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Sustainability Via Active Garden Education Wellness Implementation Strategies in Early Care and Education

Sustainability Via Active Garden Education (SAGE): Scaling up Evidence-based, Policy-guided Physical Activity and Nutrition Education for Preschoolers

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07228819
Acronym
SAGE WISE
Enrollment
871
Registered
2025-11-14
Start date
2025-10-02
Completion date
2029-12-31
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implementation Science, Diet, Food, and Nutrition, Child Care, Motor Behavior

Keywords

Child, Preschool, Nutrition, Exercise, Health, Policy, School, Garden

Brief summary

This project compares four SAGE implementation strategies to evaluate effectiveness in implementation, sustainability, cost, and child health outcomes. Using the CFIR and MOST frameworks, the investigators will analyze key components to identify the most efficient and scalable strategies. Data will come from ECE site audits, surveys, social network analysis, and child health assessments. Findings will inform sustainable, cost-effective approaches to improve early childhood nutrition and physical activity.

Detailed description

The overall objective of this project is to compare how four different SAGE implementation strategies impact measures of implementation (primary), sustainability (secondary), cost and child health outcomes (secondary). Strategies the investigators will compare include (1) SAGE (garden + online curriculum + materials box) vs. SAGE plus e-support implementation package (text messages + newsletters + hotline), (2) SAGE with no in person support and training vs. SAGE with in person support and training, and (3) SAGE usual activities vs. SAGE with a ECE virtual learning collaborative to share SAGE implementation experiences and strategies with other ECE sites and community partners. The investigators will (Aim 1) apply the Consolidated Framework for Implementation Research (CFIR) to identify inner and outer setting characteristics that hinder or facilitate SAGE implementation to tailor support strategies for local context; (Aim 2) use the Multiphase Optimization Strategy (MOST) framework to analyze SAGE implementation strategy components to determine the most efficient and effective combination of strategies across contexts; and (Aim 3) investigate the potential for sustainability, costs and cost effectiveness outcomes that may influence implementation strategies and their effect on locomotor skills and nutrition effectiveness outcomes. In Aim 1 (MOST screening), the investigators will measure ECE site and teacher characteristics via an in person visual assessment and a teacher and director survey (inner setting). The investigators will also complete a social network analysis of ECE personnel. With this information the investigators will use an implementation mapping process to collaboratively develop and finalize implementation strategies. In Aim 2 (MOST refine), 32 existing SAGE ECE sites will be pair matched by degree of individual implementation and site characteristics (size, enrollment) assessed in aim 1, and assigned to one of eight implementation strategy combinations to a full factorial model. Sites will be assessed at the beginning and ending of the academic year with site audits, parent and teacher surveys, and non-invasive child fitness, physical activity, veggiemeter and eating in the absence of hunger measures. For Aim 3, (MOST refine) the potential for sustainability, costs and cost effectiveness ratio for each of the strategies will be calculated from a payer and societal perspective to determine which implementation strategy or combination of strategies may be most scalable.

Interventions

BEHAVIORALSAGE Basic

SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.

BEHAVIORALSAGE e-support

Semi-weekly teacher text messages, a monthly newsletter and a teacher hotline

BEHAVIORALSAGE in-person support

Weekly in person support and training following the see one, do one, teach one model

Access to an online information-sharing portal, monthly newsletter, annual face-to-face half day conference

Sponsors

Penn State University
CollaboratorOTHER
Texas A&M University
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Inclusionary criteria: ECE personnel, child, or parent of enrolled eligible ECE site Provided consent and/or assent

Exclusion criteria

Allergy or condition which prohibits participation in garden-based curricula

Design outcomes

Primary

MeasureTime frameDescription
ImplementationBaseline, 6 mos post-test, 16 months follow upProportion of teachers who rate SAGE as acceptable, appropriate, and feasible to implement. Proportion of teachers completing at least 70% of curriculum activities as measured by weekly fidelity checklists.

Secondary

MeasureTime frameDescription
Locomotor skillsBaseline, 6 mos post-test, 16 months follow upThe Children's Activity and Movement in Preschool Study Motor Skills Protocol (CMSP) measures six developmentally appropriate skills (run, broad jump, slide, gallop, leap, and hop). The locomotor subscale ranges from 0 to 64 skill components, with a higher score indicating better locomotor skills.
VeggiemeterBaseline, 6 mos post-test, 16 months follow upAn objective assessment of fruit and vegetable intake through a direct measure of dietary carotenoids
Eating in the absence of hungerBaseline, 6 mos post-test, 16 mos follow upChildren are tested on consumption of sweet and salty snacks immediately following a meal to determine whether they eat in the absence of hunger
Moderate to vigorous physical activityBaseline, 6 mos post-test, 16 mos follow upChildren wear a small accelerometer device to measure MVPA for a six hour period on consecutive days during the ECE day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026