Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 9:52 PM
Study NCT ID:
NCT01484834
Status:
COMPLETED
Last Update Posted:
2017-08-15
First Post:
2011-11-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Interventions to Promote Health in Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'grandeto@unesc.net', 'phone': '04834312500', 'title': 'Dr. Antonio Jose Grande', 'phoneExt': '2571', 'organization': 'UNESC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'data were collected after 3 months.', 'description': 'Number of Events Definition: Number of occurrences, in each arm/group, of the adverse event being reported\n\nNone adverse events were reported by any worker in this research', 'eventGroups': [{'id': 'EG000', 'title': 'Exercise in the Workplace and Educational Intervention', 'description': 'Company A received exercise in the workplace, posters with tips on health and quality of life computer software\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors', 'otherNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exercise in the Workplace', 'description': 'Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Educational Intervention', 'description': 'This company received a quality of life software and poster with tips on health lifestyle.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control Company', 'description': 'No intervention. Control group received no intervention during study period', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise in the Workplace and Educational Intervention', 'description': 'Company A received exercise in the workplace, posters with tips on health and quality of life computer software\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG001', 'title': 'Exercise in the Workplace', 'description': 'Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG002', 'title': 'Educational Intervention', 'description': 'This company received a quality of life software and poster with tips on health lifestyle.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG003', 'title': 'Control Company', 'description': 'No intervention. Control group received no intervention during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '68.5', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '72', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '72', 'spread': '3.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The participants were followed for 3 months', 'description': 'The instrument contains 80 questions, of which 67 were structured in 5 points Lickert Scale. QVS-80 has four domains: Health Domain (Health) Physical activity (PA), occupational environment domain (AO) and perception of QoL (QOL). The health domain is composed of 30 questions, and the thirteen initial questions refer to history of the existence of chronic diseases such as hypertension, diabetes, obesity, dyslipidemias, bronchitis, allergic rhinitis and cancer; the remaining questions relate to lifestyle and living habits, such as quality of sleep, smoking and consumption of alcohol. The domain of physical activity consists of 15 questions on physical activity. The Domain workplace consists of 11 questions about the physical activity at work and occupational environment. The Domain perception of QoL consists of 24 questions about personal characteristics, and autonomy. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Activity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise in the Workplace and Educational Intervention', 'description': 'Company A received exercise in the workplace, posters with tips on health and quality of life computer software\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG001', 'title': 'Exercise in the Workplace', 'description': 'Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG002', 'title': 'Educational Intervention', 'description': 'This company received a quality of life software and poster with tips on health lifestyle.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG003', 'title': 'Control Company', 'description': 'No intervention. Control group received no intervention during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '27', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '36', 'spread': '7.2', 'groupId': 'OG002'}, {'value': '36', 'spread': '8.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The participants were followed for 3 months', 'description': 'The level of physical activity was evaluated by the questionnaire of quality of life. (QVS-80). The physical activity domain is composed of 15 questions considering the ammount of physical activity practiced during leisure time. The instrument is structured in 5 points Lickert Scale. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occupational Environment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise in the Workplace and Educational Intervention', 'description': 'Company A received exercise in the workplace, posters with tips on health and quality of life computer software\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG001', 'title': 'Exercise in the Workplace', 'description': 'Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG002', 'title': 'Educational Intervention', 'description': 'This company received a quality of life software and poster with tips on health lifestyle.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG003', 'title': 'Control Company', 'description': 'No intervention. Control group received no intervention during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '65', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '45', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '52', 'spread': '4.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The participants were followed for 3 months', 'description': 'The occupational environment was assessed by the quality of life questionnaire. (QVS-80). It considers physical aspects like accessibility and psycologic aspects such as stress. The domain consists of 11 questions about occupational environment. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).', 'unitOfMeasure': 'units on a scale 0-100', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Disease Prevalence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise in the Workplace and Educational Intervention', 'description': 'Company A received exercise in the workplace, posters with tips on health and quality of life computer software\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG001', 'title': 'Exercise in the Workplace', 'description': 'Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG002', 'title': 'Educational Intervention', 'description': 'This company received a quality of life software and poster with tips on health lifestyle.