Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN

NCT ID: NCT07061665

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-09-30

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Multi-level, Multi-component Intervention Package

Intervention Type: BEHAVIORAL

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 information, loyalty incentives, cooking classes, product placement, and healthy food sales. At home and in communities, the Min-Challe app supports habit formation, with athletes, mascots, and ambassadors promoting healthy living. The coordinated program aims to naturally promote healthy eating, physical activity, and sustained lifestyle change among children aged 6-12 in Chiba City.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 information, loyalty incentives, cooking classes, product placement, and healthy food sales. At home and in communities, the Min-Challe app supports habit formation, with athletes, mascots, and ambassadors promoting healthy living. The coordinated program aims to naturally promote healthy eating, physical activity, and sustained lifestyle change among children aged 6-12 in Chiba City.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

The Behavioural Insights Team

OTHER

Sponsor Role: collaborator

Delivery Associates

UNKNOWN

Sponsor Role: collaborator

Chiba University

OTHER

Sponsor Role: lead

Responsible Party

Atsushi Nakagomi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chiba University

Chiba, Chiba, Japan

Countries

Japan

Central Contacts

Atsushi Nakagomi, MD, PhD

Role: CONTACT

anakagomi0211@chiba-u.jp

+81-43-290-3177

Facility Contacts

LINGLING, PhD

Role: primary

cfka1470@chiba-u.jp

+81-43-290-3177

Other Identifiers

M10825

Identifier Type: -

Identifier Source: org_study_id