An interventional study of Family engaged, enhanced Diet intervention in Childhood Obesity, sponsored by Peking University. Terminated at 1 site in China. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Peking University · Not applicable, Interventional, and Treatment
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.
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's enrollment of 25 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.
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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.
Behavioral: Family engaged, enhanced Diet intervention
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.
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 counseling and facilitate clinic access as needed. The mobile health platform integrates modules for health education, smart growth curve tracking, behavior goal management, and home-school-hospital collaboration.
children's BMI-Z change
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.
Time frame: at end of the 9-month intervention
children's BMI-Z change
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 follow-up.
Time frame: at 21-month follow-up.
Body Mass Index (BMI)
BMI is calculated from measured height and weight.
Time frame: at the end of the 9-month intervention; at 21-month follow-up.
Waist Circumference
Waist circumference is measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest to evaluate central adiposity.
Time frame: at the end of the 9-month intervention; at 21-month follow-up
waist-to-Height Ratio, WHtR
Calculated by dividing waist circumference by height, used as an indicator of fat distribution and risk for metabolic complications.
Time frame: at the end of the 9-month intervention; at 21-month follow-up.
Systolic and Diastolic Blood Pressures
Blood pressure is measured using an electronic sphygmomanometer with the child seated after resting, to assess cardiovascular health.
Time frame: at the end of the 9-month intervention; at 21-month follow-up.
Body Composition
Body fat percentage is assessed using a bioelectrical impedance analyzer (MC-780A, TANITA, Tokyo, Japan).
Time frame: at the end of the 9-month intervention
Prevalence and Incidence of Overweight/Obesity
The proportion of children classified as overweight or obese according to WHO and Chinese standards, including newly identified cases at follow-up.
Time frame: at the end of the 9-month intervention; at 21-month follow-up
Dietary Intake
Total energy intake, macronutrient distribution, and food group consumption will be assessed using three consecutive 24-hour dietary recalls. Changes in dietary quality and structure will be evaluated.
Time frame: at the end of the 9-month intervention
Children's Eating Behaviors
Assessed using the Children's Eating Behavior Questionnaire (CEBQ), measuring dimensions such as food responsiveness, satiety responsiveness, and emotional eating
Time frame: at the end of the 9-month intervention
Parental Feeding Practices (CPCFBS)
Measured using the Chinese Preschooler's Caregivers Feeding Behavior Scale (CPCFBS), evaluating dimensions such as monitoring, pressure to eat, and food restriction.
Time frame: at the end of the 9-month intervention
Time Spent in Physical Activity
1)Children will wear an ActiGraph accelerometer for 7 consecutive days. Time spent in light, moderate, and vigorous physical activity will be calculated to evaluate changes in physical activity patterns. 2) Evaluated using the Children's Leisure Activities Study Survey (CLASS), assessing the amount and type of physical activity and sedentary behavior, including screen time.
Time frame: at the end of the 9-month intervention
Sedentary Behavior and Screen Time
1)Children will wear an ActiGraph accelerometer for 7 consecutive days. Time spent in light, moderate, and vigorous physical activity will be calculated to evaluate changes in physical activity patterns. 2) Evaluated using the Children's Leisure Activities Study Survey (CLASS), assessing the amount and type of physical activity and sedentary behavior, including screen time.
Time frame: at the end of the 9-month intervention
Gut Microbial Composition
Stool samples will be collected at baseline and post-intervention. Gut microbial composition is measured by 16S rRNA sequencing
Time frame: at the end of the 9-month intervention
Plan to share: No — Individual participant data (IPD) will not be shared publicly due to ethical considerations. In accordance with the study's ethical approval and informed consent procedures, the data contain potentially sensitive personal health information and are protected to ensure participant confidentiality and privacy. Data access is therefore restricted to authorized research personnel only and cannot be made publicly available.
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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