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临床试验/NCT03261492
NCT03261492已完成不适用

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

Arizona State University2 个研究点 分布在 1 个国家目标入组 712 人开始时间: 2017年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
712
试验地点
2
主要终点
fruit and vegetable consumption

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

fruit and vegetable consumption

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

24 hr diet recalls

Change physical activity; sedentary time

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

Assessed by ActiGraph accelerometers

次要结局

  • 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 physical activity (PA)(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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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