Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-03-03 @ 9:54 PM
Study NCT ID:
NCT01398059
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2011-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Metabolic Effects of Breaks in Sedentary Time
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trsaunders@upei.ca', 'phone': '902-566-0641', 'title': 'Dr. Travis Saunders', 'organization': 'University of Prince Edward Island'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Sedentary', 'description': 'In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.\n\nSedentary: In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sedentary With Breaks', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.\n\nSedentary With Breaks: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sedentary With Breaks and Physical Activity', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.\n\nSedentary With Breaks and Physical Activity: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary', 'description': 'In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.\n\nSedentary: In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.'}, {'id': 'OG001', 'title': 'Sedentary With Breaks', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.\n\nSedentary With Breaks: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.'}, {'id': 'OG002', 'title': 'Sedentary With Breaks and Physical Activity', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.\n\nSedentary With Breaks and Physical Activity: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.'}], 'classes': [{'categories': [{'measurements': [{'value': '80559.3', 'spread': '66380.3', 'groupId': 'OG000'}, {'value': '78707.3', 'spread': '83074.5', 'groupId': 'OG001'}, {'value': '64270.8', 'spread': '42272.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Insulin levels will be assessed multiple times throughout the day, and the resulting values will be used to calculate AUC.', 'unitOfMeasure': 'pmol/L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary', 'description': 'In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.\n\nSedentary: In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.'}, {'id': 'OG001', 'title': 'Sedentary With Breaks', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.\n\nSedentary With Breaks: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.'}, {'id': 'OG002', 'title': 'Sedentary With Breaks and Physical Activity', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.\n\nSedentary With Breaks and Physical Activity: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.8', 'spread': '114.4', 'groupId': 'OG000'}, {'value': '101.5', 'spread': '69.0', 'groupId': 'OG001'}, {'value': '65.2', 'spread': '66.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Blood draws will be taken several times throughout the day, and the resulting values will be used to calculate AUC.', 'unitOfMeasure': 'mmol/L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary', 'description': 'In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.\n\nSedentary: In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.'}, {'id': 'OG001', 'title': 'Sedentary With Breaks', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.\n\nSedentary With Breaks: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.'}, {'id': 'OG002', 'title': 'Sedentary With Breaks and Physical Activity', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.\n\nSedentary With Breaks and Physical Activity: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.7', 'spread': '39.9', 'groupId': 'OG000'}, {'value': '-32.2', 'spread': '40.2', 'groupId': 'OG001'}, {'value': '-52.3', 'spread': '41.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.', 'unitOfMeasure': 'mmol/L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary', 'description': 'In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.\n\nSedentary: In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.'}, {'id': 'OG001', 'title': 'Sedentary With Breaks', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.\n\nSedentary With Breaks: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.'}, {'id': 'OG002', 'title': 'Sedentary With Breaks and Physical Activity', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.\n\nSedentary With Breaks and Physical Activity: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.'}], 'classes': [{'categories': [{'measurements': [{'value': '-62.9', 'spread': '67.2', 'groupId': 'OG000'}, {'value': '-50.0', 'spread': '28.9', 'groupId': 'OG001'}, {'value': '-76.5', 'spread': '51.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.', 'unitOfMeasure': 'mmol/L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sedentary', 'description': 'In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.\n\nSedentary: In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.'}, {'id': 'OG001', 'title': 'Sedentary With Breaks', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.\n\nSedentary With Breaks: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.'}, {'id': 'OG002', 'title': 'Sedentary With Breaks and Physical Activity', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.\n\nSedentary With Breaks and Physical Activity: In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.'}], 'classes': [{'categories': [{'measurements': [{'value': '185.3', 'spread': '171.7', 'groupId': 'OG000'}, {'value': '163.2', 'spread': '148.8', 'groupId': 'OG001'}, {'value': '248.0', 'spread': '220.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.', 'unitOfMeasure': 'mmol/L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sed, Sed With Breaks, Sed With Breaks and PA', 'description': 'In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.\n\nSedentary condition\n\nSedentary with breaks condition\n\nSedentary with breaks and physical activity condition'}, {'id': 'FG001', 'title': 'Sed, Sed With Breaks and PA, Sed With Breaks', 'description': 'In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.\n\nSedentary condition\n\nSedentary with breaks and physical activity condition\n\nSedentary with breaks condition'}, {'id': 'FG002', 'title': 'Sed With Breaks, Sed With Breaks and PA, Sed', 'description': 'In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.\n\nSedentary with breaks and physical activity condition\n\nSedentary with breaks condition\n\nSedentary condition'}, {'id': 'FG003', 'title': 'Sed With Breaks, Sed, Sed With Breaks and PA', 'description': 'In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.\n\nSedentary with breaks condition\n\nSedentary condition\n\nSedentary with breaks and physical activity condition'}, {'id': 'FG004', 'title': 'Sed With Breaks and PA, Sed, Sed With Breaks', 'description': 'In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.