Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN (NCT07061665) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Japan2,200 participantsStarted 2025-07
Plain-language summary
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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body mass index z-score (BMI-z) adjusted for age and sex