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Completed

NCT Number: NCT03261492

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

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Key information

Age range

3 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

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

Other names: SAGE Garden Based Curriculum

Child Safety Attention Comparison

Behavioral

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).

Primary outcomes

  1. Change physical activity; sedentary time

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

    Assessed by ActiGraph accelerometers

  2. fruit and vegetable consumption

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

    24 hr diet recalls

Secondary outcomes

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

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

    Assessed by physical activity

  2. Impact on improved home fruit and vegetable availability

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

    Assessed by completing Home Food Inventory questionnaire

  3. Impact on parenting practices in fruits and vegetables

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

    Assessed by fruit and vegetable pactices questionnaire

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Partnering for PA in Early Childhood: Sustainability Via Active Garden Education

Acronym: SAGE

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Aug 25, 2017
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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