An interventional study of Wellness Landscape Intervention and Standard Practice in Physical Activity, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by University of Nebraska · Not applicable, Interventional, and Prevention
Among 19 studies in Motor Activity by University of Nebraska — none open to participants now, none under way, none of them phase 3. Motor Activity · University of Nebraska.
Among the 19 studies in Motor Activity by University of Nebraska, this one has the largest enrollment of the 14 interventional ones that give a count, is the only one that started in 2018, is one of 12 with no phase, and was the 11th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →None of the 19 studies in Motor Activity by University of Nebraska is open now.
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 7 Years to 12 Years · all sexes · healthy volunteers too.
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19 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2018.
This study's enrollment of 697 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 25 across the 14 interventional studies, 35 across the 5 observational. Of the 19 that completed or were terminated, 3 (16%) have results posted.
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University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 19 studies in Motor Activity by University of Nebraska, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Exclusion Criteria:
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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).
Behavioral: Wellness Landscape Intervention
The standard collective impact public health practice intervention will establish a multi-level system infrastructure and provide training on community development.
Behavioral: Standard Practice
Community and organization systems intervention targeting youth population physical activity
Also known as: Wellscapes
Community development intervention
Also known as: Collective Impact
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
Time frame: 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
Time frame: Baseline, 12 months
Change in minutes of moderate-to-vigorous physical activity assessed by self-report
Youth Physical Activity Profile
Time frame: Baseline, 12 months
Plan to share: Yes — De-identified data for all primary and secondary outcome measures will be made available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be made available within 1 year of study completion.
Access criteria: Data access will be reviewed by investigator team. Requesters will be required to sign data access agreement.
Ran from Sep 2018 to primary completion in Jan 2024, 63 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 63 months is above that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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