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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

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE December 20, 2017
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE September 5, 2018
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03380143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
Change in minutes of moderate-to-vigorous physical activity assessed by self-report [ Time Frame: Baseline, 12 months ]
Youth Physical Activity Profile
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whole-of-Community Systems Intervention for Youth Population Physical Activity
Official Title  ICMJE Whole-of-Community Systems Intervention for Youth Population Physical Activity
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Physical Activity
Intervention  ICMJE
  • Behavioral: Wellness Landscape Intervention
    Community and organization systems intervention targeting youth population physical activity
    Other Name: Wellscapes
  • Behavioral: Standard Practice
    Community development intervention
    Other Name: Collective Impact
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Wellness Landscape Intervention
  • 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.
    Intervention: Behavioral: Standard Practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: December 15, 2017)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2023
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03380143
Other Study ID Numbers  ICMJE 1R01CA215420-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Responsible Party David Dzewaltowski, Ph.D., University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE
  • Iowa State University
  • Kansas State University
Investigators  ICMJE
Principal Investigator: David A Dzewaltowski, Ph.D. University of Nebraska
PRS Account University of Nebraska
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP