NCT03380143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
697

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 5, 2024

Status Verified

August 1, 2024

Enrollment Period

5.3 years

First QC Date

December 6, 2017

Last Update Submit

August 30, 2024

Conditions

Physical Activity

Keywords

ChildrenCancer PreventionPopulation HealthRuralCommunitySchoolAfter SchoolYouth SportInterventionMultilevelSystems

Outcome Measures

Primary Outcomes (2)

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

    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

    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 Outcomes (1)

  • Change in minutes of moderate-to-vigorous physical activity assessed by self-report

    Baseline, 12 months

Study Arms (2)

Wellscapes Intervention

EXPERIMENTAL

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

Standard Practice

ACTIVE COMPARATOR

The standard collective impact public health practice intervention will establish a multi-level system infrastructure and provide training on community development.

Behavioral: Standard Practice

Interventions

Wellness Landscape InterventionBEHAVIORAL

Community and organization systems intervention targeting youth population physical activity

Also known as: Wellscapes
Wellscapes Intervention
Standard PracticeBEHAVIORAL

Community development intervention

Also known as: Collective Impact
Standard Practice

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • rd through 6th grade settings and children within

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (7)

  • 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.

    PMID: 34458077BACKGROUND

  • 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.

    PMID: 33832548BACKGROUND

  • 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.

    PMID: 34976611BACKGROUND

  • Essay AM, Schenkelberg MA, Von Seggern MJ, Rosen MS, Schlechter CR, Rosenkranz RR, Dzewaltowski DA. A Protocol for a Local Community Monitoring and Feedback System for Physical Activity in Organized Group Settings for Children. J Phys Act Health. 2023 Mar 25;20(5):385-393. doi: 10.1123/jpah.2022-0486. Print 2023 May 1.

    PMID: 36965493BACKGROUND

  • 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.

    PMID: 36302579BACKGROUND

  • Rogers AE, Wichman CS, Schenkelberg MA, Dzewaltowski DA. Inequality in Children's Physical Activity Across Time-Segmented Youth Sport Practice. Res Q Exerc Sport. 2025 Mar;96(1):96-108. doi: 10.1080/02701367.2024.2367565. Epub 2024 Jul 11.

    PMID: 38990545DERIVED

  • Von Seggern MJ, Rogers AE, Schenkelberg MA, Kellstedt DK, Welk GJ, High R, Dzewaltowski DA. Sociodemographic influences on youth sport participation and physical activity among children living within concentrated Hispanic/Latino rural communities. Front Public Health. 2024 Feb 21;12:1345635. doi: 10.3389/fpubh.2024.1345635. eCollection 2024.

    PMID: 38450148DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • David A Dzewaltowski, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This design can be described as a staggered-start, stepped-wedge, community randomized trial. The design includes two sequential intervention waves.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 20, 2017

Study Start

September 5, 2018

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

September 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations

US(1)