Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT03885518
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2019-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Painted Playgrounds: Aim 2: Assessments
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], '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': '225.763.2500', 'title': 'Dr. Amanda Staiano', 'organization': "LSU's Pennington Biomedical Research Center"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations include the small sample for this pilot study. Only four schools were examined in one region of the United States, so results may only be generalizable to this area or to programs with similar characteristics. The limited access to concrete space in most ECE centers is a limitation that must be considered for the expansion of this intervention.'}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'The children attending childcare centers randomized to this arm will have their physical activity and motor skills assessed; observations will be completed at baseline and 6-8 weeks after stencil activities have been painted at their center.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'The children attending childcare centers randomized to this arm will have their physical activity and motor skills assessed; these centers will NOT have the stencils and their observations will still be completed at baseline and 6-8 weeks after baseline.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Moderate to Vigorous Activity (MVPA) During Recess', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants attending the childcare centers randomized to this arm will receive the stencil activities after baseline assessments have been completed. We will follow-up with assessments after 6-8 weeks\n\nPlayground Stencils: The stencils (hopscotch, agility trail, foursquare, bullseye, etc.) will be painted on the playgrounds at each childcare center. A toolkit and training video will be distributed to staff at each center to aid in instructing the children on how to perform the tasks.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The children attending childcare centers randomized to this arm will have their physical activity and motor skills assessed; these centers will NOT have the stencils and their observations will still be completed at baseline and 6-8 weeks after baseline.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and follow-up (6 to 8 weeks after playground stenciling)', 'description': 'To test the effectiveness of a promising (cost-effective, easily scalable) playground stenciling intervention to increase physical activity, change in MVPA during recess will be measured using accelerometers. The main outcome variable will be percentage of recess time spent in MVPA, measured objectively using a physical activity monitor (i.e. accelerometer).', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Fundamental Motor Skill Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'The children attending childcare centers randomized to this arm will have their physical activity and motor skills assessed; observations will be completed at baseline and 6-8 weeks after stencil activities have been painted at their center.'}, {'id': 'OG001', 'title': 'Control', 'description': 'The children attending childcare centers randomized to this arm will have their physical activity and motor skills assessed; these centers will NOT have the stencils and their observations will still be completed at baseline and 6-8 weeks after baseline.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.2', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '25.8', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '37.7', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '34.1', 'spread': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and follow-up (6 to 8 weeks after playground stenciling)', 'description': 'The Test of Gross Motor Development, 3rd edition (TGMD-3) was utilized to assess fundamental motor skills. The test consists of a total of 13 skills which are designed to assess locomotor (6 skills) and ball (7 skills). Children complete two trials, and if they meet the specified performance criteria, they are scored a 1. If they fail to meet the criteria, they are scored a zero. Trials 1 and 2 are added to get the raw scores of locomotor and ball skill. For locomotor, this range is from 0-46; for ball skills, children can score from 0-54. Raw scores are then converted to scaled scores based on the TGMD-3 age and gender charts. The scaled scores are added to determine a total scaled score. The total scaled score has a percentile ranking to determine what percentile the child is in (\\<1,\\>99). The post-TGMD-3 total percentile was subtracted for the change score from the baseline percentile. A positive value indicates an improvement in fundamental motor skills, where', 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'The children attending childcare centers randomized to this arm will have their physical activity and motor skills assessed; observations will be completed at baseline and 6-8 weeks after stencil activities have been painted at their center.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'The children attending childcare centers randomized to this arm will have their physical activity and motor skills assessed; these centers will NOT have the stencils and their observations will still be completed at baseline and 6-8 weeks after baseline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Participants attending the childcare centers randomized to this arm will receive the stencil activities after baseline assessments have been completed. We will follow-up with assessments after 6-8 weeks\n\nPlayground Stencils: The stencils (hopscotch, agility trail, foursquare, bullseye, etc.) will be painted on the playgrounds at each childcare center. A toolkit and training video will be distributed to staff at each center to aid in instructing the children on how to perform the tasks.'