Physical ActivityNCT03380143
Whole-of-Community Youth Population Physical Activity
A study testing Wellness Landscape Intervention and Standard Practice in people with Physical Activity, run by University of Nebraska at 1 site in United States.
Trial summary
This study will evaluate the impact of a whole-of-community multi-level adaptive systems intervention on implementation of community change and youth population physical activity. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Wellness Landscape Intervention and Standard Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 697 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 1 Jan 2024
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Community located in rural micropolitan area
- Community is a one high school town
- Organization is a school district
- Organization is a after school program
- Organization is a youth club system
- Organization is a youth sport delivery system
- Leaders of settings in school, after-school, club, and youth sport
- 3rd through 6th grade settings and children within
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Whole-of-Community Systems Intervention for Youth Population Physical Activity
This study will evaluate the impact of a whole-of-community multi-level adaptive systems intervention on implementation of community change and youth population physical activity. Building on local health department partnerships, the investigators will conduct a two-wave staggered-start community randomized trial with four volunteer rural communities (each having nested school, after-school, scouting/4-H club, youth sport organizations) randomly assigned to intervention or standard public health practice.
Read the detailed description
The underlying conditions where youth live are associated with population health outcomes, with rural communities facing under-studied challenges. Youth physical activity (PA), a key risk factor linked to later cancer occurrence, is an outcome of community conditions. The proposed work will address a critical public health need by evaluating the impact of a whole-of-community multi-level adaptive systems intervention on implementation of community change and youth population PA. The intervention, Wellscapes, is based on a hierarchical patch dynamics paradigm, given that communities are "wellness landscapes" of spatially heterogeneous geographic areas, characterized by a patchwork of interacting organization and activity settings. The intervention will establish a multi-level system infrastructure (Community Hub, Organization Wellness Teams, Activity Setting/Leaders) and provide training and support for population health quality improvement cycle processes targeting two evidence-based practices (EBPs): (1) stacking time segments of PA episodes within an organization's daily routine, and (2) improving the quality of PA episodes (% time in PA). The omnibus hypothesis is that intervention communities (plus organizations and leaders nested within) will have synergy and capacity to implement EBPs, adapting to continuously changing local system drivers to create a whole-of-community ecosystem of diverse and equitable youth PA opportunities. Building on local health department partnerships, the investigators will conduct a two-wave staggered-start community randomized trial with four volunteer rural communities (each having nested school, after-school, scouting/4-H club, youth sport organizations) randomly assigned to intervention or standard public health practice. For baseline and intervention years, one day per month in the fall (3 days) and spring (3 days), organization activity settings (e.g., classrooms, teams) that house 480 children in 3rd through 6th grades will be assessed, resulting in observed community condition data, PA accelerometer data, and setting reach data (children % attendance by gender, ethnicity, free/reduced lunch status, and grade). The investigators will also obtain estimates of population level PA with the use of the calibrated Youth Activity Profile, as well as community system qualitative data. The specific aims are to: (1) Determine the impact of the intervention on multi-level community system outcomes; and (2) Determine the implementation system drivers of multi-level youth population PA. The investigators will use "big data" multi- level modeling methods for this effectiveness-implementation hybrid design, because there is a dual focus on testing an implementation strategy while simultaneously evaluating youth population PA impact. The research is significant because it evaluates a method for improving population health, theory-based systems, and behavior change processes in low-resource rural communities. The proposed research is novel because the adaptive patch dynamics approach builds capacity for both equitable collaboration and EBPs implementation across multiple local systems that are individually and collectively, dynamic and unpredictable.
- Conditions
- Physical Activity
- Being tested
- Wellness Landscape Intervention, Standard Practice
- Keywords
- Children, Cancer Prevention, Population Health, Rural, Community, School, After School, Youth Sport, Intervention, Multilevel, Systems
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Landscape InterventionBehavioural
Also called Wellscapes
Community and organization systems intervention targeting youth population physical activity
Standard PracticeBehavioural
Also called Collective Impact
Community development intervention
| Study group | Role | What they receive |
|---|---|---|
| Wellscapes Intervention | Experimental | The wellness landscape intervention (Wellscapes) will establish a multi-level system infrastructure (Community Hub, Organization Wellness Teams, Activity Setting/Leaders) and provide training and support for population health quality improvement cycle processes targeting two evidence-based practices (EBPs): (1) stacking time segments of PA episodes within an organization's daily routine, and (2) improving the quality of PA episodes (% time in PA). Receives: Behavioral: Wellness Landscape Intervention |
| Standard Practice | Active comparator | The standard collective impact public health practice intervention will establish a multi-level system infrastructure and provide training on community development. Receives: Behavioral: Standard Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minutes of moderate-to-vigorous physical activity assessed by accelerometer
Average of school class, after-school class, youth club meeting, and youth sport practice physical activity
Measured: Baseline, 12 months
Change in frequency of implemented episode sessions of physical activity assessed by observation
Average of observed frequency of implemented physical activity episodes in school class, after-school class, youth club meeting, and youth sport practices
Measured: Baseline, 12 months
Secondary outcomes (1)
Change in minutes of moderate-to-vigorous physical activity assessed by self-report
Youth Physical Activity Profile
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start5 Sep 2018
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- This design can be described as a staggered-start, stepped-wedge, community randomized trial. The design includes two sequential intervention waves.
