Whole-of-Community Youth Population Physical Activity

• ClinicalTrials.gov Identifier: NCT03380143
• Recruitment Status: Enrolling by invitation
• First Posted: December 20, 2017
• Last Update Posted: November 8, 2022
• Sponsor: University of Nebraska
• Collaborators: Iowa State University; Kansas State University
• Information provided by (Responsible Party): David Dzewaltowski, Ph.D., University of Nebraska

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Physical Activity	Behavioral: Wellness Landscape Intervention; Behavioral: Standard Practice	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Prevention
• Official Title: Whole-of-Community Systems Intervention for Youth Population Physical Activity
• Actual Study Start Date: September 5, 2018
• Estimated Primary Completion Date: January 1, 2024
• Estimated Study Completion Date: January 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Wellscapes Intervention; 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; Community and organization systems intervention targeting youth population physical activity; Other Name: Wellscapes
Active Comparator: Standard Practice; 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 development intervention; Other Name: Collective Impact

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. Change in minutes of moderate-to-vigorous physical activity assessed by self-report [ Time Frame: Baseline, 12 months ]
   Youth Physical Activity Profile

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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:

-

Contacts and Locations

Locations

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Sponsors and Collaborators

University of Nebraska

Iowa State University

Kansas State University

Investigators

• Principal Investigator: David A Dzewaltowski, Ph.D.; University of Nebraska

More Information

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: David Dzewaltowski, Ph.D., Professor, University of Nebraska
• ClinicalTrials.gov Identifier: NCT03380143
• Other Study ID Numbers: 446-18
• First Posted: December 20, 2017
• Last Update Posted: November 8, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified data for all primary and secondary outcome measures will be made available.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Dzewaltowski, Ph.D., University of Nebraska:

Children; Cancer Prevention; Population Health; Rural; Community; School; After School; Youth Sport; Intervention; Multilevel; Systems