About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Multi-level, Multi-component Intervention Package
Treatment groups
Sponsors and collaborators
Chiba University
Lead sponsor
Novo Nordisk A/S
Collaborator
The Behavioural Insights Team
Collaborator
Delivery Associates
Collaborator