Clinical Trials Directory

Trials / Completed

CompletedNCT03261492

Sustainability Via Active Garden Education

Partnering for PA in Early Childhood: Sustainability Via Active Garden Education

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
712 (actual)
Sponsor
Arizona State University · Academic / Other
Sex
All
Age
3 Years – 65 Years
Healthy volunteers
Accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPhysical ActivitySAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.
BEHAVIORALChild Safety Attention ComparisonThe 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).

Timeline

Start date
2017-01-30
Primary completion
2020-07-30
Completion
2021-12-31
First posted
2017-08-25
Last updated
2025-04-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03261492. Inclusion in this directory is not an endorsement.