Whole-of-Community Youth Population Physical Activity

Physical Activity Clinical Trial

Official title:

Whole-of-Community Systems Intervention for Youth Population Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380143
• Other study ID #: 0446-18-EP
• Status: Completed
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 697
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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 Exclusion Criteria: -

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Wellness Landscape Intervention
Community and organization systems intervention targeting youth population physical activity
• Standard Practice
Community development intervention

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
University of Nebraska	Iowa State University, Kansas State University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Essay 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. — View Citation

Kellstedt 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. — View Citation

Kellstedt 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. — View Citation

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. — View Citation

Schenkelberg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 12 months
Primary	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	Baseline, 12 months
Secondary	Change in minutes of moderate-to-vigorous physical activity assessed by self-report	Youth Physical Activity Profile	Baseline, 12 months