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Implementation ScienceSAGE WISENCT07228819

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

A study testing SAGE Basic, SAGE e-support and SAGE in-person support in people with Implementation Science and Diet, Food, and Nutrition, run by Arizona State University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 years and olderHealthy volunteers can take part
What is being tested?
SAGE Basic, SAGE e-support and SAGE in-person support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
871 participants
Where
1 siteUnited States
Study dates
2 Oct 2025to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Allergy or condition which prohibits participation in garden-based curricula

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Arizona State University

    Phoenix, Arizona, 85004

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
SAGE Basic, SAGE e-support, SAGE in-person support, Learning collaborative
Keywords
Child, Preschool, Nutrition, Exercise, Health, Policy, School, Garden
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAGE BasicBehavioural

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

  • SAGE e-supportBehavioural

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

  • SAGE in-person supportBehavioural

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

  • Learning collaborativeBehavioural

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

Study groups in NCT07228819
Study groupRoleWhat they receive
Experimental: (S1) E-support, (S2) in-person support, (S3) Learning collaborativeExperimentalSchools 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
Receives: Behavioral: SAGE Basic; Behavioral: SAGE e-support; Behavioral: SAGE in-person support; Behavioral: Learning collaborative
(S1) E-support, (S2) in-person supportExperimentalSchools 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.
Receives: Behavioral: SAGE Basic; Behavioral: SAGE e-support; Behavioral: SAGE in-person support
(S3) Learning collaborative, (S2) in-person supportExperimentalSchools 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
Receives: Behavioral: SAGE Basic; Behavioral: SAGE in-person support; Behavioral: Learning collaborative
(S2) in-person supportExperimentalSchools 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.
Receives: Behavioral: SAGE Basic; Behavioral: SAGE in-person support
ControlExperimentalSchools will receive SAGE baseline curriculum access and study materials.
Receives: Behavioral: SAGE Basic
(S1) E-support, (S3) Learning collaborativeExperimentalSchools 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
Receives: Behavioral: SAGE Basic; Behavioral: SAGE e-support; Behavioral: Learning collaborative
(S1) E-supportExperimentalSchools 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.
Receives: Behavioral: SAGE Basic; Behavioral: SAGE e-support
(S3) Learning collaborativeExperimentalSchools 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
Receives: Behavioral: SAGE Basic; Behavioral: Learning collaborative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implementation

    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.

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

Secondary outcomes (4)
  1. Locomotor skills

    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.

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

  2. Veggiemeter

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

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

  3. Eating in the absence of hunger

    Children are tested on consumption of sweet and salty snacks immediately following a meal to determine whether they eat in the absence of hunger

    Measured: Baseline, 6 mos post-test, 16 mos follow up

  4. Moderate to vigorous physical activity

    Children wear a small accelerometer device to measure MVPA for a six hour period on consecutive days during the ECE day

    Measured: Baseline, 6 mos post-test, 16 mos follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2025
  2. Study start2 Oct 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
871 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07228819
Sponsor's protocol ID
STUDY00022025
Other IDs
R01HD116828-01
Acronym
SAGE WISE
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing SAGE Basic, SAGE e-support and SAGE in-person support in people with Implementation Science and Diet, Food, and Nutrition, run by Arizona State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implementation (time frame: Baseline, 6 mos post-test, 16 months follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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