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG003', 'title': 'Control Company', 'description': 'No intervention. Control group received no intervention during study period'}], 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Overweight', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'Dislipedemy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Asthma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Thyreopathy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The participants were followed for 3 months', 'description': 'the changes in disease prevalence was measured in the same instrument QVS-80. The chronic disease was self-related by the participants.', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Perception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise in the Workplace and Educational Intervention', 'description': 'Company A received exercise in the workplace, posters with tips on health and quality of life computer software\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG001', 'title': 'Exercise in the Workplace', 'description': 'Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG002', 'title': 'Educational Intervention', 'description': 'This company received a quality of life software and poster with tips on health lifestyle.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'OG003', 'title': 'Control Company', 'description': 'No intervention. Control group received no intervention during study period'}], 'classes': [{'categories': [{'measurements': [{'value': '2.29', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '5.99'}, {'value': '3.74', 'groupId': 'OG001', 'lowerLimit': '1.16', 'upperLimit': '12.02'}, {'value': '0.94', 'groupId': 'OG002', 'lowerLimit': '0.38', 'upperLimit': '2.34'}, {'value': '1.07', 'groupId': 'OG003', 'lowerLimit': '0.34', 'upperLimit': '3.27'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The participants were followed for 3 months', 'description': 'Pain perception were evaluated by the diagram of pain proposed by Corlett in 1995. The part of body which had pain were indicated by the participant. The data were analysed as "yes" or "no" and reported as Odds ratio.', 'unitOfMeasure': 'Odds Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise in the Workplace and Educational Intervention', 'description': 'Company A received exercise in the workplace, posters with tips on health and quality of life computer software\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'FG001', 'title': 'Exercise in the Workplace', 'description': 'Exercise in the workplace was prescribed three times per week with fifteen minutes of duration. The exercises were mild.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'FG002', 'title': 'Educational Intervention', 'description': 'This company received a quality of life software and poster with tips on health lifestyle.\n\nExercise, Educational Intervention: Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors'}, {'id': 'FG003', 'title': 'Control Company', 'description': 'No intervention. Control group received no intervention during study period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Administrative workplace'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '190', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise in the Workplace and Educational Intervention', 'description': 'Participants received exercise in the workplace and educational intervention'}, {'id': 'BG001', 'title': 'Exercise in the Workplace', 'description': 'Participants received exercise only'}, {'id': 'BG002', 'title': 'Educational Intervention', 'description': 'Participants received educational intervention only'}, {'id': 'BG003', 'title': 'Control Company', 'description': 'Participants did not receive any intervention'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '190', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'spread': '3.54', 'groupId': 'BG000'}, {'value': '23.9', 'spread': '5.23', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '7.57', 'groupId': 'BG002'}, {'value': '27.2', 'spread': '7.7', 'groupId': 'BG003'}, {'value': '26', 'spread': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '190', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2011-11-28', 'resultsFirstSubmitDate': '2015-12-04', 'studyFirstSubmitQcDate': '2011-11-30', 'lastUpdatePostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-02', 'studyFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'The participants were followed for 3 months', 'description': 'The instrument contains 80 questions, of which 67 were structured in 5 points Lickert Scale. QVS-80 has four domains: Health Domain (Health) Physical activity (PA), occupational environment domain (AO) and perception of QoL (QOL). The health domain is composed of 30 questions, and the thirteen initial questions refer to history of the existence of chronic diseases such as hypertension, diabetes, obesity, dyslipidemias, bronchitis, allergic rhinitis and cancer; the remaining questions relate to lifestyle and living habits, such as quality of sleep, smoking and consumption of alcohol. The domain of physical activity consists of 15 questions on physical activity. The Domain workplace consists of 11 questions about the physical activity at work and occupational environment. The Domain perception of QoL consists of 24 questions about personal characteristics, and autonomy. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).'}], 'secondaryOutcomes': [{'measure': 'Physical Activity Level', 'timeFrame': 'The participants were followed for 3 months', 'description': 'The level of physical activity was evaluated by the questionnaire of quality of life. (QVS-80). The physical activity domain is composed of 15 questions considering the ammount of physical activity practiced during leisure time. The instrument is structured in 5 points Lickert Scale. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).'}, {'measure': 'Occupational Environment', 'timeFrame': 'The participants were followed for 3 months', 'description': 'The occupational environment was assessed by the quality of life questionnaire. (QVS-80). It considers physical aspects like accessibility and psycologic aspects such as stress. The domain consists of 11 questions about occupational environment. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).'}, {'measure': 'Changes in Disease Prevalence', 'timeFrame': 'The participants were followed for 3 months', 'description': 'the changes in disease prevalence was measured in the same instrument QVS-80. The chronic disease was self-related by the participants.'}, {'measure': 'Pain Perception', 'timeFrame': 'The participants were followed for 3 months', 'description': 'Pain perception were evaluated by the diagram of pain proposed by Corlett in 1995. The part of body which had pain were indicated by the participant. The data were analysed as "yes" or "no" and reported as Odds ratio.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Physical Activity', 'Occupational Health', 'Quality of Life', 'Health Promotion'], 'conditions': ['Health Behavior']}, 'descriptionModule': {'briefSummary': 'The goal of this research was to investigate different intervention strategies in the workplace and their impact on quality of life of workers from companies in the city of Londrina, Parana, Brazil.