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临床试验/NCT07191925
NCT07191925进行中(未招募)不适用

An Evaluation of "Growing Healthy Places: Mississauga"

Brock University1 个研究点 分布在 1 个国家目标入组 4,900 人开始时间: 2025年10月16日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
4,900
试验地点
1
主要终点
Health-related Quality of Life as assessed by KIDSCREEN-10 index

研究概览

简要总结

The goal of this intervention study is to learn if community co-designed activities to improve diet and physical activity can impact the health of children ages 6-13 in Mississauga, Canada. The main questions it aims to answer are:

  1. Do the community co-designed interventions improve health-related quality of life of children after one year and two years?
  2. Do the community co-designed interventions improve the physical activity and eating behaviors of children after one year and two years?

Ten intervention and 12 control schools will take part in this study. The schools were recruited from the Mississauga area using an application process. Selection and group assignment involved a multi-stage process with initial randomization followed by manual adjustment (to balance groups on key observable characteristics and respond to stakeholder concerns about spillovers and implementation feasibility).

Researchers will compare students in schools that receive the interventions to students in schools that receive no interventions to see if the interventions improve health-related quality of life, increase physical activity and improve eating behaviors.

Participants will:

  • attend participating elementary or middle schools (in either intervention neighborhoods or control neighborhoods)
  • complete an anonymous questionnaire about their wellbeing, physical activity, and eating behaviors at baseline, after one year, and after two years
  • potentially participate in school and community programs (if in an intervention school neighborhood)

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
Single (Care Provider)

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Informed consent obtained by the child's parent or legal guardian before any study-related activities
  • Aged 6-13 years (both 6 and 13 allowed) at the time of signing consent
  • Enrolled in Grades 3-8 in one of the participating schools at the time of data collection

排除标准

  • Parent(s) or legal guardians do not provide fully informed consent
  • Parent(s) or legal guardians withdraw their consent for their child participating in the research
  • Child does not agree to participate on the data collection day

结局指标

主要结局

Health-related Quality of Life as assessed by KIDSCREEN-10 index

时间窗: Baseline, one-year follow-up, two-year follow-up.

Health-related quality of life will be proxied by the KIDSCREEN-10 scale, which is developed from 27-item KIDSCREEN-27 scale and assesses health-related quality of life on five dimensions: physical, psychological, autonomy and parent relations, peers and social support, school environment. Each item uses a 5-point Likert-style response based on how strong the respondent is feeling or the frequency of doing / feeling things over the last week. KIDSCREEN instruments were originally designed for ages 8-18 but have been validated in ages 6-18. Item wording is slightly adapted for typical Canadian phrasing. Responses to each item are coded 1-5, items scores are summed, and the total score is linearly transformed to a 0-100 scale. A higher score corresponds to a higher health-related quality of life.

次要结局

  • Average daily moderate-to-vigorous physical activity (MVPA)(Baseline, one-year follow-up, two-year follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Patte, PhD

Associate Professor, Health Sciences

Brock University

研究点 (1)

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