Sustainability Via Active Garden Education

Physical Activity Clinical Trial

— SAGE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03261492
• Other study ID #: 5U01MD010667
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2020
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1275
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Physical Activity
SAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.
• 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).

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change physical activity; sedentary time	Assessed by ActiGraph accelerometers	Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Primary	fruit and vegetable consumption	24 hr diet recalls	Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Secondary	Impact on parenting practices in physical activity (PA)	Assessed by physical activity	Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Secondary	Impact on improved home fruit and vegetable availability	Assessed by completing Home Food Inventory questionnaire	Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months
Secondary	Impact on parenting practices in fruits and vegetables	Assessed by fruit and vegetable pactices questionnaire	Four assessment periods: baseline, 4 months, 8 months weeks, and 12 months