- Masking
- None (open label)
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Iowa State University, Kansas State University
- Responsible party
- Sponsor
- Investigators
- David A Dzewaltowski, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380143
- Sponsor's protocol ID
- 0446-18-EP
- Status last verified
- Aug 2024
- First submitted
- 6 Dec 2017
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for all primary and secondary outcome measures will be made available.
Publications
Kellstedt DK, Schenkelberg MA, Essay AM, Welk GJ, Rosenkranz RR, Idoate R, Ramos AK, Grimm B, Dzewaltowski DA. Rural community systems: Youth physical activity promotion through community collaboration. Prev Med Rep. 2021 Jul 6;23:101486. doi: 10.1016/j.pmedr.2021.101486. eCollection 2021 Sep.
PubMed 34458077Kellstedt DK, Schenkelberg MA, Essay AM, Von Seggern MJ, Rosenkranz RR, Welk GJ, High R, Dzewaltowski DA. Youth sport participation and physical activity in rural communities. Arch Public Health. 2021 Apr 8;79(1):46. doi: 10.1186/s13690-021-00570-y.
PubMed 33832548Schenkelberg MA, Essay AM, Rosen MS, Bavari AE, Norgelas SJ, Rosenkranz RR, Welk GJ, Dzewaltowski DA. A protocol for coordinating rural community stakeholders to implement whole-of-community youth physical activity surveillance through school systems. Prev Med Rep. 2021 Aug 26;24:101536. doi: 10.1016/j.pmedr.2021.101536. eCollection 2021 Dec.
PubMed 34976611Essay AM, Schenkelberg MA, Von Seggern MJ, Rosen MS, Schlechter CR, Rosenkranz RR, Dzewaltowski DA. A Protocol for a Local Community Monitoring and Feedback System for Physical Activity in Organized Group Settings for Children. J Phys Act Health. 2023 Mar 25;20(5):385-393. doi: 10.1123/jpah.2022-0486. Print 2023 May 1.
PubMed 36965493Kellstedt DK, Essay AM, Schenkelberg MA, Rosen MS, Von Seggern MJ, Idoate R, Welk GJ, Rosenkranz RR, Dzewaltowski DA. COVID-19 pandemic and changes in children's physical activity in a rural US community: a mixed methods study. BMJ Open. 2022 Oct 27;12(10):e062987. doi: 10.1136/bmjopen-2022-062987.
PubMed 36302579Rogers AE, Wichman CS, Schenkelberg MA, Dzewaltowski DA. Inequality in Physical Activity in Organized Group Settings for Children: A Cross-Sectional Study. J Phys Act Health. 2024 Aug 8;21(9):939-949. doi: 10.1123/jpah.2024-0053. Print 2024 Sep 1.
PubMed 39117309Rosen MS, Rogers AE, J Von Seggern M, Grimm BL, Ramos AK, Schenkelberg MA, Idoate RE, Dzewaltowski DA. Investigate-Design-Practice-Reflect: An Iterative Community-Engaged Action Process to Improve Population Health. J Community Health. 2024 Dec;49(6):1106-1117. doi: 10.1007/s10900-024-01385-y. Epub 2024 Aug 7.
PubMed 39110360Rogers AE, Wichman CS, Schenkelberg MA, Dzewaltowski DA. Inequality in Children's Physical Activity Across Time-Segmented Youth Sport Practice. Res Q Exerc Sport. 2025 Mar;96(1):96-108. doi: 10.1080/02701367.2024.2367565. Epub 2024 Jul 11.
PubMed 38990545Von Seggern MJ, Rogers AE, Schenkelberg MA, Kellstedt DK, Welk GJ, High R, Dzewaltowski DA. Sociodemographic influences on youth sport participation and physical activity among children living within concentrated Hispanic/Latino rural communities. Front Public Health. 2024 Feb 21;12:1345635. doi: 10.3389/fpubh.2024.1345635. eCollection 2024.
