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

Not Applicable

• Conditions: Implementation Science; Diet, Food, and Nutrition; Child Care; Motor Behavior

• Registration Number: NCT07228819
• Lead Sponsor: Arizona State University

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.

Study Timeline

• Study Start: 2025-10-02
• Status Verified: 2025-11
• Study First Submitted: 2025-11-13
• Study First Submitted QC: 2025-11-13
• Last Update Submitted: 2025-11-13
• Study First Posted: 2025-11-14
• Last Update Posted: 2025-11-17
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 871

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Implementation	Baseline, 6 mos post-test, 16 months follow up	Proportion 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 Outcome Measures

Name	Time	Method
Locomotor skills	Baseline, 6 mos post-test, 16 months follow up	The 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.
Veggiemeter	Baseline, 6 mos post-test, 16 months follow up	An objective assessment of fruit and vegetable intake through a direct measure of dietary carotenoids
Eating in the absence of hunger	Baseline, 6 mos post-test, 16 mos follow up	Children 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 activity	Baseline, 6 mos post-test, 16 mos follow up	Children wear a small accelerometer device to measure MVPA for a six hour period on consecutive days during the ECE day

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States