ClinicalTrials.gg
CompletedNCT03261492SAGEUpdated Apr 24, 2025

Sustainability Via Active Garden Education

An interventional study of Physical Activity and Child Safety Attention Comparison in Physical Activity, sponsored by Arizona State University. Completed at 1 site in United States. Open to participants aged 3 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.

Sponsored by Arizona State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
712
Allocation
Randomized
Ages
3 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 27 studies in Motor Activity by Arizona State University — 5 open to participants now, 6 under way, none of them phase 3. Motor Activity · Arizona State University.

Enrollment
5th of 26
712 · median 141
Started
2017
with 3 others
No phase
24 of 27
4 open now
Registered
11th of 27
by date

Among the 27 studies in Motor Activity by Arizona State University, this one is the 5th largest by enrollment of the 26 interventional ones that give a count, is one of 4 that started in 2017, is one of 24 with no phase, and was the 11th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

5 of the 27 studies in Motor Activity by Arizona State University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 3 Years to 65 Years · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 27 studies in Motor Activity by Arizona State University, or all of them as a file.
02

Study summary

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

Read the 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.

03

Conditions studied

  • Physical Activity

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04

Who can participate

Ages eligible
3 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
712 participants (actual)

Study arms

  • 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.

    Behavioral: Physical Activity

  • 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.

    Behavioral: Child Safety Attention Comparison

Interventions

  • BehavioralPhysical Activity

    SAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.

    Also known as: SAGE Garden Based Curriculum

  • BehavioralChild 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).

06

What researchers measure

Primary outcomes

  1. Change physical activity; sedentary time

    Assessed by ActiGraph accelerometers

    Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months

  2. fruit and vegetable consumption

    24 hr diet recalls

    Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months

Secondary outcomes

  1. Impact on parenting practices in physical activity (PA)

    Assessed by physical activity

    Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months

  2. Impact on improved home fruit and vegetable availability

    Assessed by completing Home Food Inventory questionnaire

    Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months

  3. Impact on parenting practices in fruits and vegetables

    Assessed by fruit and vegetable pactices questionnaire

    Time frame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months

07

Study locations

1 site
  • Arizona State University
    Phoenix, Arizona 85004, United States
08

References and documents

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. PubMed 35206392 ↗
  • 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. PubMed 33342342 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Jul 2020, 42 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 42 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2017
First posted
Aug 25, 2017
StartActual
Jan 30, 2017
Primary completionActual
Jul 30, 2020
CompletionActual
Dec 31, 2021
Last update
Apr 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03261492
Responsible party
Sponsor
First posted
Aug 25, 2017
Start date
Jan 30, 2017
Primary completion
Jul 30, 2020
Completion
Dec 31, 2021
Last update
Apr 24, 2025

Study contacts

Rebecca E Lee, PhD
principal investigator · Arizona State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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