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

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ClinicalTrials.gov Identifier: NCT03380143
Recruitment Status : Enrolling by invitation
First Posted : December 20, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborators:
Iowa State University
Kansas State University
Information provided by (Responsible Party):
David Dzewaltowski, Ph.D., University of Nebraska

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.

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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 : July 1, 2022
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380143


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

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Responsible Party: David Dzewaltowski, Ph.D., Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT03380143     History of Changes
Other Study ID Numbers: 1R01CA215420-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
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.

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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