Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-01 @ 9:53 PM
Study NCT ID:
NCT01633918
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2012-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FeetEnergy Approach to Increase Physical Activity and Reduce Screen Time in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2012-06-27', 'studyFirstSubmitQcDate': '2012-06-29', 'lastUpdatePostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in meeting physical activity recommendation at 1 month', 'timeFrame': 'baseline and 1 month'}, {'measure': 'change from baseline in physical activity recommendation at 7 months', 'timeFrame': 'baseline and 7 months'}, {'measure': 'change from baseline in meeting screen time recommendation at 1 month', 'timeFrame': 'baseline and 1 month'}, {'measure': 'change from baseline in meeting screen time recommendation at 7 month', 'timeFrame': 'baseline and 7 month'}], 'secondaryOutcomes': [{'measure': 'change from baseline in psychosocial factors related to physical activity at 1 month', 'timeFrame': 'baseline and 1 month'}, {'measure': 'change from baseline in parental interference with physical activity of their child at 1 month', 'timeFrame': 'baseline and 1 month'}, {'measure': 'change from baseline in psychosocial factors related to screen time at 1 month', 'timeFrame': 'baseline and 1 month'}, {'measure': 'change from baseline in parental interference with screen time of their child at 1 month', 'timeFrame': 'baseline and 1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intervention', 'health education', 'physical activity', 'sedentary behavior', 'health promotion', 'evaluation', 'RE-AIM'], 'conditions': ['Physical Activity', 'Sedentary Behavior', 'Active Commuting', 'Psychosocial Factors', 'Parental Interference']}, 'referencesModule': {'references': [{'pmid': '30995905', 'type': 'DERIVED', 'citation': 'Aittasalo M, Jussila AM, Tokola K, Sievanen H, Vaha-Ypya H, Vasankari T. Kids Out; evaluation of a brief multimodal cluster randomized intervention integrated in health education lessons to increase physical activity and reduce sedentary behavior among eighth graders. BMC Public Health. 2019 Apr 17;19(1):415. doi: 10.1186/s12889-019-6737-x.'}, {'pmid': '26160058', 'type': 'DERIVED', 'citation': 'Jussila AM, Vasankari T, Paronen O, Sievanen H, Tokola K, Vaha-Ypya H, Broberg A, Aittasalo M. KIDS OUT! Protocol of a brief school-based intervention to promote physical activity and to reduce screen time in a sub-cohort of Finnish eighth graders. BMC Public Health. 2015 Jul 10;15:634. doi: 10.1186/s12889-015-2007-8.'}], 'seeAlsoLinks': [{'url': 'http://www.ukkinstituutti.fi', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to find out whether an Internet-supported FeetEnergy approach and two home works integrated in three health education lessons can increase adolescents' active commuting to school and leisure-time physical activity and decrease their screen time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* student's informed consent and an approval from his/her parent\n\nExclusion Criteria:\n\n* no informed consent from the student and no approval from his/her parent"}, 'identificationModule': {'nctId': 'NCT01633918', 'acronym': 'FeetEnergy', 'briefTitle': 'FeetEnergy Approach to Increase Physical Activity and Reduce Screen Time in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'UKK Institute'}, 'officialTitle': 'Integrating Internet-supported FeetEnergy Approach in Health Education Lessons to Increase Physical Activity and Reduce Screen Time in Adolescents', 'orgStudyIdInfo': {'id': '166,02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-supported FeetEnergy approach', 'description': 'Schools which integrate Internet-supported approach with two home works in three health education lessons on physical activity', 'interventionNames': ['Behavioral: Internet-supported FeetEnergy approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual health education', 'description': 'Schools which follow their usual practices in carrying out health education classes on physical activity', 'interventionNames': ['Behavioral: Usual health education']}], 'interventions': [{'name': 'Internet-supported FeetEnergy approach', 'type': 'BEHAVIORAL', 'description': "Three health education lessons and two homework's about increasing physical activity and reducing screen time", 'armGroupLabels': ['Internet-supported FeetEnergy approach']}, {'name': 'Usual health education', 'type': 'BEHAVIORAL', 'description': 'Usual health education lessons', 'armGroupLabels': ['Usual health education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00076', 'city': 'Espoo', 'state': 'Aalto', 'country': 'Finland', 'facility': 'Aalto University', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '33501', 'city': 'Tampere', 'country': 'Finland', 'facility': 'The UKK Institute for health Promotion Research', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Minna M Aittasalo, Dsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UKK Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UKK Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Education and Culture, Finland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Health Sciences', 'investigatorFullName': 'Minna Aittasalo', 'investigatorAffiliation': 'UKK Institute'}}}}