Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multi-level, Multi-component Intervention Package.
- Who it may be relevant to
- Registry conditions: Quality of Life (QOL), Nutrition, Physical Activity, Obesity. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Multi-level, Multi-component Intervention Package
The CBH COPI intervention applies multi-level strategies to improve children's environments and foster healthy behaviors. In schools, activities include schoolyard enhancements (e.g., hopscotch), inter-school sports events, nutrition lectures, healthy snacks, and educational materials linking health and academics. In parks and roads, improvements include cycling/walking promotions, signage, healthier vending machines, and community events. Supermarkets support healthy choices through menu inform
Primary outcome measures
- Body mass index z-score (BMI-z) adjusted for age and sex [Time frame: Baseline, 1-year follow-up, 2-year follow-up (2025-2027)]
Secondary outcome measures (1)
- Health-Related Quality of Life (HRQoL) [Time frame: Baseline, 1-year follow-up, 2-year follow-up (2025-2027)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Japan · 1 center
- Chiba University — Chiba
Identifiers
NCT: NCT07061665 · M10825