\n\nSedentary with breaks and physical activity condition\n\nSedentary condition\n\nSedentary with breaks condition'}, {'id': 'FG005', 'title': 'Sed With Breaks and PA, Sed With Breaks, Sed', 'description': 'In this condition, participants experienced the experimental conditions in the following order. Each condition was separated by at least 1 week.\n\nSedentary with breaks and physical activity condition\n\nSedentary with breaks condition\n\nSedentary condition'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All participants experienced all 3 conditions, in random order.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index calculated using height and weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist circumference measured in cm', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimetres', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pubertal stage measured by self-reported Tanner stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Tanner stages are a scale of physical development in children, adolescents and adults. The scale ranges from 1 (pre-pubescent child) to 5 (adult), and defines physical measurements of development based on external primary and secondary sex characteristics, such as the size of the breasts, genitals, testicular volume and development of pubic hair.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline PA level by Actical Accelerometer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Sedentary Behaviour by Actical Accelerometer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '507', 'spread': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glucose', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL-Cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL-Cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-22', 'studyFirstSubmitDate': '2011-07-18', 'resultsFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-22', 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Insulin levels will be assessed multiple times throughout the day, and the resulting values will be used to calculate AUC.'}], 'secondaryOutcomes': [{'measure': 'Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Blood draws will be taken several times throughout the day, and the resulting values will be used to calculate AUC.'}, {'measure': 'Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.'}, {'measure': 'Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.'}, {'measure': 'Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)', 'timeFrame': 'Baseline, 1.5, 3, 4.5, 6, and 7.5 hours', 'description': 'Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sedentary Behavior', 'Cardiometabolic Risk', 'Pediatrics'], 'conditions': ['Feasibility', 'Insulin', 'Glucose', 'Lipids', 'Eating']}, 'referencesModule': {'references': [{'pmid': '23773981', 'type': 'RESULT', 'citation': 'Saunders TJ, Chaput JP, Goldfield GS, Colley RC, Kenny GP, Doucet E, Tremblay MS. Prolonged sitting and markers of cardiometabolic disease risk in children and youth: a randomized crossover study. Metabolism. 2013 Oct;62(10):1423-8. doi: 10.1016/j.metabol.2013.05.010. Epub 2013 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether acute bouts of sedentary behaviour (with or without breaks and/or structured physical activity) result in measurable changes in metabolic health in children and youth.', 'detailedDescription': 'North American children spend the majority of their waking hours engaging in sedentary behavior (e.g. sitting). Research in adults and animal models suggests that even short bouts of uninterrupted siting may result in acute changes increases in cardiometabolic risk, although to date no studies have investigated this relationship in children and youth. The purpose of this study is to assess the feasibility of a protocol which will expose participants aged 10-14 years to a full day of uninterrupted sitting, and to determine the impact of this protocol on markers of cardiometabolic risk (insulin, glucose, triglyceride, HDL-C and LDL-C) as well as subsequent food intake and physical activity. The impact of uninterrupted sitting will be compared to the impact of interrupted sitting, with and without the inclusion of moderate physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 10-14\n* Normal weight or obese\n\nExclusion Criteria:\n\n* Overweight\n* Overt diabetes or heart disease (or taking medications to treat this conditions)\n* Being unambulatory or otherwise unable to perform the study protocol'}, 'identificationModule': {'nctId': 'NCT01398059', 'briefTitle': 'The Metabolic Effects of Breaks in Sedentary Time', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Eastern Ontario"}, 'officialTitle': 'The Metabolic Effects of Breaks in Sedentary Time', 'orgStudyIdInfo': {'id': '11/01E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sedentary', 'description': 'In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.', 'interventionNames': ['Other: Sedentary']}, {'type': 'EXPERIMENTAL', 'label': 'Sedentary With Breaks', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.', 'interventionNames': ['Other: Sedentary With Breaks']}, {'type': 'EXPERIMENTAL', 'label': 'Sedentary With Breaks and Physical Activity', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.', 'interventionNames': ['Other: Sedentary With Breaks and Physical Activity']}], 'interventions': [{'name': 'Sedentary', 'type': 'OTHER', 'description': 'In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.', 'armGroupLabels': ['Sedentary']}, {'name': 'Sedentary With Breaks', 'type': 'OTHER', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.', 'armGroupLabels': ['Sedentary With Breaks']}, {'name': 'Sedentary With Breaks and Physical Activity', 'type': 'OTHER', 'description': 'In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.', 'armGroupLabels': ['Sedentary With Breaks and Physical Activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1N 6N5', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Behavioural Metabolic Research Unit, University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Mark S Tremblay, OhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Eastern Ontario Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Eastern Ontario", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ottawa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Mark Tremblay, Director, Healthy Active Living and Obesity Research Group', 'investigatorFullName': 'Mark Tremblay', 'investigatorAffiliation': "Children's Hospital of Eastern Ontario"}}}}