Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-04-16 @ 2:31 AM
Study NCT ID:
NCT03261492
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustainability Via Active Garden Education
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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The investigators will identify, recruit, and randomize ECEC to the SAGE intervention or a child safety attention comparison. After 16 weeks, intervention and comparison will cross over, allowing us to continue to investigate longitudinal and carry over effects. One ECEC of each pair will be randomized to the SAGE intervention and the other to the child safety attention comparison. ECEC will cross over and receive the treatment that they did not receive to ensure that all ECEC receive both curriculums.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 712}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2017-08-22', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change physical activity; sedentary time', 'timeFrame': 'Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months', 'description': 'Assessed by ActiGraph accelerometers'}, {'measure': 'fruit and vegetable consumption', 'timeFrame': 'Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months', 'description': '24 hr diet recalls'}], 'secondaryOutcomes': [{'measure': 'Impact on parenting practices in physical activity (PA)', 'timeFrame': 'Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months', 'description': 'Assessed by physical activity'}, {'measure': 'Impact on improved home fruit and vegetable availability', 'timeFrame': 'Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months', 'description': 'Assessed by completing Home Food Inventory questionnaire'}, {'measure': 'Impact on parenting practices in fruits and vegetables', 'timeFrame': 'Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months', 'description': 'Assessed by fruit and vegetable pactices questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity']}, 'referencesModule': {'references': [{'pmid': '41047236', 'type': 'DERIVED', 'citation': "de Mello GT, Szeszulski J, O'Connor T, Lorenzo E, Hill JL, Lee RE. Effects of Sustainability via Active Garden Education on preschool-aged children's locomotor skills. Transl Behav Med. 2025 Jan 16;15(1):ibaf052. doi: 10.1093/tbm/ibaf052."}, {'pmid': '35206392', 'type': 'DERIVED', 'citation': "Szeszulski J, Lorenzo E, Todd M, O'Connor TM, Hill J, Shaibi GQ, Vega-Lopez S, Buman MP, Hooker SP, Lee RE. Early Care and Education Center Environmental Factors Associated with Product- and Process-Based Locomotor Outcomes in Preschool-Age Children. Int J Environ Res Public Health. 2022 Feb 15;19(4):2208. doi: 10.3390/ijerph19042208."}, {'pmid': '33342342', 'type': 'DERIVED', 'citation': "Szeszulski J, Lorenzo E, O'Connor T, Hill JL, Shaibi GQ, Buman MP, Vega-Lopez S, Hooker SP, Lee RE. Exploring Correlates of Preschool-Aged Children's Locomotor Skills: Individual and Parent Demographics and Home Environment. Percept Mot Skills. 2021 Apr;128(2):649-671. doi: 10.1177/0031512520980938. Epub 2020 Dec 20."}]}, 'descriptionModule': {'briefSummary': 'The goal of SAGE is to determine if a garden-based curriculum can increase physical activity and improve nutrition in young children at early care and education centers (ECEC) throughout Phoenix', 'detailedDescription': 'SAGE will be delivered over a four month period using a cluster randomized controlled trial adapted crossover design, along with testing a sustainability action plan (SAP) at the organizational level. In this study, the investigators will determine the efficacy of the SAGE intervention on health in 3-4 year-old children. This study will pair match and randomize 20 ECEC from neighborhoods with high proportions of Hispanic or Latino residents. ECEC will receive either the SAGE intervention or the safety attention comparison. Then, ECEC will cross over and receive the treatment that they did not receive to ensure that all ECEC receive both curricula. The investigators will determine improvement in accelerometry measured PA and sedentary behaviors, fruit and vegetable consumption and explore eating in the absence of hunger compared to those in a child safety attention comparison. The investigators will explore secondary impacts on parenting practices that promote PA and fruit and vegetable consumption, home fruit and vegetable availability and improved household food security. This study will explore the process of delivery of the SAGE intervention on dimensions of reach, adoption, and implementation. This study will also develop, implement, and evaluate a SAP in the SAGE arm to determine replicability and institutionalization (sustainability) of the SAGE intervention and explore the relationship between of sustainability to child outcomes at follow-up. The development and success of the community Partnership and SAGE Community Advisory Board will also be evaluated using indicators of participation, representativeness, and collaboration. This study will rely on CBPR strategies and an established theoretical model to implement an engaging and translational multilevel intervention linking policy and practice. This work will test strategies for implementing IOM guidelines at the ECE level and will guide future efforts aimed at scaling up efficacious interventions for broad dissemination in vulnerable populations to reduce health disparities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'ECEC Inclusion Criteria:\n\n* Census tracts with \\>30% Hispanic-Latino population\n* ECEC must be licensed and enroll at least 35 children aged 3-4 years old\n* Space for garden install\n\nExclusion Criteria:\n\n* Not participating in CACFP\n* No space for a garden\n* Less than 35 children aged 3-5 years old enrolled'}, 'identificationModule': {'nctId': 'NCT03261492', 'acronym': 'SAGE', 'briefTitle': 'Sustainability Via Active Garden Education', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Partnering for PA in Early Childhood: Sustainability Via Active Garden Education', 'orgStudyIdInfo': {'id': '5U01MD010667', 'link': 'https://reporter.nih.gov/quickSearch/5U01MD010667', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Activity', 'description': 'SAGE curriculum is a garden-based PA and nutrition educational program and presently includes 12 lessons that can be delivered once or twice a week. The SAGE garden-based curriculum includes active games and discussion as well as activities that include watering the ECEC garden.', 'interventionNames': ['Behavioral: Physical Activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Child Safety Attention Comparison', 'description': 'The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest. The curriculum will include concepts and lessons for educating young children on fire, pedestrian, water, household, neighborhood and playground safety. The curriculum includes handouts, coloring sheets, comic books, games, and songs that can be implemented with minimal training and preparation.', 'interventionNames': ['Behavioral: Child Safety Attention Comparison']}], 'interventions': [{'name': 'Physical Activity', 'type': 'BEHAVIORAL', 'otherNames': ['SAGE Garden Based Curriculum'], 'description': 'SAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.', 'armGroupLabels': ['Physical Activity']}, {'name': 'Child Safety Attention Comparison', 'type': 'BEHAVIORAL', 'description': 'The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest).', 'armGroupLabels': ['Child Safety Attention Comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Rebecca E Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}