Clinical trial NCT04045288: SWITCH Implementation Effectiveness Trial
Official title: SWITCH Implementation Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Health Promotion
Overweight and Obesity
Healthy Lifestyle
Diet, Healthy
Keywords: School Wellness Policy
Professional Development
Comprehensive School Physical Activity Programs
Whole-of-School Intervention
Screen Time
Physical Activity
Lead sponsor: Iowa State University
Sponsor class: OTHER
Collaborators: name: Kansas State University
name: University of Nebraska
name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2019-08-05
Enrollment: 1984
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic Cluster Randomized Controlled Superiority Trial.
Primary purpose: PREVENTION

Brief summary: 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".

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.

Eligibility criteria: 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

Primary outcomes:
measure: Moderate to Vigorous Physical Activity (minutes / day); Youth Activity Profile (YAP) assessment
timeFrame: Change from baseline to 12 weeks
measure: Sedentary Behavior (hours / day); Youth Activity Profile (YAP) assessment
timeFrame: Change from baseline to 12 weeks
measure: School Capacity for Wellness Programming; School Wellness Readiness Assessment
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Average Weekly Tracking Rate (%); Web-based SWITCH tracking tool
timeFrame: Change from baseline to 12 weeks
measure: Adherence to Quality Element (average score); Checkpoint Implementation Survey
timeFrame: Change from baseline to 12 weeks
measure: Adherence to Best Practices (average score); Checkpoint Implementation Survey
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
affiliation: Iowa State University
name: Gregory J Welk, PhD
role: PRINCIPAL_INVESTIGATOR
References: