Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT01939405
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2013-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Children's Use of the Built Environment for Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'noreskovic@mgh.harvard.edu', 'phone': '6177260593', 'title': 'Dr. Nicolas Oreskovic', 'organization': 'MGH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size, single office setting, short term (4 months) follow-up, multi-component intervention including financial incentives and text messages.'}}, 'adverseEventsModule': {'description': 'The meaning of "0" Total Number of Participants at Risk (e.g., "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events) were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Physical Activity Counseling', 'description': 'standard pedatric physical activity counseling', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Built Environment Use Counseling', 'description': 'personalized counseling on active use of the built environment\n\nbuilt environment use counseling', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Moderate to Vigorous Physical Activity (MVPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Physical Activity Counseling', 'description': 'standard pedatric physical activity counseling'}, {'id': 'OG001', 'title': 'Built Environment Use Counseling', 'description': 'personalized counseling on active use of the built environment\n\nbuilt environment use counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'groupId': 'OG000', 'lowerLimit': '-14.1', 'upperLimit': '3.7'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '-14.7', 'upperLimit': '21.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately post-intervention', 'description': 'Short-term change in MVPA from baseline to post-intervention', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Moderate-to-Vigorous Physical Activity (MVPA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Physical Activity Counseling', 'description': 'standard pedatric physical activity counseling'}, {'id': 'OG001', 'title': 'Built Environment Use Counseling', 'description': 'personalized counseling on active use of the built environment\n\nbuilt environment use counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-22.7', 'upperLimit': '4.1'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '-31.1', 'upperLimit': '11.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months from baseline', 'description': 'Longer term change in MVPA from baseline to 3-4 months post intervention', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sedentary Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Physical Activity Counseling', 'description': 'standard pedatric physical activity counseling'}, {'id': 'OG001', 'title': 'Built Environment Use Counseling', 'description': 'personalized counseling on active use of the built environment\n\nbuilt environment use counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '73.9', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '86.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately post-intervention', 'description': 'Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sedentary Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Physical Activity Counseling', 'description': 'standard pedatric physical activity counseling'}, {'id': 'OG001', 'title': 'Built Environment Use Counseling', 'description': 'personalized counseling on active use of the built environment\n\nbuilt environment use counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.9', 'spread': '75.6', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '91.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months from baseline', 'description': 'Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Physical Activity Counseling', 'description': 'standard pedatric physical activity counseling'}, {'id': 'FG001', 'title': 'Built Environment Use Counseling', 'description': 'personalized counseling on active use of the built environment\n\nbuilt environment use counseling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Physical Activity Counseling', 'description': 'standard pediatric physical activity counseling'}, {'id': 'BG001', 'title': 'Built Environment Use Counseling', 'description': 'personalized counseling on active use of the built environment\n\nbuilt environment use counseling'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '12.2', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '11.9', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Multi/Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI percentile', 'classes': [{'categories': [{'measurements': [{'value': '94', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '94', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '94', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'BMI percentile', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'parental education', 'classes': [{'categories': [{'title': 'High School or less', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Associates degree or College', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Graduate Education', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2013-09-03', 'resultsFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2013-09-05', 'lastUpdatePostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-31', 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moderate to Vigorous Physical Activity (MVPA)', 'timeFrame': 'Immediately post-intervention', 'description': 'Short-term change in MVPA from baseline to post-intervention'}], 'secondaryOutcomes': [{'measure': 'Moderate-to-Vigorous Physical Activity (MVPA)', 'timeFrame': '4 months from baseline', 'description': 'Longer term change in MVPA from baseline to 3-4 months post intervention'}, {'measure': 'Sedentary Time', 'timeFrame': 'Immediately post-intervention', 'description': 'Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers'}, {'measure': 'Sedentary Time', 'timeFrame': '4 months from baseline', 'description': 'Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Overweight', 'Physical Activity', 'Built Environment', 'counseling'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '27235377', 'type': 'DERIVED', 'citation': 'Oreskovic NM, Winickoff JP, Perrin JM, Robinson AI, Goodman E. A Multimodal Counseling-Based Adolescent Physical Activity Intervention. J Adolesc Health. 2016 Sep;59(3):332-337. doi: 10.1016/j.jadohealth.2016.03.012. Epub 2016 May 24.'}]}, 'descriptionModule': {'briefSummary': "The study aims are to develop and test the feasibility of a pediatric physical activity intervention that incorporates personal information on use of the built environment, and test the intervention's preliminary efficacy at increasing physical activity. The investigators hypothesize that it will be feasible to incorporate and measure changes in empiric GIS (geographic information system), GPS (global positioning system), and accelerometer feedback in the office setting as demonstrated by: i) Completeness of GPS and accelerometer data collection (primary measure of feasibility), ii) Participation rates among adolescents in the intervention group compared to the control group, and iii) Acceptability to patients as measured by adolescent satisfaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adolescents ages 10-16 years\n* BMI \\> 85th percentile for age and sex\n\nExclusion Criteria:\n\n* Physical conditions impairing ambulation\n* Adolescents who do not speak English\n* Adolescents who have missed more than 2 scheduled doctor's appointments during the past 5 years\n* Adolescents who are receiving any other form of physical activity counseling/intervention at the time of enrollment"}, 'identificationModule': {'nctId': 'NCT01939405', 'acronym': 'CUBES', 'briefTitle': "Children's Use of the Built Environment for Physical Activity", 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Use of the Built Environment to Promote Physical Activity in Children.', 'orgStudyIdInfo': {'id': '2010P001480'}, 'secondaryIdInfos': [{'id': 'K23HL103841', 'link': 'https://reporter.nih.gov/quickSearch/K23HL103841', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard physical activity counseling'}, {'type': 'EXPERIMENTAL', 'label': 'built environment use counseling', 'description': 'personalized counseling on active use of the built environment', 'interventionNames': ['Behavioral: built environment use counseling']}], 'interventions': [{'name': 'built environment use counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['built environment use counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02151', 'city': 'Revere', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Revere HealthCare Center', 'geoPoint': {'lat': 42.40843, 'lon': -71.01199}}], 'overallOfficials': [{'name': 'Nicolas M Oreskovic, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Nicolas M. Oreskovic, MD, MPH', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}