Weight Management Program for Obese Preschool Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Family engaged, enhanced Diet intervention.
- Who it may be relevant to
- Registry conditions: Childhood Obesity. Basic parameters: 4 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Peking University-Family Engaged, Enhanced Diet, for Kids (PKU-FeeD)
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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
Primary outcome measures
- children's BMI-Z change [Time frame: at end of the 9-month intervention]
Secondary outcome measures (12)
- children's BMI-Z change [Time frame: at 21-month follow-up.]
- Body Mass Index (BMI) [Time frame: at the end of the 9-month intervention; at 21-month follow-up.]
- Waist Circumference [Time frame: at the end of the 9-month intervention; at 21-month follow-up]
- waist-to-Height Ratio, WHtR [Time frame: at the end of the 9-month intervention; at 21-month follow-up.]
- Systolic and Diastolic Blood Pressures [Time frame: at the end of the 9-month intervention; at 21-month follow-up.]
- Body Composition [Time frame: at the end of the 9-month intervention]
- Prevalence and Incidence of Overweight/Obesity [Time frame: at the end of the 9-month intervention; at 21-month follow-up]
- Dietary Intake [Time frame: at the end of the 9-month intervention]
- Children's Eating Behaviors [Time frame: at the end of the 9-month intervention]
- Parental Feeding Practices (CPCFBS) [Time frame: at the end of the 9-month intervention]
- Time Spent in Physical Activity [Time frame: at the end of the 9-month intervention]
- Sedentary Behavior and Screen Time [Time frame: at the end of the 9-month intervention]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Maternal and Child Health, School of Public Health — Beijing
Identifiers
NCT: NCT07126210 · IRB00001052-25071