Weight Management Program for Obese Preschool Children

Peking University25 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Childhood Obesity

Interventions

Family engaged, enhanced Diet interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Maternal and Child Health, School of Public Health

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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