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

NCT ID: NCT07228819

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

871 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-02

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

SAGE Basic

Intervention Type BEHAVIORAL

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

SAGE e-support

Intervention Type BEHAVIORAL

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

SAGE in-person support

Intervention Type BEHAVIORAL

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

Learning collaborative

Intervention Type BEHAVIORAL

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

(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.

Group Type EXPERIMENTAL

SAGE Basic

Intervention Type BEHAVIORAL

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

SAGE e-support

Intervention Type BEHAVIORAL

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

SAGE in-person support

Intervention Type BEHAVIORAL

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

(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

Group Type EXPERIMENTAL

SAGE Basic

Intervention Type BEHAVIORAL

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

SAGE in-person support

Intervention Type BEHAVIORAL

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

Learning collaborative

Intervention Type BEHAVIORAL

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

(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.

Group Type EXPERIMENTAL

SAGE Basic

Intervention Type BEHAVIORAL

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

SAGE in-person support

Intervention Type BEHAVIORAL

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

Control

Schools will receive SAGE baseline curriculum access and study materials.

Group Type EXPERIMENTAL

SAGE Basic

Intervention Type BEHAVIORAL

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

(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

Group Type EXPERIMENTAL

SAGE Basic

Intervention Type BEHAVIORAL

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

SAGE e-support

Intervention Type BEHAVIORAL

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

Learning collaborative

Intervention Type BEHAVIORAL

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

(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.

Group Type EXPERIMENTAL

SAGE Basic

Intervention Type BEHAVIORAL

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

SAGE e-support

Intervention Type BEHAVIORAL

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

(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

Group Type EXPERIMENTAL

SAGE Basic

Intervention Type BEHAVIORAL

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

Learning collaborative

Intervention Type BEHAVIORAL

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

Interventions

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SAGE Basic

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

Intervention Type BEHAVIORAL

SAGE e-support

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

Intervention Type BEHAVIORAL

SAGE in-person support

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

Intervention Type BEHAVIORAL

Learning collaborative

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Penn State University

OTHER

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Arizona State University

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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R01HD116828-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00022025

Identifier Type: -

Identifier Source: org_study_id

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