Clinical trial NCT03261492: Sustainability Via Active Garden Education
Official title: Partnering for PA in Early Childhood: Sustainability Via Active Garden Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-08-25
Enrollment: 712
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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

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.

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

Primary outcomes:
measure: Change physical activity; sedentary time
timeFrame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
measure: fruit and vegetable consumption
timeFrame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Secondary outcomes:
measure: Impact on parenting practices in physical activity (PA)
timeFrame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
measure: Impact on improved home fruit and vegetable availability
timeFrame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
measure: Impact on parenting practices in fruits and vegetables
timeFrame: Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Rebecca E Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.