Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-03-14 @ 10:40 PM
Study NCT ID:
NCT03190135
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2017-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the BOKS Before-school Physical Activity Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-15', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Body Mass Index at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Body Mass Index (kg/m\\^2): calculated from height and weight'}, {'measure': 'Change from baseline Body Mass Index Z-score at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Age- and sex- specific Body Mass Index Z-score'}], 'secondaryOutcomes': [{'measure': 'Change from baseline 400 meter run time at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Time (seconds) to complete a 400 meter run'}, {'measure': 'Change from baseline physical activity at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Days per week of physical activity'}, {'measure': 'Change from baseline peer relationships at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'PROMIS validated scale'}, {'measure': 'Change from baseline positive affect at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'PROMIS validated scale'}, {'measure': 'Change from baseline life satisfaction at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'PROMIS validated scale'}, {'measure': 'Change from baseline vitality/energy at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Healthy Pathways Child-Report Scales'}, {'measure': 'Change from baseline student engagement at 12 weeks', 'timeFrame': 'baseline, 12 weeks', 'description': 'Healthy Pathways Child-Report Scales'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'School', 'Physical Activity'], 'conditions': ['Overweight and Obesity', 'Affect', 'Physical Activity', 'Fitness']}, 'referencesModule': {'references': [{'pmid': '27339866', 'type': 'BACKGROUND', 'citation': 'Pojednic R, Peabody S, Carson S, Kennedy M, Bevans K, Phillips EM. The effect of before school physical activity on child development: A study protocol to evaluate the Build Our Kids Success (BOKS) Program. Contemp Clin Trials. 2016 Jul;49:103-8. doi: 10.1016/j.cct.2016.06.009. Epub 2016 Jun 23.'}, {'pmid': '29449135', 'type': 'DERIVED', 'citation': 'Whooten RC, Perkins ME, Gerber MW, Taveras EM. Effects of Before-School Physical Activity on Obesity Prevention and Wellness. Am J Prev Med. 2018 Apr;54(4):510-518. doi: 10.1016/j.amepre.2018.01.017. Epub 2018 Feb 12.'}]}, 'descriptionModule': {'briefSummary': "BOKS, Build Our Kids' Success, is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Students participate in the program for 12 weeks, two or three mornings per week for about 1 hour per session. This study if a non-randomized control trial seeking to 1) examine the extent to which participation in the before-school BOKS program improves, health, well-being, and performance, and 2) compare the results of a two-day-per-week versus a three-day-per-week program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participating school\n* Child age 5-14 years\n\nExclusion Criteria:\n\n* No valid parental consent\n* Missing group assignment'}, 'identificationModule': {'nctId': 'NCT03190135', 'briefTitle': 'Evaluation of the BOKS Before-school Physical Activity Program', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': "Evaluation of the Build Our Kids' Success (BOKS) Before-school Physical Activity Program", 'orgStudyIdInfo': {'id': '2017P000177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BOKS: 2 day per week', 'interventionNames': ['Behavioral: BOKS: 2 day a week before-school physical activity program']}, {'type': 'EXPERIMENTAL', 'label': 'BOKS: 3 day per week', 'interventionNames': ['Behavioral: BOKS: 3 day a week before-school physical activity program']}, {'type': 'NO_INTERVENTION', 'label': 'Non-BOKS'}], 'interventions': [{'name': 'BOKS: 2 day a week before-school physical activity program', 'type': 'BEHAVIORAL', 'description': 'Students participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week.', 'armGroupLabels': ['BOKS: 2 day per week']}, {'name': 'BOKS: 3 day a week before-school physical activity program', 'type': 'BEHAVIORAL', 'description': 'Students participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week.', 'armGroupLabels': ['BOKS: 3 day per week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02360', 'city': 'Plymouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Plymouth Public Schools', 'geoPoint': {'lat': 41.95844, 'lon': -70.66726}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Quincy Public Schools', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}, {'zip': '02190', 'city': 'Weymouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Weymouth Public Schools', 'geoPoint': {'lat': 42.22093, 'lon': -70.93977}}], 'overallOfficials': [{'name': 'Elsie Taveras, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Reeboks BOKS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of General Academic Pediatrics', 'investigatorFullName': 'Elsie Taveras, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}