Weight Management Program for Obese Preschool Children
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: Family engaged, enhanced Diet intervention.
- Кому может быть актуально
- Состояния в реестре: Childhood Obesity. Базовые параметры: 4 лет — 6 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Peking University-Family Engaged, Enhanced Diet, for Kids (PKU-FeeD)
Обзор
The PKU-FeeD trial is a cluster-randomized controlled trial conducted in Jinan, Shandong Province, China. This study aims to: 1) Develop and evaluate a digital health-assisted, multidisciplinary intervention for preschool children with obesity, assessing its effectiveness and cost-effectiveness. 2) Investigate how lifestyle-based interventions influence the composition and function of the gut microbiota in obese preschoolers, and elucidate the mechanisms by which these interventions may modulate gut microbiota to affect obesity-related metabolic phenotypes.
Подробное описание
Childhood obesity has become a global public health challenge, and early prevention and management are crucial to curbing its epidemic. However, compared to school-aged children, evidence on effective obesity interventions for preschoolers remains limited and inconsistent. While preventive approaches may have broader population-level implications, targeted management interventions may be more cost-effective in settings with lower obesity prevalence but rising trends, providing foundational evidence for future preventive strategies.
The gut microbiota plays a key role in host energy metabolism and metabolic homeostasis, and its dysbiosis is strongly linked to obesity. Diet and physical activity, as core components of lifestyle interventions, may significantly shape gut microbial ecology, potentially influencing host metabolism and obesity-related outcomes. However, due to challenges in sample collection, existing studies on gut microbiota in children are scarce, with small sample sizes, and few intervention studies have established causal relationships. The interplay between healthy lifestyle interventions, gut microbiota, and childhood obesity remains understudied, and the underlying mechanisms require further exploration. Thus, this trial seeks to: 1) determine effectiveness of a digital health-supported, comprehensive intervention for preschool obesity management. 2) Elucidate causal relationships between dietary behaviors, gut microbiota, and obesity in preschoolers.
Вмешательства
- Поведенческое Family engaged, enhanced Diet intervention
The family component includes health education via books, lectures, and short videos, parenting skills training, regular monitoring of child growth, and behavior goal setting through the mobile health platform. Motivational interviewing via telephone provides tailored behavioral support. Kindergartens assist in health education, supervise dietary intake and physical activity, monitor children's growth monthly, and maintain communication with families. Hospitals provide targeted health counseli
Первичные конечные точки
- children's BMI-Z change [Срок оценки: at end of the 9-month intervention]
Вторичные конечные точки (12)
- children's BMI-Z change [Срок оценки: at 21-month follow-up.]
- Body Mass Index (BMI) [Срок оценки: at the end of the 9-month intervention; at 21-month follow-up.]
- Waist Circumference [Срок оценки: at the end of the 9-month intervention; at 21-month follow-up]
- waist-to-Height Ratio, WHtR [Срок оценки: at the end of the 9-month intervention; at 21-month follow-up.]
- Systolic and Diastolic Blood Pressures [Срок оценки: at the end of the 9-month intervention; at 21-month follow-up.]
- Body Composition [Срок оценки: at the end of the 9-month intervention]
- Prevalence and Incidence of Overweight/Obesity [Срок оценки: at the end of the 9-month intervention; at 21-month follow-up]
- Dietary Intake [Срок оценки: at the end of the 9-month intervention]
- Children's Eating Behaviors [Срок оценки: at the end of the 9-month intervention]
- Parental Feeding Practices (CPCFBS) [Срок оценки: at the end of the 9-month intervention]
- Time Spent in Physical Activity [Срок оценки: at the end of the 9-month intervention]
- Sedentary Behavior and Screen Time [Срок оценки: at the end of the 9-month intervention]
Критерии участия
Критерии включения
- The child's primary caregivers can proficiently use smart phones.
- Child is expected to remain in the same kindergarten for at least one year.
- No use of antibiotics or probiotic supplements, no acute stress events (e.g., trauma or severe infection), gastrointestinal symptoms (e.g., abdominal pain, constipation, diarrhea), or vaccinations within the 3 months prior to stool sample collection.
- Parents voluntarily agree to participate in the study and provide written informed consent.
Критерии исключения
- Obesity caused by genetic factors, diseases (e.g., endocrine disorders, central nervous system damage), or medication use.
- History of major organ diseases, including cardiovascular, pulmonary, hepatic, or renal conditions (e.g., heart disease, hypertension, asthma).
- Children following special diets (e.g., vegetarians).
- Children with pathological eating disorders or medical conditions that limit physical activity.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Department of Maternal and Child Health, School of Public Health — Пекин
Идентификаторы
NCT: NCT07126210 · IRB00001052-25071