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Title: Design and methodology of a cluster-randomized trial in early care and education centers to meet physical activity guidelines: Sustainability via Active Garden Education (SAGE)

Author
item LEE, REBECCA - Arizona State University
item LORENZO, ELIZABETH - Arizona State University
item SZESZULSKI, JACOB - Arizona State University
item ARRIOLA, ANEL - Arizona State University
item BRUENING, MEG - Arizona State University
item ESTABROOKS, PAUL - University Of Nebraska
item HILL, JENNIE - University Of Nebraska
item MARSIGLIA, FLAVIO - Arizona State University
item O'CONNOR, TERESIA - Children'S Nutrition Research Center (CNRC)
item POLLINS, KIM - Booker T Washington Early Childhood Learning Center
item SHAIBI, GABRIEL - Arizona State University
item SOLTERO, ERICA - Arizona State University
item TODD, MICHAEL - Arizona State University

Submitted to: Contemporary Clinical Trials
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 12/10/2018
Publication Date: 2/1/2019
Citation: Lee, R.E., Lorenzo, E., Szeszulski, J., Arriola, A., Bruening, M., Estabrooks, P.A., Hill, J., Marsiglia, F.F., O'Connor, T., Pollins, K.S., Shaibi, G.Q., Soltero, E., Todd, M. 2019. Design and methodology of a cluster-randomized trial in early care and education centers to meet physical activity guidelines: Sustainability via Active Garden Education (SAGE). Contemporary Clinical Trials. 77:8-18. https://doi.org/10.1016/j.cct.2018.12.003.
DOI: https://doi.org/10.1016/j.cct.2018.12.003

Interpretive Summary: Early care and education centers (ECEC) have policies in place to promote physical activity, and fruit and vegetable intake guidelines for young children. However, curricula are needed that meet the current guidelines and have evidence for improving children's physical activity and fruit and vegetable intake. This manuscript describes the design and methodology to evaluate Sustainability via Active Garden Education (SAGE), a ECEC curriculum that meets health policy guidelines and educational accreditation standards. A cluster randomized controlled trial with a cross-over design for 20 ECEC is being used to evaluate SAGE with a community-based participatory research approach. ECEC are being selected with high enrollment of Hispanic children. The SAGE curriculum uses the plant life-cycle as a metaphor for human development. Children learn about the plant life cycle, gardening, simple food preparation, and sampling fruit and vegetables through tending to a school garden installed at the school, active learning songs, games, science experiments, mindful eating exercises, and interactive discussions. Parents receive newsletters and texts to support the children at home. The evaluation includes physical activity, height, and weight on the children and observations during meal and snack times to document dietary habits. Parents also report on the child's dietary habits outside of the ECEC, their parenting practices, home physical activity resources, and home fruit and vegetable availability. Resources and training are put in place to support the teacher and ECEC to sustain SAGE after the study ends. If successful, SAGE may inform widespread dissemination and implementation of the curricula to reduce health disparities and improve health equity.

Technical Abstract: Strategies are needed to help early care and education centers (ECEC) comply with policies to meet daily physical activity and fruit and vegetable guidelines for young children. This manuscript describes the design and methodology of Sustainability via Active Garden Education (SAGE), a 12-session cluster-randomized controlled crossover design trial using community-based participatory research (CBPR) to test a garden-based ECEC physical activity and fruit and vegetables promotion intervention for young children aged 3-5 years in 20 sites. The SAGE curriculum uses the plant lifecycle as a metaphor for human development. Children learn how to plant, water, weed, harvest, and do simple food preparation involving washing, cleaning, and sampling fruit and vegetables along with active learning songs, games, science experiments, mindful eating exercises, and interactive discussions to reinforce various healthy lifestyle topics. Parents will receive newsletters and text messages linked to the curriculum, describing local resources and events, and to remind them about activities and assessments. Children will be measured on physical activity, height, and weight and observed during meal and snack times to document dietary habits. Parents will complete measures about dietary habits outside of the ECEC, parenting practices, home physical activity resources, and home fruit and vegetable availability. SAGE fills an important void in the policy literature by employing a participatory strategy to produce a carefully crafted and engaging curriculum with the goal of meeting health policy guidelines and educational accreditation standards. If successful, SAGE may inform and inspire widespread dissemination and implementation to reduce health disparities and improve health equity.