Peking University-Family Engaged, Enhanced Diet, for Kids (PKU-FeeD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- children's BMI-Z change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization will be performed after the baseline survey. The assessors measuring childrens' health indicators will be blinded at follow-up phases.
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
multicomponent intervention
This study adopts a multicomponent intervention based on the "3 Less, 2 More, 1 Team" approach-Less fried/fatty foods, less sugar, less overeating; More colorful foods, more physical activity; and One team (family working together to raise a healthy child). The intervention is family-centered, supported by kindergartens and hospitals, with digital health technology.
干预措施: Family engaged, enhanced Diet intervention (Behavioral)
usual-care control
In the control group, participating preschools will receive no intervention during the study period and will continue their routine educational and management practices without modification. After the study is fully completed, control group preschools will receive access to all intervention materials and health education resources developed for this project.
结局指标
主要结局
children's BMI-Z change
时间窗: at end of the 9-month intervention
Calculated based on height and weight using WHO standards. The primary outcome is the difference between two arms in the change of children's BMI-Z scores from baseline to the end of the intervention.
次要结局
- Time Spent in Physical Activity(at the end of the 9-month intervention)
- Gut Microbial Composition(at the end of the 9-month intervention)
- children's BMI-Z change(at 21-month follow-up.)
- Systolic and Diastolic Blood Pressures(at the end of the 9-month intervention; at 21-month follow-up.)
- Body Composition(at the end of the 9-month intervention)
- Body Mass Index (BMI)(at the end of the 9-month intervention; at 21-month follow-up.)
- Waist Circumference(at the end of the 9-month intervention; at 21-month follow-up)
- Children's Eating Behaviors(at the end of the 9-month intervention)
- waist-to-Height Ratio, WHtR(at the end of the 9-month intervention; at 21-month follow-up.)
- Prevalence and Incidence of Overweight/Obesity(at the end of the 9-month intervention; at 21-month follow-up)
- Dietary Intake(at the end of the 9-month intervention)
- Parental Feeding Practices (CPCFBS)(at the end of the 9-month intervention)
- Sedentary Behavior and Screen Time(at the end of the 9-month intervention)
研究者
Hai-Jun Wang
Professor in Department of Maternal and Child Health, School of Public Health, Peking University
Peking University