NCT03261492

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
712

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

3.5 years

First QC Date

April 13, 2017

Last Update Submit

April 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change physical activity; sedentary time

    Assessed by ActiGraph accelerometers

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

  • fruit and vegetable consumption

    24 hr diet recalls

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

Secondary Outcomes (3)

  • Impact on parenting practices in physical activity (PA)

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

  • Impact on improved home fruit and vegetable availability

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

  • Impact on parenting practices in fruits and vegetables

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

Study Arms (2)

Physical Activity

EXPERIMENTAL

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

Child Safety Attention Comparison

ACTIVE COMPARATOR

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

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

Also known as: SAGE Garden Based Curriculum
Physical Activity

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).

Child Safety Attention Comparison

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not participating in CACFP
  • No space for a garden
  • Less than 35 children aged 3-5 years old enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (3)

  • de Mello GT, Szeszulski J, O'Connor T, Lorenzo E, Hill JL, Lee RE. Effects of Sustainability via Active Garden Education on preschool-aged children's locomotor skills. Transl Behav Med. 2025 Jan 16;15(1):ibaf052. doi: 10.1093/tbm/ibaf052.

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rebecca E Lee, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: The investigators will identify, recruit, and randomize ECEC to the SAGE intervention or a child safety attention comparison. After 16 weeks, intervention and comparison will cross over, allowing us to continue to investigate longitudinal and carry over effects. One ECEC of each pair will be randomized to the SAGE intervention and the other to the child safety attention comparison. ECEC will cross over and receive the treatment that they did not receive to ensure that all ECEC receive both curriculums.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

August 25, 2017

Study Start

January 30, 2017

Primary Completion

July 30, 2020

Study Completion

December 31, 2021

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations