Whole-of-Community Youth Population Physical Activity

Sponsor

University of Nebraska (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03380143

Collaborator

Iowa State University (Other), Kansas State University (Other)

480

Enrollment

Location

Arms

57.8

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

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	Phase 3

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

Anticipated 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.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 :

Sep 5, 2018

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

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 Names: 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 Names: Collective Impact

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 Names:

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 Names:

Collective Impact

Outcome Measures

Primary Outcome Measures

Change in minutes of moderate-to-vigorous physical activity assessed by accelerometer [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 [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