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Enrolling by invitation NCT07228819

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

No phase Interventional Implementation Science Diet, Food, and Nutrition Child Care Motor Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SAGE Basic, SAGE e-support, SAGE in-person support, Learning collaborative.
Who it may be relevant to
Registry conditions: Implementation Science, Diet, Food, and Nutrition, Child Care, Motor Behavior. Basic parameters: from 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Implementation [Time frame: Baseline, 6 mos post-test, 16 months follow up]
Secondary outcome measures (4)
  • Locomotor skills [Time frame: Baseline, 6 mos post-test, 16 months follow up]
  • Veggiemeter [Time frame: 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]
  • Moderate to vigorous physical activity [Time frame: Baseline, 6 mos post-test, 16 mos follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Arizona State University — Phoenix

Identifiers

NCT: NCT07228819 · STUDY00022025 · R01HD116828-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