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临床试验/NCT03380143
NCT03380143已完成不适用

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

University of Nebraska1 个研究点 分布在 1 个国家目标入组 697 人开始时间: 2018年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
697
试验地点
1
主要终点
Change in minutes of moderate-to-vigorous physical activity assessed by accelerometer

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Standard Practice (Behavioral)

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).

干预措施: Wellness Landscape Intervention (Behavioral)

结局指标

主要结局

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

时间窗: 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

时间窗: 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

次要结局

  • Change in minutes of moderate-to-vigorous physical activity assessed by self-report(Baseline, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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