Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN (CBH COPI JAPAN)

Chiba University

Status: Not yet enrolling

Conditions: Physical Activity; Quality of Life (QOL); Nutrition; Childhood Obesity; Obesity

Treatments: Behavioral: Multi-level, Multi-component Intervention Package

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07061665

M10825

Details and patient eligibility

About

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.

Enrollment: 2,200 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,200 participants in 2 patient groups

Intervention Group

Experimental group

Description:

11 Junior High School District (JHSD) clusters in Chiba City receive a multi-level, multi-component intervention targeting individual, environmental, and community factors for childhood obesity prevention.

Treatment:

Behavioral: Multi-level, Multi-component Intervention Package

Control Group

No Intervention group

Description:

11 Junior High School District clusters in Chiba City serve as a comparator, continuing usual practices without new obesity prevention interventions from the study.