Sedentary BehaviorNCT04045288
SWITCH Implementation Effectiveness Trial
A study testing Standard Implementation and Enhanced Implementation in people with Sedentary Behavior and Health Promotion, run by Iowa State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Health Promotion, Overweight and Obesity
- What is being tested?
- Standard Implementation and Enhanced Implementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,984 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 15 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All students in schools who completed agreement forms and who formed a three-person core team that attended the conference
Who cannot join
- All students in schools that did not complete agreement forms, attend the school wellness conference, or form a core team
Trial locations and contacts
1 site in 1 country.
About this study
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".
Read the 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.
- Conditions
- Sedentary Behavior, Health Promotion, Overweight and Obesity, Healthy Lifestyle, Diet, Healthy
- Being tested
- Standard Implementation, Enhanced Implementation
- Keywords
- School Wellness Policy, Professional Development, Comprehensive School Physical Activity Programs, Whole-of-School Intervention, Screen Time, Physical Activity
- Medical subject headings
- Sedentary Behavior, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ImplementationBehavioural
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 ImplementationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Implementation; Behavioral: Enhanced Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 12 weeks
Secondary outcomes (3)
Average Weekly Tracking Rate (%); Web-based SWITCH tracking tool
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").
Measured: Change from baseline to 12 weeks
Adherence to Quality Element (average score); Checkpoint Implementation Survey
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
Measured: Change from baseline to 12 weeks
Adherence to Best Practices (average score); Checkpoint Implementation Survey
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.
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start15 Aug 2017
- Primary completion1 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic Cluster Randomized Controlled Superiority Trial.
- Masking
- None (open label)
- Enrolment
- 1,984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas State University, University of Nebraska, Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Principal investigator, Gregory Welk, Iowa State University
- Investigators
- Gregory J Welk, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045288
- Sponsor's protocol ID
- 2015-68001-23242
- Other IDs
- 2015
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWITCH Implementation Effectiveness Trial
- ClinicalTrials.gov ID
- NCT04045288
- Acronym / sponsor ID
- 2015-68001-23242
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,984 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Collaborators
- Kansas State University, University of Nebraska, Louisiana State University Health Sciences Center in New Orleans
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic Cluster Randomized Controlled Superiority Trial.
| Arm | Type | Receives |
|---|---|---|
| Standard Implementation | Active comparator | Behavioral: Standard ImplementationAll 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. |
| Enhanced Implementation | Experimental | Behavioral: Standard Implementation, Behavioral: Enhanced ImplementationThe '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. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All students in schools who completed agreement forms and who formed a three-person core team that attended the conference
Key exclusion criteria (1 listed)
- All students in schools that did not complete agreement forms, attend the school wellness conference, or form a core team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ImplementationSchools 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. | Behavioural | Enhanced Implementation, Standard Implementation |
| Enhanced ImplementationSchools 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. | Behavioural | Enhanced Implementation |
Primary outcome
Moderate to Vigorous Physical Activity (minutes / day); Youth Activity Profile (YAP) assessment
Time frame: 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
Time frame: 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
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.
3 secondary outcomes
Average Weekly Tracking Rate (%); Web-based SWITCH tracking tool
Time frame: Change from baseline to 12 weeks
Adherence to Quality Element (average score); Checkpoint Implementation Survey
Time frame: Change from baseline to 12 weeks
Adherence to Best Practices (average score); Checkpoint Implementation Survey
Time frame: Change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory J Welk, PhD principal investigator
Iowa State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Implementation and Enhanced Implementation in people with Sedentary Behavior and Health Promotion, run by Iowa State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate to Vigorous Physical Activity (minutes / day); Youth Activity Profile (YAP) assessment (time frame: Change from baseline to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.