Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-05 @ 1:07 PM
Study NCT ID:
NCT02810834
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2015-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding the Impact of School-Based Physical Activity Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'School-time and total daily MVPA', 'timeFrame': '5 months and 1.5 years', 'description': 'Changes in minutes of school-time and total daily moderate-to-vigorous physical activity (MVPA) among third-fifth graders participating in innovative school-based physical activity programs, compared to controls'}], 'secondaryOutcomes': [{'measure': 'Cognitive performance', 'timeFrame': '5 months and 1.5 years', 'description': 'Changes in cognitive performance, as measured by standard tests of executive function, among third-fifth graders participating in innovative'}, {'measure': 'Academic achievement', 'timeFrame': '5 months and 1.5 years', 'description': 'Changes in academic achievement, as measured by standardized tests (English language art and math), among third-fifth graders participating in innovative'}]}, 'conditionsModule': {'keywords': ['Executive Function', 'Academic Performance'], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '34555181', 'type': 'DERIVED', 'citation': 'Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.'}, {'pmid': '33781620', 'type': 'DERIVED', 'citation': "Sacheck JM, Wright CM, Amin SA, Anzman-Frasca S, Chomitz VM, Chui KK, Duquesnay PJ, Nelson ME, Economos CD. The Fueling Learning Through Exercise Study Cluster RCT: Impact on Children's Moderate-to-Vigorous Physical Activity. Am J Prev Med. 2021 Jun;60(6):e239-e249. doi: 10.1016/j.amepre.2021.01.002. Epub 2021 Mar 26."}, {'pmid': '30651117', 'type': 'DERIVED', 'citation': 'Wright CM, Chomitz VR, Duquesnay PJ, Amin SA, Economos CD, Sacheck JM. The FLEX study school-based physical activity programs - measurement and evaluation of implementation. BMC Public Health. 2019 Jan 16;19(1):73. doi: 10.1186/s12889-018-6335-3.'}, {'pmid': '29543115', 'type': 'DERIVED', 'citation': 'Amin SA, Duquesnay PJ, Wright CM, Chui K, Economos CD, Sacheck JM. The Association Between Perceived Athletic Competence and Physical Activity: Implications for Low-Income Schoolchildren. Pediatr Exerc Sci. 2018 Aug 1;30(3):433-440. doi: 10.1123/pes.2017-0242. Epub 2018 Mar 15.'}, {'pmid': '27737676', 'type': 'DERIVED', 'citation': "Wright CM, Duquesnay PJ, Anzman-Frasca S, Chomitz VR, Chui K, Economos CD, Langevin EG, Nelson ME, Sacheck JM. Study protocol: the Fueling Learning through Exercise (FLEX) study - a randomized controlled trial of the impact of school-based physical activity programs on children's physical activity, cognitive function, and academic achievement. BMC Public Health. 2016 Oct 13;16(1):1078. doi: 10.1186/s12889-016-3719-0."}]}, 'descriptionModule': {'briefSummary': 'The central hypothesis of the Fueling Learning Through Exercise (FLEX) study is two innovative school-based physical activity programs (a walking/running program and a classroom activity break program) will increase school-time and total daily minutes children engage in moderate-to-vigorous physical activity, relative to controls, and that children who attend schools with these PA programs will demonstrate improved cognitive functioning, academic achievement, and attendance, relative to controls.', 'detailedDescription': "The FLEX Study is a three-year, randomized control trial that seeks to understand how two different innovative school-based physical activity (PA) programs influence not only children's time spent in MVPA but also their cognitive and academic outcomes. The FLEX Study will be implemented and evaluated by researchers from Tufts University. The project is funded by the National Institutes of Health.\n\nSchools participating in the study will be randomly assigned to receive a walking/running program, a classroom physical activity program, or no program (control) during first year and a half of the study. Third and fourth grade children will be enrolled in the study.\n\nPhysical activity will be assessed objectively using accelerometry. Additional measurements will include: BMI/BMI-z (measured height and weight), diet and physical activity questionnaires, cognitive functioning (tests of working memory and inhibitory control)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren participants 3rd or 4th grade student in participating school (during first school year of study)\n\nExclusion Criteria:\n\nNot a 3rd or 4th grade student'}, 'identificationModule': {'nctId': 'NCT02810834', 'briefTitle': 'Understanding the Impact of School-Based Physical Activity Programs', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Understanding the Impact of School-Based Physical Activity Programs', 'orgStudyIdInfo': {'id': 'R01HD080180', 'link': 'https://reporter.nih.gov/quickSearch/R01HD080180', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01HD080180-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD080180-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Walking/Running Program', 'description': 'Walking/running/jogging program; school-based.', 'interventionNames': ['Behavioral: Walking/Running program']}, {'type': 'EXPERIMENTAL', 'label': 'Classroom activity break program', 'description': 'Classroom physical activity break program; school-based.', 'interventionNames': ['Behavioral: Classroom physical activity break program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control/Delayed Intervention'}], 'interventions': [{'name': 'Walking/Running program', 'type': 'BEHAVIORAL', 'otherNames': ['100 Mile Club'], 'description': 'Participants will receive a behavioral intervention that consists of a school-based, walking/running/jogging program. Participants work to accumulate miles towards a goal of at least 100 miles, over the course of the school year. Program will be implemented through a "champion" in the school and structured/scheduled according to the schools resources (before, during, or after school). Miles are tracked at the school level, and incentives are provided for participants\' completion of set milestones (25, 50, 75, and 100 miles).\n\nThe intervention will run over two school years (approximately 16 months)', 'armGroupLabels': ['Walking/Running Program']}, {'name': 'Classroom physical activity break program', 'type': 'BEHAVIORAL', 'otherNames': ['Just Move'], 'description': 'Participants will receive a behavioral intervention that consists of a classroom-based, physical activity break program. Classroom teachers, paraprofessionals, and other school staff will lead short (5-15 minute) activity breaks that include both higher intensity (ex. jumping jacks, squats) and low-intensity (ex. stretching, yoga) activities. Classrooms will be encouraged to integrate at least one short break per day. Activities are connected to national Common Core academic standards so that breaks can be integrated with academics.\n\nThe intervention will run over two school years (approximately 16 months)', 'armGroupLabels': ['Classroom activity break program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, Tufts University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jennifer M Sacheck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}