Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-07 @ 12:46 AM
Study NCT ID:
NCT05048433
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2021-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-04', 'releaseDate': '2025-11-21'}, {'releaseDate': '2025-12-19'}], 'estimatedResultsFirstSubmitDate': '2025-11-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2021-09-08', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM)', 'timeFrame': 'Baseline', 'description': 'The Acceptability of Intervention Measure (AIM) is a 4-item measure that uses a 5-point Likert scale for each question. A sum score will be used, which can range from 4-20, with higher scores representing higher levels of acceptability.'}, {'measure': 'Acceptability of active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM)', 'timeFrame': '6 months follow up', 'description': 'The Acceptability of Intervention Measure (AIM) is a 4-item measure that uses a 5-point Likert scale for each question. A sum score will be used, which can range from 4-20, with higher scores representing higher levels of acceptability.'}, {'measure': 'Acceptability active learning among teachers as assessed by the Acceptability of Implementation Measure (AIM)', 'timeFrame': '12 months follow up', 'description': 'The Acceptability of Intervention Measure (AIM) is a 4-item measure that uses a 5-point Likert scale for each question. A sum score will be used, which can range from 4-20, with higher scores representing higher levels of acceptability.'}, {'measure': 'Implementation Fidelity as assessed by self-reported implementation logs to assess dose of delivery', 'timeFrame': '6 months', 'description': 'Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per week of active learning used.'}, {'measure': 'Implementation Fidelity as assessed by self-reported implementation logs to assess dose of delivery', 'timeFrame': '12 months', 'description': 'Implementation logs will be completed weekly throughout the study and dose of delivery is the number of minutes per week of active learning used.'}, {'measure': 'Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer', 'timeFrame': 'baseline'}, {'measure': 'Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer', 'timeFrame': '6 month follow up'}, {'measure': 'Student Physical Activity as indicated by number of minutes spent in moderate and vigorous physical activity as assessed by the Actigraph GT3X+ accelerometer', 'timeFrame': '12 month follow up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Implementation of Physical Activity Programs in Schools'], 'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '41310531', 'type': 'DERIVED', 'citation': 'Walker TJ, Craig DW, Pfledderer CD, Lee M, Onadeko K, Saving EE, Bartholomew JB, Fernandez ME. Feasibility and acceptability of an implementation strategy to enhance use of classroom-based physical activity approaches in elementary schools: a mixed methods study. BMC Public Health. 2025 Nov 27. doi: 10.1186/s12889-025-25333-0. Online ahead of print.'}, {'pmid': '35256018', 'type': 'DERIVED', 'citation': 'Walker TJ, Kohl HW 3rd, Bartholomew JB, Green C, Fernandez ME. Using Implementation Mapping to develop and test an implementation strategy for active learning to promote physical activity in children: a feasibility study using a hybrid type 2 design. Implement Sci Commun. 2022 Mar 7;3(1):26. doi: 10.1186/s43058-022-00271-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop an implementation strategy to improve the use and sustainment of active learning in elementary schools and to conduct a feasibility study to evaluate the impact of the developed implementation strategy on the implementation and effectiveness of active learning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lead teachers who teach kindergarten to fifth grade\n* children in kindergarten to fifth grade\n\nExclusion Criteria:\n\n* non English or Spanish speaking'}, 'identificationModule': {'nctId': 'NCT05048433', 'briefTitle': 'Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Developing and Testing an Implementation Strategy for Active Learning to Promote Physical Activity in Children', 'orgStudyIdInfo': {'id': 'HSC-SPH-20-0861'}, 'secondaryIdInfos': [{'id': 'K01HL151817', 'link': 'https://reporter.nih.gov/quickSearch/K01HL151817', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'implementation strategy for active learning to promote physical activity', 'interventionNames': ['Behavioral: implementation strategy for active learning to promote physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Implementation support', 'interventionNames': ['Behavioral: Usual Implementation support']}], 'interventions': [{'name': 'implementation strategy for active learning to promote physical activity', 'type': 'BEHAVIORAL', 'description': 'The experimental arm includes using a multifaceted implementation strategy to support the use of active learning approaches. The strategy will consist of a series of skills-based staff trainings, identifying program champions to help lead efforts within the school, establishing an audit and feedback system to monitor the use of active learning, and a reinforcement system to recognize staff who are successfully implementing.', 'armGroupLabels': ['implementation strategy for active learning to promote physical activity']}, {'name': 'Usual Implementation support', 'type': 'BEHAVIORAL', 'description': 'Usual support consists of the potential to access general resources from the district wellness department. These resources include access to funds to send staff to external trainings and general guidance for how to use active learning approaches.', 'armGroupLabels': ['Usual Implementation support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Timothy J Walker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Timothy J Walker', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-21', 'type': 'RELEASE'}, {'date': '2025-12-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Timothy J Walker, Assistant Professor, The University of Texas Health Science Center, Houston'}}}}