NCT04045288

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,984

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

July 31, 2019

Last Update Submit

August 1, 2019

Conditions

Keywords

School Wellness PolicyProfessional DevelopmentComprehensive School Physical Activity ProgramsWhole-of-School InterventionScreen TimePhysical Activity

Outcome Measures

Primary Outcomes (3)

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

    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.

    Change from baseline to 12 weeks

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

    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.

    Change from baseline to 12 weeks

  • School Capacity for Wellness Programming; School Wellness Readiness Assessment

    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.

    Change from baseline to 12 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

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.

Behavioral: Standard Implementation

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.

Behavioral: Standard ImplementationBehavioral: Enhanced Implementation

Interventions

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.

Enhanced ImplementationStandard Implementation

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.

Enhanced Implementation

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorOverweightObesityMotor Activity

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gregory J Welk, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pragmatic Cluster Randomized Controlled Superiority Trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Barbara E. Forker Professor of Kinesiology

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 5, 2019

Study Start

August 15, 2017

Primary Completion

May 1, 2018

Study Completion

May 15, 2018

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations