- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04045288
SWITCH Implementation Effectiveness Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Iowa
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Ames, Iowa, United States, 50011
- Iowa State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All students in schools who completed agreement forms and who formed a three-person core team that attended the conference
Exclusion Criteria:
- All students in schools that did not complete agreement forms, attend the school wellness conference, or form a core team
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Implementation
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.
|
Schools in the Standard implementation model received web-based training, access to on online education / tracking system and programming resources (modules, posters, trinkets) to facilitate wellness programming in their school.
They completed audit tools at the beginning to facilitate goal setting and received weekly emails during the 12-week implementation process.
|
Experimental: Enhanced Implementation
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.
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Schools in the Standard implementation model received web-based training, access to on online education / tracking system and programming resources (modules, posters, trinkets) to facilitate wellness programming in their school.
They completed audit tools at the beginning to facilitate goal setting and received weekly emails during the 12-week implementation process.
Schools in the Enhanced implementation model received the same training, web-access, and programming resources as those in the Standard implementation, but also received enhanced monthly support during implementation from the project team.
The supplemental web calls (completed jointly by Extension leaders and SWITCH staff) utilized motivational interviewing to help schools build capacity and to enhance motivation for wellness programming.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate to Vigorous Physical Activity (minutes / day); Youth Activity Profile (YAP) assessment
Time Frame: Change from baseline to 12 weeks
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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.
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Change from baseline to 12 weeks
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Sedentary Behavior (hours / day); Youth Activity Profile (YAP) assessment
Time Frame: Change from baseline to 12 weeks
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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.
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Change from baseline to 12 weeks
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School Capacity for Wellness Programming; School Wellness Readiness Assessment
Time Frame: 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.
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Change from baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Weekly Tracking Rate (%); Web-based SWITCH tracking tool
Time Frame: Change from baseline to 12 weeks
|
Indicators of school, class and student implementation are obtained by computing engagement and utilization of the web-based SWITCH tracking system.
Self-monitoring is a key mediating variable in the SWITCH program, so emphasis in training was placed on helping to promote utilization of the SWITCH tracking system to promote behavior change in the three target behaviors: PA ("do"), SB ("view"), and FV consumption ("chew").
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Change from baseline to 12 weeks
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Adherence to Quality Element (average score); Checkpoint Implementation Survey
Time Frame: Change from baseline to 12 weeks
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The Checkpoint Implementation Surveys (CIS) were used in a formative way to guide to evaluate the degree to which schools followed the SWITCH 'quality elements' for overall school implementation.
School teams self-reported the degree to which they followed each of the five quality elements using a 3-point scale (none = 1, somewhat = 2, and fully = 3).
The average score was used as the overall indicator
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Change from baseline to 12 weeks
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Adherence to Best Practices (average score); Checkpoint Implementation Survey
Time Frame: Change from baseline to 12 weeks
|
The Checkpoint Implementation Surveys (CIS) were used in a formative way to guide to evaluate the degree to which schools followed the SWITCH 'best practices' in the three targeted settings (classrooms, physical education, and lunchroom).
School teams self-reported the degree to which their school followed the 3 best practices in each setting using a 3-point scale (none = 1, somewhat = 2, and fully = 3).
The average score is used as an overall indicator.
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Change from baseline to 12 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregory J Welk, PhD, Iowa State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-68001-23242
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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