Sustainability Via Active Garden Education Wellness Implementation Strategies in Early Care and Education (SAGE WISE)

November 13, 2025 updated by: Rebecca Lee, Arizona State University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
871

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: (S1) E-support, (S2) in-person support, (S3) Learning collaborative
Schools will receive all three strategies: (S1) e-support implementation package which comprises the SAGE basic with the additional e-support implementation package that includs semi-weekly teacher text messages, a weekly check in phone call, and a teacher hotline. (S2) in person staff support and teacher training which requires SAGE curriculum activities to be completed in a single session to accommodate research staff schedules. (S3) virtual learning collaborative which will be developed in consultation with an advisory board with the goal of increasing the social network connectivity and community capacity about garden-based outdoor learning in preschoolers. ECE sites assigned to this condition will receive access to the original SAGE basic plus an online portal (such as a moderated Facebook private group) where they will be able to share information and interactions about garden learning. Monthly implementation "tips and tricks" video
Behavioral: SAGE Basic
SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.
Behavioral: SAGE e-support
Semi-weekly teacher text messages, a monthly newsletter and a teacher hotline
Behavioral: SAGE in-person support
Weekly in person support and training following the "see one, do one, teach one" model
Behavioral: Learning collaborative
Access to an online information-sharing portal, monthly newsletter, annual face-to-face half day conference
Experimental: (S1) E-support, (S2) in-person support
Schools will receive all two of the three strategies: (S1) e-support implementation package which comprises the SAGE basic with the additional e-support implementation package that includs semi-weekly teacher text messages, a weekly check in phone call, and a teacher hotline. (S2) in person staff support and teacher training which requires SAGE curriculum activities to be completed in a single session to accommodate research staff schedules.
Behavioral: SAGE Basic
SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.
Behavioral: SAGE e-support
Semi-weekly teacher text messages, a monthly newsletter and a teacher hotline
Behavioral: SAGE in-person support
Weekly in person support and training following the "see one, do one, teach one" model
Experimental: (S3) Learning collaborative, (S2) in-person support
Schools will receive two strategies: (S2) in person staff support and teacher training which requires SAGE curriculum activities to be completed in a single session to accommodate research staff schedules. (S3) virtual learning collaborative which will be developed in consultation with an advisory board with the goal of increasing the social network connectivity and community capacity about garden-based outdoor learning in preschoolers. ECE sites assigned to this condition will receive access to the original SAGE basic plus an online portal (such as a moderated Facebook private group) where they will be able to share information and interactions about garden learning. Monthly implementation "tips and tricks" video
Behavioral: SAGE Basic
SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.
Behavioral: SAGE in-person support
Weekly in person support and training following the "see one, do one, teach one" model
Behavioral: Learning collaborative
Access to an online information-sharing portal, monthly newsletter, annual face-to-face half day conference
Experimental: (S2) in-person support
Schools will receive all one strategy: (S2) in person staff support and teacher training which requires SAGE curriculum activities to be completed in a single session to accommodate research staff schedules.
Behavioral: SAGE Basic
SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.
Behavioral: SAGE in-person support
Weekly in person support and training following the "see one, do one, teach one" model
Experimental: Control
Schools will receive SAGE baseline curriculum access and study materials.
Behavioral: SAGE Basic
SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.
Experimental: (S1) E-support, (S3) Learning collaborative
Schools will receive all two strategies: (S1) e-support implementation package which comprises the SAGE basic with the additional e-support implementation package that includs semi-weekly teacher text messages, a weekly check in phone call, and a teacher hotline. (S3) virtual learning collaborative which will be developed in consultation with an advisory board with the goal of increasing the social network connectivity and community capacity about garden-based outdoor learning in preschoolers. ECE sites assigned to this condition will receive access to the original SAGE basic plus an online portal (such as a moderated Facebook private group) where they will be able to share information and interactions about garden learning. Monthly implementation "tips and tricks" video
Behavioral: SAGE Basic
SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.
Behavioral: SAGE e-support
Semi-weekly teacher text messages, a monthly newsletter and a teacher hotline
Behavioral: Learning collaborative
Access to an online information-sharing portal, monthly newsletter, annual face-to-face half day conference
Experimental: (S1) E-support
Schools will receive all one strategy: (S1) e-support implementation package which comprises the SAGE basic with the additional e-support implementation package that includes semi-weekly teacher text messages, a weekly check in phone call, and a teacher hotline.
Behavioral: SAGE Basic
SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.
Behavioral: SAGE e-support
Semi-weekly teacher text messages, a monthly newsletter and a teacher hotline
Experimental: (S3) Learning collaborative
Schools will receive one strategy: (S3) virtual learning collaborative which will be developed in consultation with an advisory board with the goal of increasing the social network connectivity and community capacity about garden-based outdoor learning in preschoolers. ECE sites assigned to this condition will receive access to the original SAGE basic plus an online portal (such as a moderated Facebook private group) where they will be able to share information and interactions about garden learning. Monthly implementation "tips and tricks" video
Behavioral: SAGE Basic
SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.
Behavioral: Learning collaborative
Access to an online information-sharing portal, monthly newsletter, annual face-to-face half day conference

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 mos post-test, 16 months follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 mos post-test, 16 months follow up
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
Baseline, 6 mos post-test, 16 mos follow up
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
Baseline, 6 mos post-test, 16 mos follow up
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.
Baseline, 6 mos post-test, 16 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arizona State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Penn State University
Texas A&M University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00022025
  • R01HD116828-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data collected as part of this project will be de-identified and made available on public websites that may be shared with investigators working under an institution with a Federal Wide Assurance (FWA). As there is no specific data sharing repository for the funding agency, the investigators will identify possible other repositories that may be appropriate to use. For whatever NIH-funded repository is advised to be used, the investigators acknowledge that this repository will have policies and procedures in place that will provide data access to qualified researchers, consistent with NIH data sharing policies and applicable laws and regulations. Data will be deposited to the repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award.

IPD Sharing Time Frame

Study protocol and statistical Analysis Plan will be available by January 2028 with no end date.

IPD Sharing Access Criteria

Data could be used for secondary study purposes such as finding additional relationships related to implementation and sustainability of garden based education in early care and education. Data will be openly available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings