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Набор скоро начнётся NCT07061665

Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN

Без фазы С лечением Quality of Life (QOL) Nutrition Physical Activity Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Multi-level, Multi-component Intervention Package.
Кому может быть актуально
Состояния в реестре: Quality of Life (QOL), Nutrition, Physical Activity, Obesity. Базовые параметры: 6 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

  • Поведенческое 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 inform

Первичные конечные точки

  • Body mass index z-score (BMI-z) adjusted for age and sex [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up (2025-2027)]
Вторичные конечные точки (1)
  • Health-Related Quality of Life (HRQoL) [Срок оценки: Baseline, 1-year follow-up, 2-year follow-up (2025-2027)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Япония · 1 центр
  • Chiba University — Chiba

Идентификаторы

NCT: NCT07061665 · M10825

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