Whole-of-Community Youth Population Physical Activity

August 30, 2024 updated by: University of Nebraska

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

697

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 12 months
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
Baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in minutes of moderate-to-vigorous physical activity assessed by self-report
Time Frame: Baseline, 12 months
Youth Physical Activity Profile
Baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Kansas State University
Iowa State University

Investigators

  • Principal Investigator: David A Dzewaltowski, PhD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2018

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0446-18-EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be made available within 1 year of study completion.

IPD Sharing Access Criteria

Data access will be reviewed by investigator team. Requesters will be required to sign data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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