PubMed 38450148
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-of-Community Systems Intervention for Youth Population Physical Activity
- ClinicalTrials.gov ID
- NCT03380143
- Acronym / sponsor ID
- 0446-18-EP
- Conditions
- Physical Activity
- Keywords
- Children, Cancer Prevention, Population Health, Rural, Community, School, After School, Youth Sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Iowa State University, Kansas State University
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 20 Dec 2017 (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.
This study will evaluate the impact of a whole-of-community multi-level adaptive systems intervention on implementation of community change and youth population physical activity. Building on local health department partnerships, the investigators will conduct a two-wave staggered-start community randomized trial with four volunteer rural communities (each having nested school, after-school, scouting/4-H club, youth sport organizations) randomly assigned to intervention or standard public health practice.
Detailed description
The underlying conditions where youth live are associated with population health outcomes, with rural communities facing under-studied challenges. Youth physical activity (PA), a key risk factor linked to later cancer occurrence, is an outcome of community conditions. The proposed work will address a critical public health need by evaluating the impact of a whole-of-community multi-level adaptive systems intervention on implementation of community change and youth population PA. The intervention, Wellscapes, is based on a hierarchical patch dynamics paradigm, given that communities are "wellness landscapes" of spatially heterogeneous geographic areas, characterized by a patchwork of interacting organization and activity settings. The intervention will establish a multi-level system infrastructure (Community Hub, Organization Wellness Teams, Activity Setting/Leaders) and provide training and support for population health quality improvement cycle processes targeting two evidence-based practices (EBPs): (1) stacking time segments of PA episodes within an organization's daily routine, and (2) improving the quality of PA episodes (% time in PA). The omnibus hypothesis is that intervention communities (plus organizations and leaders nested within) will have synergy and capacity to implement EBPs, adapting to continuously changing local system drivers to create a whole-of-community ecosystem of diverse and equitable youth PA opportunities. Building on local health department partnerships, the investigators will conduct a two-wave staggered-start community randomized trial with four volunteer rural communities (each having nested school, after-school, scouting/4-H club, youth sport organizations) randomly assigned to intervention or standard public health practice. For baseline and intervention years, one day per month in the fall (3 days) and spring (3 days), organization activity settings (e.g., classrooms, teams) that house 480 children in 3rd through 6th grades will be assessed, resulting in observed community condition data, PA accelerometer data, and setting reach data (children % attendance by gender, ethnicity, free/reduced lunch status, and grade). The investigators will also obtain estimates of population level PA with the use of the calibrated Youth Activity Profile, as well as community system qualitative data. The specific aims are to: (1) Determine the impact of the intervention on multi-level community system outcomes; and (2) Determine the implementation system drivers of multi-level youth population PA. The investigators will use "big data" multi- level modeling methods for this effectiveness-implementation hybrid design, because there is a dual focus on testing an implementation strategy while simultaneously evaluating youth population PA impact. The research is significant because it evaluates a method for improving population health, theory-based systems, and behavior change processes in low-resource rural communities. The proposed research is novel because the adaptive patch dynamics approach builds capacity for both equitable collaboration and EBPs implementation across multiple local systems that are individually and collectively, dynamic and unpredictable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This design can be described as a staggered-start, stepped-wedge, community randomized trial. The design includes two sequential intervention waves.
| Arm | Type | Receives |
|---|---|---|
| Wellscapes Intervention | Experimental | Behavioral: Wellness Landscape InterventionThe wellness landscape intervention (Wellscapes) will establish a multi-level system infrastructure (Community Hub, Organization Wellness Teams, Activity Setting/Leaders) and provide training and support for population health quality improvement cycle processes targeting two evidence-based practices (EBPs): (1) stacking time segments of PA episodes within an organization's daily routine, and (2) improving the quality of PA episodes (% time in PA). |
| Standard Practice | Active comparator | Behavioral: Standard PracticeThe standard collective impact public health practice intervention will establish a multi-level system infrastructure and provide training on community development. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Community located in rural micropolitan area
- Community is a one high school town
- Organization is a school district
- Organization is a after school program
- Organization is a youth club system
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Wellness Landscape InterventionAlso: WellscapesCommunity and organization systems intervention targeting youth population physical activity | Behavioural | Wellscapes Intervention |
| Standard PracticeAlso: Collective ImpactCommunity development intervention | Behavioural | Standard Practice |
Primary outcome
Change in minutes of moderate-to-vigorous physical activity assessed by accelerometer
Time frame: Baseline, 12 months
Average of school class, after-school class, youth club meeting, and youth sport practice physical activity
Change in frequency of implemented episode sessions of physical activity assessed by observation
Time frame: Baseline, 12 months
Average of observed frequency of implemented physical activity episodes in school class, after-school class, youth club meeting, and youth sport practices
1 secondary outcome
Change in minutes of moderate-to-vigorous physical activity assessed by self-report
Time frame: Baseline, 12 months
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 Sep 2024.
