Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,200
- 试验地点
- 2
- 主要终点
- Body mass index z-score (BMI-z) adjusted for age and sex
研究概览
简要总结
The goal of this interventional study is to prevent childhood obesity in children aged 6-12 years in Chiba City, Japan. The main questions it aims to answer are:
- Does the multi-component intervention for environments around children reduce the BMI z-score of children aged 6-12 years after one and two years?
- Does the multi-component intervention for environments around children improve the health-related quality of life (assessed by KIDSCREEN-10) of children aged 6-12 years after one and two years?
Researchers will compare school clusters receiving the intervention to control clusters to see if the intervention package promotes healthy eating, increases physical activity, improves health-related quality of life, and reduces obesity prevalence.
Participants will:
- Attend elementary schools within participating clusters (either the intervention or control group).
- Have baseline data collected, with follow-up assessments after one year and two years.
- Potentially participate in school-based programs (nutrition education, physical activity promotion) and community-based initiatives (park activation, supermarkets) if in an intervention cluster.
- Have their physical activity and dietary behavior assessed through self-report questionnaires.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 to 12 years who are currently enrolled in one of the public elementary schools located within the 22 participating Junior High School District clusters in Chiba City.
- •The parent or legal guardian of each child must provide written informed consent prior to participation.
- •Parents or legal guardians must have sufficient Japanese language proficiency to understand study procedures, complete questionnaires, and provide accurate information during the study.
- •Children must be physically and cognitively capable of participating in school- and community-based activities involved in the intervention.
- •Participants must not have any medical conditions that would preclude safe participation in routine physical activities promoted by the intervention.
排除标准
- •Children whose parents or legal guardians fail to provide complete informed consent.
- •Families who withdraw consent at any point during the study period.
- •Children who independently express refusal to participate, even with parental consent.
- •Children with serious physical, psychological, or developmental disorders that prevent them from participating safely in the program's activities.
- •Families planning to relocate outside of Chiba City during the study period, making follow-up assessment infeasible.
结局指标
主要结局
Body mass index z-score (BMI-z) adjusted for age and sex
时间窗: Baseline, 1-year follow-up, 2-year follow-up (2025-2027)
The primary outcome is the BMI z-score, calculated using the WHO 2007 Growth Reference. This metric standardizes a child's relative weight status by adjusting for both age and sex, enabling comparisons across different age groups and sexes. It represents the number of standard deviations a child's BMI is from the mean BMI of a healthy reference population. The BMI z-score allows for monitoring obesity-related changes over time and assessing the intervention's effectiveness in preventing excessive weight gain. The use of this z-score ensures consistency with international standards, facilitating global comparison of childhood obesity trends. The analysis will focus on changes in BMI z-score from baseline to 1-year and 2-year follow-ups.
次要结局
- Health-Related Quality of Life (HRQoL)(Baseline, 1-year follow-up, 2-year follow-up (2025-2027))
研究者
Atsushi Nakagomi
Associate Professor
Chiba University