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临床试验/NCT04045288
NCT04045288已完成不适用

SWITCH Implementation Effectiveness Trial

Iowa State University2 个研究点 分布在 1 个国家目标入组 1,984 人开始时间: 2017年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,984
试验地点
2
主要终点
Moderate to Vigorous Physical Activity (minutes / day); Youth Activity Profile (YAP) assessment

研究概览

简要总结

The SWITCH (School Wellness Integration Targeting Child Health) project is a multi-component intervention designed to support school wellness programming and contribute to youth obesity prevention. Consistent with social-ecological models, SWITCH is designed to reach multiple settings within schools while also facilitating engagement with families and community partners. The program focuses on three distinct behaviors known to impact obesity (i.e., physical activity (PA), sedentary behavior (SB) and fruit and vegetable consumption (FV)) in a creative way by challenging children to "switch what they do, view and chew".

详细描述

Schools provide an ideal setting for coordinated youth obesity prevention but it has proven difficult to widely disseminate evidence-based programs in a cost-effective way. Multi-component programs that target multiple behaviors and reach multiple settings have been widely recommended in both scientific literature and in public health guidelines documents, but there are few examples of integrated social-ecological approaches that offer promise for broad dissemination.

SWITCH initially began as a controlled childhood obesity intervention trial. A limitation of the original SWITCH program is that the print-based materials made it cost-prohibitive to promote broader dissemination, or to engage other schools. Therefore, the focus of subsequent work focused on developing and testing implementation strategies that would enable SWITCH to be more widely disseminated. In a controlled effectiveness study, we demonstrated that a web-based version had similar utility and outcomes as the print-based program, but effects were directly related to the degree of engagement within the school. Through a USDA-funded project, we developed a novel training method designed to facilitate greater adoption and more effective implementation of SWITCH in schools. The focus in this revised SWITCH model was on helping schools to independently manage the implementation of the evidence-based SWITCH program as part of overall school wellness programming. Thus, we have gradually evolved SWITCH from a school-based intervention conducted through schools to a school wellness training method provided for schools. Schools received

Before moving to broader dissemination efforts it was important to determine the dose of training and support needed to assist schools with implementation. Therefore, the focus of this study was on comparing two different implementation approaches. An enhanced capacity building model that included personalized webinars with school leaders (Enhanced) was compared to a streamlined model based on email communication (Standard). Thus, a key goal is to determine the additive benefit of the enhanced school support relative to the standard implementation. Past work has demonstrated that there is considerable variability in the capacity of schools to take on and lead school wellness programming. Therefore, the analyses also directly examined the moderating influence of school capacity on implementation as well as the impact of implementation on outcomes.

研究设计

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

入排标准

年龄范围
9 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All students in schools who completed agreement forms and who formed a three-person core team that attended the conference

排除标准

  • All students in schools that did not complete agreement forms, attend the school wellness conference, or form a core team

研究组 & 干预措施

Standard Implementation

Active Comparator

All schools in SWITCH receive training through webinars and an in-person conference to learn about the defining elements and school wellness programming in general. Consistent with the standard implementation, schools were added to the online content management system (CMS) and were given access to an online community of practice (CoP) to interact with other schools / teachers in the study. Schools were provided with resources and program materials (i.e. educational modules, trinkets, posters, etc.) but were given autonomy with regard to how they were used within their school. Weekly updates through the online CMS, the CoP, and via direct email correspondence provided information about the weekly corresponding weekly themes, implementation tips, recommended module activities to incorporate, upcoming evaluation needs, important SWITCH dates, and other program reminders.

干预措施: Standard Implementation (Behavioral)

Enhanced Implementation

Experimental

The 'Enhanced' implementation strategy provided schools with the same training, access and resources as the standard SWITCH implementation along with more personalized, web-based training based on motivational interviewing (MI) techniques and feedback throughout the implementation process. The supplemental support was provided through participation in two online 'checkpoint sessions' that helped schools self-assess their use of the recommended quality elements and setting-specific best practices. The sessions used principles of motivational interviewing (MI) to promote autonomy and motivation for school change through the process. Schools were also provided with information about how to capitalize on support from local 4H program leaders in their county.

干预措施: Enhanced Implementation (Behavioral)

Enhanced Implementation

Experimental

The 'Enhanced' implementation strategy provided schools with the same training, access and resources as the standard SWITCH implementation along with more personalized, web-based training based on motivational interviewing (MI) techniques and feedback throughout the implementation process. The supplemental support was provided through participation in two online 'checkpoint sessions' that helped schools self-assess their use of the recommended quality elements and setting-specific best practices. The sessions used principles of motivational interviewing (MI) to promote autonomy and motivation for school change through the process. Schools were also provided with information about how to capitalize on support from local 4H program leaders in their county.

干预措施: Standard Implementation (Behavioral)

结局指标

主要结局

Moderate to Vigorous Physical Activity (minutes / day); Youth Activity Profile (YAP) assessment

时间窗: Change from baseline to 12 weeks

The estimate of daily MVPA is obtained from the calibrated , online self-report tool (Youth Activity Profile) built into the web-based content management system. Students complete 5 items capturing school activity and 5 items capturing home activity. The data are then processed using validated algorithms to create estimates of time spent in physical activity behavior.

Sedentary Behavior (hours / day); Youth Activity Profile (YAP) assessment

时间窗: Change from baseline to 12 weeks

The estimate of time spent in sedentary behavior (outside of school) is obtained from a calibrated, online self-report tool (Youth Activity Profile) built into the web-based content management system. Students complete 5 items capturing general amounts of sedentary behavior. The data are then processed using validated algorithms to create estimates of time spent in sedentary behavior.

School Capacity for Wellness Programming; School Wellness Readiness Assessment

时间窗: Change from baseline to 12 weeks

The assessment of school capacity for wellness programming is obtained at both pre and post time points using the School Wellness Readiness Assessment (SWRA) based on work by Holt et al. (2009). The instrument developed specifically for SWITCH captures Structural barriers (Individual and Organizational) and organizational barriers (Individual and Organizational). The instrument will be completed by the school core teams and the subscale scores will be averaged to create an overall indicator of School Capacity.

次要结局

  • Average Weekly Tracking Rate (%); Web-based SWITCH tracking tool(Change from baseline to 12 weeks)
  • Adherence to Quality Element (average score); Checkpoint Implementation Survey(Change from baseline to 12 weeks)
  • Adherence to Best Practices (average score); Checkpoint Implementation Survey(Change from baseline to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gregory Welk

Barbara E. Forker Professor of Kinesiology

Iowa State University

研究点 (2)

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