An interventional study of Multi-level, Multi-component Intervention Package and Elementary schools in Quality of Life (QOL), Nutrition and Physical Activity, sponsored by Chiba University. Recruiting at 1 site in Japan. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Chiba University · Not applicable, Interventional, and Prevention
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:
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:
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 2,200 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Chiba University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Compared within Pediatric Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Multi-level, Multi-component Intervention Package · Behavioral: Elementary schools · Behavioral: Parks · Behavioral: Ambassador Program · Behavioral: Home · Behavioral: Chiba University Academy
11 Junior High School District clusters in Chiba City serve as a comparator, continuing usual practices without new obesity prevention interventions from the study.
The CBH COPI intervention applies multi-level strategies to improve children's environments and foster healthy behaviors. The coordinated program aims to naturally promote healthy eating, physical activity, and sustained lifestyle change among children aged 6-12 in Chiba City.
In consultation with each elementary school, initiatives related to physical activity and diet will be implemented within the scope of the national curriculum guidelines. Super Hopscotch: Install foot-shaped signs and other markings on outdoor surfaces between the entrance/exit and school gates, as well as in the gymnasium-areas children frequent during daily school life. Place guides nearby explaining how to play and indicating difficulty levels, creating a safe and enjoyable play space. Playground Equipment Completion Card: Place numbered stickers on each piece of playground equipment, matching them to numbers on the completion card. Calendar-style Playground Equipment Completion Cards are distributed to children, who check off the numbers of the equipment they played on each day. Bug \& Find Journal: Distribute sketchbook-style "Bug \& Find Journals" to children. They sketch insects or flowers found that day.
In consultation with Chiba City, an environment that naturally encourages healthy choices will be fostered through modifications to city-managed facilities and awareness campaigns. Standing long jump: Mark a measurable distance for standing long jump on the pavement to create a fun and challenging environment. Slalom (line walking/running): Draw lines using shapes such as triangles, circles, and squares to create a path where children can walk or run along the line. Footprint maze: Children follow colored lines and shapes drawn on the ground to reach a goal, combining visual cues with physical movement. One-leg walking (balance walking): Place footprints on a curb about 10-20 cm wide, allowing children to move forward by alternating one leg along the footprints. Stair climbing: Display multiplication tables, English words, or phrases on the risers or sides of stairs to encourage children to climb them. And 25 m run, Hopscotch, Target throwing.
Children learn about food and lifestyle habits on their own, put them into action, and spread what they learn in the program to their families, schools, and communities. Target participants: Approximately 20 fourth- and fifth-grade elementary school students. Program components: * Learn \& Think: Understand the fundamentals of nutrition and the importance of healthy eating. * Experience: Apply nutrition knowledge through hands-on food-related activities. * Share \& Inspire: Communicate what they have learned and encourage healthy eating among peers and family members.
In consultation with each elementary school or community partner, support will be provided to foster healthy habits within each household. •Provide tools to manage lifestyle habits, including the habit-forming app "Min-Challe," which allows anonymous teams of up to five users with a shared goal to report their daily achievements to each other by sharing photos (https://minchalle.com/).
Target participants: Students from the intervention schools and the Chiba University Elementary School. * Three lectures are planned. * A Ken-Ken-Pa (hopscotch) course will be installed at the affiliated elementary school, or a simplified mat version will be used for hands-on activities. * An experiential booth will allow participants to experience the intervention components, with the aim of increasing the intensity and engagement of the intervention.
Body mass index z-score (BMI-z) adjusted for age and sex
The primary outcome is the BMI z-score, calculated using the WHO 2007 Growth Reference. This metric standardizes a child's relative weight status by adjusting for both age and sex, enabling comparisons across different age groups and sexes. It represents the number of standard deviations a child's BMI is from the mean BMI of a healthy reference population. The BMI z-score allows for monitoring obesity-related changes over time and assessing the intervention's effectiveness in preventing excessive weight gain. The use of this z-score ensures consistency with international standards, facilitating global comparison of childhood obesity trends. The analysis will focus on changes in BMI z-score from baseline to 1-year and 2-year follow-ups. The BMI z-score is a continuous measure without a fixed minimum or maximum; lower values indicate lower relative adiposity, so a decrease (or a smaller increase) represents a more favorable outcome for obesity prevention.
Time frame: Baseline, 1-year follow-up, 2-year follow-up (2025-2027)
Health-Related Quality of Life (HRQoL)
HRQoL will be assessed using the KIDSCREEN-10 index, a validated, self-reported measure capturing children's subjective well-being across physical, emotional, social, and school functioning. This 11-item scale uses a 5-point Likert response for each item, which is then converted into a standardized T-score, further transformed to a 0-100 scale. On this scale, higher scores indicate better perceived quality of life. Changes in KIDSCREEN-10 scores will be tracked from baseline through 1-year and 2-year follow-ups to evaluate the intervention's impact on children's overall well-being.
Time frame: Baseline, 1-year follow-up, 2-year follow-up (2025-2027)
Physical Activity
Physical activity will be assessed using self-reported daily minutes of moderate-to-vigorous physical activity (MVPA) and sedentary screen time. Participants will report time spent in activities such as sports, cycling, or active play, as well as screen-based sedentary behaviors. Data will be collected at baseline, 1-year, and 2-year follow-ups to evaluate the intervention's impact on physical activity patterns and sustained behavioral changes. Interpretation will be guided by international guidelines on daily activity targets. Physical activity is reported in minutes per day (no fixed maximum). Higher moderate-to-vigorous physical activity (MVPA) indicates a better outcome, whereas higher sedentary screen time indicates a worse outcome.
Time frame: Baseline, 1-year follow-up, 2-year follow-up (2025-2027)
Diet
Dietary outcomes will be assessed using the adapted Diet Quality Questionnaire (DQQ). This questionnaire evaluates children's usual intake of key food groups and dietary patterns. Participants or guardians will report the frequency of consuming various categories, including fruits, vegetables, whole grains, protein sources, dairy products, snacks, and sugary drinks. The DQQ aligns with global dietary guidelines and calculates scores reflecting dietary diversity and balance. Data will be collected at baseline, 1-year, and 2-year follow-ups to assess changes in dietary habits and the intervention's effects on promoting healthier eating patterns. The DQQ diet-quality score ranges from 0 to 18; higher scores indicate better diet quality (greater dietary diversity and adherence to dietary guidelines.
Time frame: Baseline, 1-year follow-up, 2-year follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual data will be shared with global collaborators (Novo Nordisk A/S, The Behavioural Insights Team, Oxford University) for pooled global analyses.
Supporting information: Study protocol
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chiba University