- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03261492
Sustainability Via Active Garden Education (SAGE)
April 21, 2025 updated by: Arizona State University
Partnering for PA in Early Childhood: Sustainability Via Active Garden Education
The goal of SAGE is to determine if a garden-based curriculum can increase physical activity and improve nutrition in young children at early care and education centers (ECEC) throughout Phoenix
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
SAGE will be delivered over a four month period using a cluster randomized controlled trial adapted crossover design, along with testing a sustainability action plan (SAP) at the organizational level.
In this study, the investigators will determine the efficacy of the SAGE intervention on health in 3-4 year-old children.
This study will pair match and randomize 20 ECEC from neighborhoods with high proportions of Hispanic or Latino residents.
ECEC will receive either the SAGE intervention or the safety attention comparison.
Then, ECEC will cross over and receive the treatment that they did not receive to ensure that all ECEC receive both curricula.
The investigators will determine improvement in accelerometry measured PA and sedentary behaviors, fruit and vegetable consumption and explore eating in the absence of hunger compared to those in a child safety attention comparison.
The investigators will explore secondary impacts on parenting practices that promote PA and fruit and vegetable consumption, home fruit and vegetable availability and improved household food security.
This study will explore the process of delivery of the SAGE intervention on dimensions of reach, adoption, and implementation.
This study will also develop, implement, and evaluate a SAP in the SAGE arm to determine replicability and institutionalization (sustainability) of the SAGE intervention and explore the relationship between of sustainability to child outcomes at follow-up.
The development and success of the community Partnership and SAGE Community Advisory Board will also be evaluated using indicators of participation, representativeness, and collaboration.
This study will rely on CBPR strategies and an established theoretical model to implement an engaging and translational multilevel intervention linking policy and practice.
This work will test strategies for implementing IOM guidelines at the ECE level and will guide future efforts aimed at scaling up efficacious interventions for broad dissemination in vulnerable populations to reduce health disparities.
Study Type
Interventional
Enrollment (Actual)
712
Phase
- 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
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Arizona
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Phoenix, Arizona, United States, 85004
- Arizona State University
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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
Ages Eligible for Study
3 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
ECEC Inclusion Criteria:
- Census tracts with >30% Hispanic-Latino population
- ECEC must be licensed and enroll at least 35 children aged 3-4 years old
- Space for garden install
Exclusion Criteria:
- Not participating in CACFP
- No space for a garden
- Less than 35 children aged 3-5 years old enrolled
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Physical Activity
SAGE curriculum is a garden-based PA and nutrition educational program and presently includes 12 lessons that can be delivered once or twice a week.
The SAGE garden-based curriculum includes active games and discussion as well as activities that include watering the ECEC garden.
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SAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.
Other Names:
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Active Comparator: Child Safety Attention Comparison
The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest.
The curriculum will include concepts and lessons for educating young children on fire, pedestrian, water, household, neighborhood and playground safety.
The curriculum includes handouts, coloring sheets, comic books, games, and songs that can be implemented with minimal training and preparation.
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The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change physical activity; sedentary time
Time Frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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Assessed by ActiGraph accelerometers
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Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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fruit and vegetable consumption
Time Frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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24 hr diet recalls
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Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact on parenting practices in physical activity (PA)
Time Frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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Assessed by physical activity
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Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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Impact on improved home fruit and vegetable availability
Time Frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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Assessed by completing Home Food Inventory questionnaire
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Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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Impact on parenting practices in fruits and vegetables
Time Frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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Assessed by fruit and vegetable pactices questionnaire
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Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rebecca E Lee, PhD, Arizona State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Szeszulski J, Lorenzo E, Todd M, O'Connor TM, Hill J, Shaibi GQ, Vega-Lopez S, Buman MP, Hooker SP, Lee RE. Early Care and Education Center Environmental Factors Associated with Product- and Process-Based Locomotor Outcomes in Preschool-Age Children. Int J Environ Res Public Health. 2022 Feb 15;19(4):2208. doi: 10.3390/ijerph19042208.
- Szeszulski J, Lorenzo E, O'Connor T, Hill JL, Shaibi GQ, Buman MP, Vega-Lopez S, Hooker SP, Lee RE. Exploring Correlates of Preschool-Aged Children's Locomotor Skills: Individual and Parent Demographics and Home Environment. Percept Mot Skills. 2021 Apr;128(2):649-671. doi: 10.1177/0031512520980938. Epub 2020 Dec 20.
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)
January 30, 2017
Primary Completion (Actual)
July 30, 2020
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
April 13, 2017
First Submitted That Met QC Criteria
August 22, 2017
First Posted (Actual)
August 25, 2017
Study Record Updates
Last Update Posted (Actual)
April 24, 2025
Last Update Submitted That Met QC Criteria
April 21, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 5U01MD010667 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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