}, {'id': 'BG001', 'title': 'Contorol', 'description': 'The children attending childcare centers randomized to this arm will have their physical activity and motor skills assessed; observations will be completed at baseline and 6-8 weeks after stencil activities have been painted at their center.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '51', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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': '23', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-14', 'size': 169441, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-19T12:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2019-01-29', 'resultsFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-05', 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Moderate to Vigorous Activity (MVPA) During Recess', 'timeFrame': 'Baseline and follow-up (6 to 8 weeks after playground stenciling)', 'description': 'To test the effectiveness of a promising (cost-effective, easily scalable) playground stenciling intervention to increase physical activity, change in MVPA during recess will be measured using accelerometers. The main outcome variable will be percentage of recess time spent in MVPA, measured objectively using a physical activity monitor (i.e. accelerometer).'}, {'measure': 'Change in Fundamental Motor Skill Development', 'timeFrame': 'Baseline and follow-up (6 to 8 weeks after playground stenciling)', 'description': 'The Test of Gross Motor Development, 3rd edition (TGMD-3) was utilized to assess fundamental motor skills. The test consists of a total of 13 skills which are designed to assess locomotor (6 skills) and ball (7 skills). Children complete two trials, and if they meet the specified performance criteria, they are scored a 1. If they fail to meet the criteria, they are scored a zero. Trials 1 and 2 are added to get the raw scores of locomotor and ball skill. For locomotor, this range is from 0-46; for ball skills, children can score from 0-54. Raw scores are then converted to scaled scores based on the TGMD-3 age and gender charts. The scaled scores are added to determine a total scaled score. The total scaled score has a percentile ranking to determine what percentile the child is in (\\<1,\\>99). The post-TGMD-3 total percentile was subtracted for the change score from the baseline percentile. A positive value indicates an improvement in fundamental motor skills, where'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '37689622', 'type': 'BACKGROUND', 'citation': "Webster EK, Kepper MM, Saha S, Beyl RA, Kracht CL, Romain JS, Staiano AE. Painted playgrounds for preschoolers' physical activity and fundamental motor skill improvement: a randomized controlled pilot trial of effectiveness. BMC Pediatr. 2023 Sep 9;23(1):455. doi: 10.1186/s12887-023-04260-2."}]}, 'descriptionModule': {'briefSummary': "The Painted Playgrounds Aim 2 (Assessment) project will examine the effects of a stenciling intervention aimed at increasing physical activity and improving fundamental motor skill functioning of preschool aged children. 72 children from local licensed childcare centers will participate in individual assessments at baseline and follow-up 6-8 weeks later. Assessments include height/weight, surveys and wearing a physical activity monitor (accelerometer) for 7 days. A parent/legal guardian will provide consent for their child to participate and will also complete a brief survey about their child's lifestyle and habits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A child who attends a childcare center enrolled to Aim 1.\n* A child who is ≥ 3 years and ≤ 6 years old\n* Your child will continue to attend this same childcare center for the duration of the study.\n\nExclusion Criteria:\n\n• Parent/legal guardian is unwilling to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT03885518', 'briefTitle': 'Painted Playgrounds: Aim 2: Assessments', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Painted Playgrounds: A Scalable Approach to Increasing Physical Activity and Motor Skills in Louisiana Preschool Aged Children. Aim 2: Assessments', 'orgStudyIdInfo': {'id': 'PBRC 2017-040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Participants attending the childcare centers randomized to this arm will receive the stencil activities after baseline assessments have been completed. We will follow-up with assessments after 6-8 weeks', 'interventionNames': ['Other: Playground Stencils']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Wait-List', 'description': 'Participants attending the childcare centers randomized to this arm will receive the stencil activities approximately 8 weeks after enrolling, after baseline and follow-up assessments have been completed.', 'interventionNames': ['Other: Playground Stencils']}], 'interventions': [{'name': 'Playground Stencils', 'type': 'OTHER', 'description': 'The stencils (hopscotch, agility trail, foursquare, bullseye, etc.) will be painted on the playgrounds at each childcare center. A toolkit and training video will be distributed to staff at each center to aid in instructing the children on how to perform the tasks.', 'armGroupLabels': ['Intervention', 'Wait-List']}]}, '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': 'Maura Kepper, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Cross Blue Shield', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amanda Staiano', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}