- Background: PubMed 34458077Kellstedt DK, Schenkelberg MA, Essay AM, Welk GJ, Rosenkranz RR, Idoate R, Ramos AK, Grimm B, Dzewaltowski DA. Rural community systems: Youth physical activity promotion through community collaboration. Prev Med Rep. 2021 Jul 6;23:101486. doi: 10.1016/j.pmedr.2021.101486. eCollection 2021 Sep.
- Background: PubMed 33832548Kellstedt DK, Schenkelberg MA, Essay AM, Von Seggern MJ, Rosenkranz RR, Welk GJ, High R, Dzewaltowski DA. Youth sport participation and physical activity in rural communities. Arch Public Health. 2021 Apr 8;79(1):46. doi: 10.1186/s13690-021-00570-y.
- Background: PubMed 34976611Schenkelberg MA, Essay AM, Rosen MS, Bavari AE, Norgelas SJ, Rosenkranz RR, Welk GJ, Dzewaltowski DA. A protocol for coordinating rural community stakeholders to implement whole-of-community youth physical activity surveillance through school systems. Prev Med Rep. 2021 Aug 26;24:101536. doi: 10.1016/j.pmedr.2021.101536. eCollection 2021 Dec.
- Background: PubMed 36965493Essay AM, Schenkelberg MA, Von Seggern MJ, Rosen MS, Schlechter CR, Rosenkranz RR, Dzewaltowski DA. A Protocol for a Local Community Monitoring and Feedback System for Physical Activity in Organized Group Settings for Children. J Phys Act Health. 2023 Mar 25;20(5):385-393. doi: 10.1123/jpah.2022-0486. Print 2023 May 1.
- Background: PubMed 36302579Kellstedt DK, Essay AM, Schenkelberg MA, Rosen MS, Von Seggern MJ, Idoate R, Welk GJ, Rosenkranz RR, Dzewaltowski DA. COVID-19 pandemic and changes in children's physical activity in a rural US community: a mixed methods study. BMJ Open. 2022 Oct 27;12(10):e062987. doi: 10.1136/bmjopen-2022-062987.
- Derived from this study: PubMed 39117309Rogers AE, Wichman CS, Schenkelberg MA, Dzewaltowski DA. Inequality in Physical Activity in Organized Group Settings for Children: A Cross-Sectional Study. J Phys Act Health. 2024 Aug 8;21(9):939-949. doi: 10.1123/jpah.2024-0053. Print 2024 Sep 1.
- Derived from this study: PubMed 39110360Rosen MS, Rogers AE, J Von Seggern M, Grimm BL, Ramos AK, Schenkelberg MA, Idoate RE, Dzewaltowski DA. Investigate-Design-Practice-Reflect: An Iterative Community-Engaged Action Process to Improve Population Health. J Community Health. 2024 Dec;49(6):1106-1117. doi: 10.1007/s10900-024-01385-y. Epub 2024 Aug 7.
- Derived from this study: PubMed 38990545Rogers AE, Wichman CS, Schenkelberg MA, Dzewaltowski DA. Inequality in Children's Physical Activity Across Time-Segmented Youth Sport Practice. Res Q Exerc Sport. 2025 Mar;96(1):96-108. doi: 10.1080/02701367.2024.2367565. Epub 2024 Jul 11.
- Derived from this study: PubMed 38450148Von Seggern MJ, Rogers AE, Schenkelberg MA, Kellstedt DK, Welk GJ, High R, Dzewaltowski DA. Sociodemographic influences on youth sport participation and physical activity among children living within concentrated Hispanic/Latino rural communities. Front Public Health. 2024 Feb 21;12:1345635. doi: 10.3389/fpubh.2024.1345635. eCollection 2024.
- Individual participant dataSharing planned: Yes. De-identified data for all primary and secondary outcome measures will be made available.
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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.
David A Dzewaltowski, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Landscape Intervention and Standard Practice in people with Physical Activity, run by University of Nebraska 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 8 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 Sep 2024. 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?
Change in minutes of moderate-to-vigorous physical activity assessed by accelerometer (time frame: Baseline, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03380143, which also lists 9 linked publications.
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 Sep 2024.