\n\nThe interventions were composed by exercise in the workplace and educational interventions.', 'detailedDescription': 'The workplace has special features about human behaviors. Studies (Shepard 1996, Pratt 2008) has shown that workers participate of this kind of health promotion programs for various reasons: One reason is the convenience of doing something without having to look for it; another reason is group support, many workers who share difficulties due to their working demands can find support in each other, so that they could change health behavior. Furthermore there are patterns of formal and informal communication that can contribute to help more people to become healthier making their environment better. Finally, the norms of a corporate behavior can unite the group of workers seeking same objectives.\n\nAdditionally the literature has shown that adults increased workload, job insecurity and pressure to perform tasks (Sparks 1997). These facts has been shown that workplace is different from community based interventions and leisure interventions.\n\nThe outcomes proposed to study are different from other studies since the interventions focus changes in behaviors. Sedentary behavior has shown to have 23% of deaths from major chronic disease (WHO 2002).\n\nAs the populations rises around the world and with the prolonged life expectancies, the number of people with chronic diseases will raise (WHO 2006). By having positive changes in health behavior the costs of public health can be reduced. Studying different types of interventions and testing its efficacy in different places can help the policy makers to create healthier environments.\n\nThere are strategies being developed in the workplace, but its efficacy is being challenged. There are some researches that show no evidence to prove the continuity of these interventions and there are evidences proving the opposite, positive changes in clinical outcomes as diabetes, blood pressure and elevated blood cholesterol. In addition some measures as BMI, anthropometric, fitness level have shown good association as prediction of development of chronic disease with low cost (Dishman 2004).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria The inclusion criteria for participation of these study were never participated of and quality of life and health intervention program at work and had an interest in participating in the study. Included workers ≥ 18years who had to work in the office position, sitting at the computer most of the work shift.\n\nExclusion criteria: temporary workers and freelancers.'}, 'identificationModule': {'nctId': 'NCT01484834', 'briefTitle': 'Comparison of Interventions to Promote Health in Workers', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Metodista de Piracicaba'}, 'officialTitle': 'Comparison of Interventions to Promote Health in Workers: A Cluster Randomized Controled Trial', 'orgStudyIdInfo': {'id': 'UMetodistaPiracicaba-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise and Education', 'description': 'Company A received intervention of exercise in the workplace, posters with tips on health and quality of life computer software. The interventions with physical exercise in the workplace, were performed in the morning shift and had duration of three months with 15 minutes each and were applied three times per week every other day. In order to keep the workers motivated and participating in the exercise in the workplace, the sessions were very varied, using broomstick, latex tubes, exercises in pairs, massage, sitting exercises and relaxation on mats.', 'interventionNames': ['Behavioral: Exercise and Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'The intervention with physical exercise in the workplace, were performed in the morning shift and had duration of three months with 15 minutes each and were applied three times per week every other day. In order to keep the workers motivated and participating in the exercise in the workplace, the sessions were very varied, using broomstick, latex tubes, exercises in pairs, massage, sitting exercises and relaxation on mats.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational Intervention', 'description': 'This company received a quality of life software and poster intervention with tips on health lifestyle. The posters were printed in A3 paper and eight of them were put up per month in different parts of the companies (near water fountains, rest places, cafeterias, near the restrooms and change rooms). The used messages, both by the posters and the software were basedon scientific evidence related to quality of life and health', 'interventionNames': ['Behavioral: Educational Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Company', 'description': 'No intervention', 'interventionNames': ['Other: Control Company']}], 'interventions': [{'name': 'Exercise and Education', 'type': 'BEHAVIORAL', 'otherNames': ['Worksite interventions', 'Physical activity at the workplace'], 'description': 'Exercise were prescribed three times a week with duration of fifteen minutes for three months.\n\nEducational Intervention were composed by a quality of life computer software and poster with tips on health behaviors', 'armGroupLabels': ['Exercise and Education']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Worksite interventions', 'Physical activity at the workplace'], 'description': 'Exercise were prescribed three times a week with duration of fifteen minutes for three months.', 'armGroupLabels': ['Exercise']}, {'name': 'Educational Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Worksite interventions', 'Physical activity at the workplace'], 'description': 'This company received a quality of life software and poster intervention with tips on health lifestyle. The posters were printed in A3 paper and eight of them were put up per month in different parts of the companies (near water fountains, rest places, cafeterias, near the restrooms and change rooms). The used messages, both by the posters and the software were basedon scientific evidence related to quality of life and health', 'armGroupLabels': ['Educational Intervention']}, {'name': 'Control Company', 'type': 'OTHER', 'description': 'No intervention was applied for the participants of this group', 'armGroupLabels': ['Control Company']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13400-911', 'city': 'Piracicaba', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Metodista de Piracicaba', 'geoPoint': {'lat': -22.72528, 'lon': -47.64917}}], 'overallOfficials': [{'name': 'Antonio J Grande, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Metodista de Piracicaba'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data are available when required'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Metodista de Piracicaba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio Jose Grande', 'investigatorAffiliation': 'Universidade Metodista de Piracicaba'}}}}