Older workers', 'Multidimensional intervention', 'Worksite health promotion', 'Taiwan'], 'conditions': ['Metabolic Disorder']}, 'descriptionModule': {'briefSummary': 'The study was aimed to evaluate the effectiveness of a multidimensional worksite intervention program to reduce the severity of metabolic disorders in older workers in Taiwan.', 'detailedDescription': 'The investigators conducted a quasi-experiment in older workers from three worksites in southern Taiwan.\n\n* Qualified subjects were assigned to the intervention or the reference group according to their availability to take part in study activities.\n* A researcher reviewed the health record and discussed with the subject about his/her health status.\n* Subjects in the intervention group received lifestyle interventions. The activities included motivational presentations to increase awareness of own health problems and the role of lifestyle in the etiology of non-communicable chronic diseases.\n* Subjects were organized into small groups to have biweekly meetings to share experiences, stimulate mutual encouragement and to overcome obstacles.\n* Anthropometric and biochemical indicators were measured at baseline and endpoint (week 24).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* full-time worker\n* aged 50 years or older\n* willing to complete a screening questionnaire\n* sign a study consent\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01738061', 'briefTitle': 'A Multidimensional Lifestyle Intervention to Reduce the Risk of Metabolic Disorders in Older Workers in Taiwan', 'organization': {'class': 'OTHER', 'fullName': 'Asia University'}, 'officialTitle': 'A Multidimensional Lifestyle Intervention to Reduce the Risk of Metabolic Disorders in Older Workers in Taiwan', 'orgStudyIdInfo': {'id': 'MM-WHP-99'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'reference group', 'description': 'They continued their daily routine.'}, {'type': 'EXPERIMENTAL', 'label': 'Multidimensional lifestyle intervention', 'description': 'The multidimensional lifestyle intervention program received motivational activities to improve awareness of the impact of lifestyle on chronic diseases and the importance of self-health management.', 'interventionNames': ['Behavioral: Multidimensional lifestyle intervention']}], 'interventions': [{'name': 'Multidimensional lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'Lecture series to increase awareness of the relationship of lifestyle to chronic diseases Individualized review and discussion to understand own health problems Biweekly group meetings to stimulate motivation and exchange ideas', 'armGroupLabels': ['Multidimensional lifestyle intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alan C Tsai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Healthcare Administration, Asia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Health, Executive Yuan, R.O.C. (Taiwan)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Alan C. Tsai, Ph. D.', 'investigatorAffiliation': 'Asia University'}}}}