Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-04 @ 8:45 AM
Study NCT ID:
NCT02560493
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2015-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gaming Technology to Encourage Healthy Weight and Activity in Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amanda.staiano@pbrc.edu', 'phone': '2257632869', 'title': 'Dr. Amanda Staiano', 'organization': "LSU's Pennington Biomedical Research Center"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 2, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injury during game play', 'notes': 'Bruise to the ankle or wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'OG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': "Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Changes in Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'OG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'A dual energy x-ray absorptiometry (DXA) scan will be completed at Week 0 and Week 24 with a GE iDXA whole-body scanner (GE Medical Systems, Milwaukee, WI) to measure adiposity, including total body fat mass and regional fat mass in the extremities and trunk.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Changes in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'OG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': "Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated.", 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Changes in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'OG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': "Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated.", 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Changes in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'OG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of total cholesterol will be assayed on a DXC600 from Trinity.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Changes in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'OG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of glucose will be obtained from a DXC600 by Beckman Coulter.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant was lost to follow-up.'}, {'type': 'SECONDARY', 'title': 'Changes in Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'OG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'Physical activity will be assessed with an Actigraph GT3X+ accelerometer (ActiGraph, of Ft. Walton Beach, FL) to determine changes in habitual physical activity outside of the gaming intervention. Participants will wear the accelerometer for two bouts of 7-days following Week 0 baseline clinic visit and Week 24 clinic visit, but not during the gaming intervention.', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Several participants did not meet criteria for complete accelerometry data (at least 4 days of 10 hours/day including 1 weekend day) at both time points.'}, {'type': 'SECONDARY', 'title': 'Changes in Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'OG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}], 'classes': [{'categories': [{'measurements': [{'value': '269.5', 'spread': '200.0', 'groupId': 'OG000'}, {'value': '-297.2', 'spread': '215.0', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'Dietary information will be collected from the participant at Week 0 and Week 24. Healthy diet score will be determined by the NCI Self-administered 24-hour Dietary Recall (ASA24-Kids). This survey is administered on a computer through a web-based program.', 'unitOfMeasure': 'kcal/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants did not complete the dietary recalls.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'FG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'id': 'BG001', 'title': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.\n\nExergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '11.3', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '11.2', 'spread': '0.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index, z-score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.42', 'groupId': 'BG000'}, {'value': '2.06', 'spread': '0.46', 'groupId': 'BG001'}, {'value': '2.08', 'spread': '0.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean', 'unitOfMeasure': 'z-score.', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fat mass, kg', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.3', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '30.4', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '29.8', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fat mass percentage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44.1', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '42.0', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '43.1', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of fat mass', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure percentile', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43.7', 'spread': '25.9', 'groupId': 'BG000'}, {'value': '36.4', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '40.0', 'spread': '23.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentile', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure percentile', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.3', 'spread': '22.4', 'groupId': 'BG000'}, {'value': '58.5', 'spread': '17.8', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '20.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentile', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL-cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.3', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '48.9', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '50.1', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL-cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '99.3', 'spread': '29.6', 'groupId': 'BG000'}, {'value': '89.4', 'spread': '31.2', 'groupId': 'BG001'}, {'value': '94.4', 'spread': '30.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Moderate-to-vigorous physical activity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35.1', 'spread': '18.3', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '17.8', 'groupId': 'BG001'}, {'value': '35.1', 'spread': '17.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes/day', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "One participant's accelerometry data did not meet standards for completeness (10 hours/day with at least 4 days/week including 1 weekend day)."}, {'title': 'Reported dietary intake', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1894.4', 'spread': '881.2', 'groupId': 'BG000'}, {'value': '1700.0', 'spread': '905.4', 'groupId': 'BG001'}, {'value': '1801.8', 'spread': '887.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kcal/day', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Some participants did not provide complete data on the dietary recall and were not included in these analyses.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2015-09-18', 'resultsFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2015-09-23', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-15', 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': "Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean"}], 'secondaryOutcomes': [{'measure': 'Changes in Body Fat', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'A dual energy x-ray absorptiometry (DXA) scan will be completed at Week 0 and Week 24 with a GE iDXA whole-body scanner (GE Medical Systems, Milwaukee, WI) to measure adiposity, including total body fat mass and regional fat mass in the extremities and trunk.'}, {'measure': 'Changes in Systolic Blood Pressure', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': "Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated."}, {'measure': 'Changes in Diastolic Blood Pressure', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': "Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated."}, {'measure': 'Changes in Total Cholesterol', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of total cholesterol will be assayed on a DXC600 from Trinity.'}, {'measure': 'Changes in Fasting Glucose', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of glucose will be obtained from a DXC600 by Beckman Coulter.'}, {'measure': 'Changes in Physical Activity', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'Physical activity will be assessed with an Actigraph GT3X+ accelerometer (ActiGraph, of Ft. Walton Beach, FL) to determine changes in habitual physical activity outside of the gaming intervention. Participants will wear the accelerometer for two bouts of 7-days following Week 0 baseline clinic visit and Week 24 clinic visit, but not during the gaming intervention.'}, {'measure': 'Changes in Diet', 'timeFrame': 'Change between Baseline (Week 0) and 6 months (Week 24)', 'description': 'Dietary information will be collected from the participant at Week 0 and Week 24. Healthy diet score will be determined by the NCI Self-administered 24-hour Dietary Recall (ASA24-Kids). This survey is administered on a computer through a web-based program.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BMIz', 'Exergaming', 'Cardiovascular Disease'], 'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '30027607', 'type': 'BACKGROUND', 'citation': 'Staiano AE, Beyl RA, Guan W, Hendrick CA, Hsia DS, Newton RL Jr. Home-based exergaming among children with overweight and obesity: a randomized clinical trial. Pediatr Obes. 2018 Nov;13(11):724-733. doi: 10.1111/ijpo.12438. Epub 2018 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children.', 'detailedDescription': "The GAMESQUAD study is a 6-month, 2-arm randomized controlled trial among 46 overweight/obese children (aged 10 to 12 years) assigned to: 1) 3 hours/week of in-home exergaming or 2) a control group. An innovative aspect is the inclusion of a fitness trainer who will regularly video chat with the participant and virtually monitor gameplay. The study will advance the field by: 1) establishing the efficacy of exergaming to reduce BMIz among overweight and obese children and 2) demonstrating the potential of exergaming to reduce body fat and improve children's cardiovascular health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI percentile \\> or equal to 85 on the CDC growth chart\n* Participating household has a high-speed internet connection\n* At least 1 family member or friend who is willing to exergame in the home with the participant for 3 hours/week\n\nExclusion Criteria:\n\n* Pregnant\n* Impairments that prevent normal ambulation\n* Previous history, or current symptoms of, cardiovascular disease, musculoskeletal injury, or epileptic seizures'}, 'identificationModule': {'nctId': 'NCT02560493', 'acronym': 'GameSquad', 'briefTitle': 'Gaming Technology to Encourage Healthy Weight and Activity in Youth', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Gaming Technology to Encourage Healthy Weight and Activity in Youth', 'orgStudyIdInfo': {'id': 'PBRC 2015-037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Condition', 'description': 'Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff.'}, {'type': 'EXPERIMENTAL', 'label': 'Exergaming Condition', 'description': 'Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention.', 'interventionNames': ['Behavioral: Exergaming Condition']}], 'interventions': [{'name': 'Exergaming Condition', 'type': 'BEHAVIORAL', 'description': 'Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.', 'armGroupLabels': ['Exergaming Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Amanda E Staiano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amanda Staiano', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}