Arizona State University
Phoenix, Arizona, 85004, United States
NCT Number: NCT03261492
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
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Notify Me3 year–65 year
All sexes
Interventional
Not applicable
Phoenix, Arizona, 85004, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
ECEC Inclusion Criteria:
Exclusion criteria
SAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.
Other names: SAGE Garden Based Curriculum
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).
Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Assessed by ActiGraph accelerometers
Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
24 hr diet recalls
Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Assessed by physical activity
Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Assessed by completing Home Food Inventory questionnaire
Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Assessed by fruit and vegetable pactices questionnaire
Arizona State University
Other
Partnering for PA in Early Childhood: Sustainability Via Active Garden Education
Acronym: SAGE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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