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NCT Number: NCT07126210

Weight Management Program for Obese Preschool Children

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Maternal and Child Health, School of Public Health

Beijing, Beijing Municipality, 100191, China

Location contact

Shiyu Yan, PhD

CONTACT

[email protected]

+8618888923314

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family engaged, enhanced Diet intervention

Behavioral

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.

Primary outcomes

  1. children's BMI-Z change

    Time frame: 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.

Secondary outcomes

  1. children's BMI-Z change

    Time frame: at 21-month follow-up.

    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.

  2. Body Mass Index (BMI)

    Time frame: at the end of the 9-month intervention; at 21-month follow-up.

    BMI is calculated from measured height and weight.

  3. Waist Circumference

    Time frame: at the end of the 9-month intervention; at 21-month follow-up

    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.

  4. waist-to-Height Ratio, WHtR

    Time frame: at the end of the 9-month intervention; at 21-month follow-up.

    Calculated by dividing waist circumference by height, used as an indicator of fat distribution and risk for metabolic complications.

  5. Systolic and Diastolic Blood Pressures

    Time frame: at the end of the 9-month intervention; at 21-month follow-up.

    Blood pressure is measured using an electronic sphygmomanometer with the child seated after resting, to assess cardiovascular health.

  6. Body Composition

    Time frame: at the end of the 9-month intervention

    Body fat percentage is assessed using a bioelectrical impedance analyzer (MC-780A, TANITA, Tokyo, Japan).

  7. Prevalence and Incidence of Overweight/Obesity

    Time frame: at the end of the 9-month intervention; at 21-month follow-up

    The proportion of children classified as overweight or obese according to WHO and Chinese standards, including newly identified cases at follow-up.

  8. Dietary Intake

    Time frame: at the end of the 9-month intervention

    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.

  9. Children's Eating Behaviors

    Time frame: at the end of the 9-month intervention

    Assessed using the Children's Eating Behavior Questionnaire (CEBQ), measuring dimensions such as food responsiveness, satiety responsiveness, and emotional eating

  10. Parental Feeding Practices (CPCFBS)

    Time frame: at the end of the 9-month intervention

    Measured using the Chinese Preschooler's Caregivers Feeding Behavior Scale (CPCFBS), evaluating dimensions such as monitoring, pressure to eat, and food restriction.

  11. Time Spent in Physical Activity

    Time frame: at the end of the 9-month intervention

    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.

  12. Sedentary Behavior and Screen Time

    Time frame: at the end of the 9-month intervention

    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.

  13. Gut Microbial Composition

    Time frame: at the end of the 9-month intervention

    Stool samples will be collected at baseline and post-intervention. Gut microbial composition is measured by 16S rRNA sequencing

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyu Yan, PhD

CONTACT

[email protected]

+8618888923314

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Shandong Maternal and Child Health Hospital

Registry information

Official study title

Peking University-Family Engaged, Enhanced Diet, for Kids (PKU-FeeD)

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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