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Enrolling by Invitation

NCT Number: NCT07228819

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

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.

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Key information

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAGE Basic

Behavioral

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

SAGE e-support

Behavioral

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

SAGE in-person support

Behavioral

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

Learning Collaborative

Behavioral

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

Primary outcomes

  1. Implementation

    Time frame: 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 outcomes

  1. Locomotor skills

    Time frame: 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.

  2. Veggiemeter

    Time frame: Baseline, 6 mos post-test, 16 months follow up

    An objective assessment of fruit and vegetable intake through a direct measure of dietary carotenoids

  3. Eating in the absence of hunger

    Time frame: 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

  4. Moderate to vigorous physical activity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Penn State University
  • Texas A&M University

Registry information

Official study title

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

Acronym: SAGE WISE

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Nov 14, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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