Childhood ObesityNCT07126210
Weight Management Program for Obese Preschool Children
A study testing Family engaged, enhanced Diet intervention in people with Childhood Obesity, run by Peking University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Family engaged, enhanced Diet intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Maternal and Child Health, School of Public Health
Beijing, Beijing Municipality, 100191
About this study
Official title: Peking University-Family Engaged, Enhanced Diet, for Kids (PKU-FeeD)
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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Family engaged, enhanced Diet intervention
- Keywords
- Obesity, Intervention, Preschool, Management, Children
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family engaged, enhanced Diet interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| multicomponent intervention | Experimental | 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. Receives: Behavioral: Family engaged, enhanced Diet intervention |
| usual-care control | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at end of the 9-month intervention
Secondary outcomes (13)
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.
Measured: at 21-month follow-up.
Body Mass Index (BMI)
BMI is calculated from measured height and weight.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: at the end of the 9-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Oct 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Why it stopped: Study terminated prematurely due to poor accrual. The actual number of eligible children recruited from kindergartens was far lower than expected, making the study unfeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Maternal and Child Health Care Hospital
- Responsible party
- Principal investigator, Hai-Jun Wang, Peking University
- Investigators
- Haijun Wang, PhD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126210
- Sponsor's protocol ID
- IRB00001052-25071
- Status last verified
- Sep 2026
- First submitted
- 1 Aug 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking University-Family Engaged, Enhanced Diet, for Kids (PKU-FeeD)
- ClinicalTrials.gov ID
- NCT07126210
- Acronym / sponsor ID
- IRB00001052-25071
- Conditions
- Childhood Obesity
- Keywords
- Obesity, Intervention, Preschool, Management, Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely due to poor accrual. The actual number of eligible children recruited from kindergartens was far lower than expected, making the study unfeasible.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Maternal and Child Health Care Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multicomponent intervention | Experimental | Behavioral: Family engaged, enhanced Diet interventionThis 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. |
| usual-care control | No 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family engaged, enhanced Diet interventionThe 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. | Behavioural | multicomponent intervention |
Primary outcome
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.
13 secondary outcomes
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
Gut Microbial Composition
Time frame: at the end of the 9-month intervention
Results and safety
The study was stopped early (reason given: Study terminated prematurely due to poor accrual. The actual number of eligible children recruited from kindergartens was far lower than expected, making the study unfeasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haijun Wang, PhD principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family engaged, enhanced Diet intervention in people with Childhood Obesity, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated prematurely due to poor accrual. The actual number of eligible children recruited from kindergartens was far lower than expected, making the study unfeasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
children's BMI-Z change (time frame: at end of the 9-month intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.