ObesityNCT05482191
Healthy Weight Management Project for Overweight and Obesity Children
A study testing Lifestyle intervention in people with Obesity, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Childhood obesity is a significant public health concern worldwide. In China, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parents agree and support their children's weight loss, and students and parents have informed consent;
- students in third grade aged 8 and 10 years old;
- students with childhood overweight/obesity defined according to the criteria for Chinese children and adolescents.
Who cannot join
- medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis or nephritis;
- obesity caused by endocrine diseases or side effects of drugs;
- abnormal physical development like dwarfism or gigantism;
- physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg;
- inability to participate in school sport activities;
- a loss in weight by vomiting or taking drugs during the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Weight Management Project for Overweight and Obesity Children in Ningbo City
Childhood obesity is a significant public health concern worldwide. In China, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. Nonalcoholic fatty liver disease (NAFLD) is tightly associated with obesity, in China, the prevalence of NAFLD in obesity children is 40.0%，the main interventions for NAFLD are lifestyle interventions. Effective strategies to helping students lose weight and alleviate NAFLD through lifestyle interventions may help promote the physical and mental health of obese students.
This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in treating childhood overweight and obesity; (2) to determine the sustainability of the treatment in preventing overweight and obesity; (3) to help alleviate or reverse NAFLD in obesity children.
Children with overweight and obesity in six primary schools in Ningbo City, Zhejiang Province will be seleted and randomly divided into two groups: the treatment group and the usual practice group. The participants of the study were students in the third grade of primary school, and the treatment will last for one academic year. This treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.
- Conditions
- Obesity
- Being tested
- Lifestyle intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
This intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the treatment group will receive the following interventions:
- Develop and implement school policies related to weight loss
- Distribute health education materials on diet and exercise to students
- Carry out student health education courses
- Diet and exercise instruction by professional nutritionist using internet applet
- Take part in sports activities that are organized by the sports health teacher during school hours.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity. Receives: Behavioral: Lifestyle intervention |
| Usual practice group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body mass index (BMI)
- weight and height will be combined to report BMI in kg/m^2
- caculated by terminal value minus baseline value
Measured: 3 months，9 months , 24 months and 36 months
change in controlled attenuation parameters (CAP)
- CAP will be detected by Fibroscan
- caculated by terminal value minus baseline value
Measured: 3 months，9 months , 24 months and 36 months
Change in liver stiffness measurement (LSM)
- LSM will be detected by Fibroscan
- caculated by terminal value minus baseline value
Measured: 3 months，9 months , 24 months and 36 months
Secondary outcomes (9)
Change in BMI z- score
- BMI z- score are measures of relative weight adjusted for child age and sex
- caculated by terminal value minus baseline value
Measured: 3 months，9 months , 24 months and 36 months
change in blood glucose
caculated by terminal value minus baseline value
Measured: 9 months
change in blood lipids
- include TC, TG, LDL-C, HDL-C
- caculated by terminal value minus baseline value
Measured: 9 months
change in fasting insulin
caculated by terminal value minus baseline value
Measured: 9 months
change in body fat percentage
caculated by terminal value minus baseline value
Measured: 3 months and 9 months
change in waist circumference
caculated by terminal value minus baseline value
Measured: 3 months，9 months , 24 months and 36 months
change in weight
caculated by terminal value minus baseline value
Measured: 3 months，9 months , 24 months and 36 months
change in cardiorespiratory endurance test
caculated by terminal value minus baseline value
Measured: 3 months，9 months , 24 months and 36 months
change in ALT(alanine transaminase)
caculated by terminal value minus baseline value
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start1 Sep 2022
- Primary completion25 Jun 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482191
- Sponsor's protocol ID
- NBFH20220667
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2022
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang PP, Li L, Fu H, Nur E, Xu D, Wang Y, Gu J, Xu M, Zhou Y, Shen F, Li X, Xing Y, Jin S, Li J, Song Q, Li H, Wen LM, Wang H, Wang HJ. Effect of an mHealth-assisted multifaceted lifestyle intervention on body-mass index, hepatic fat content and stiffness in children with overweight or obesity: a cluster randomised controlled trial. EClinicalMedicine. 2026 Mar 21;94:103840. doi: 10.1016/j.eclinm.2026.103840. eCollection 2026 Apr.
PubMed 42077646Zhang PP, Wang YX, Shen FJ, Xing YF, Gu JY, Li XY, Jin H, Jin SF, Xu M, Wang HJ, Wang H, Li L. Lifestyle intervention in children with obesity and nonalcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled trial in Ningbo city (the SCIENT study). Trials. 2024 Mar 20;25(1):196. doi: 10.1186/s13063-024-08046-4.
PubMed 38504343
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Weight Management Project for Overweight and Obesity Children in Ningbo City
- ClinicalTrials.gov ID
- NCT05482191
- Acronym / sponsor ID
- NBFH20220667
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2022 (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.
Childhood obesity is a significant public health concern worldwide. In China, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. Nonalcoholic fatty liver disease (NAFLD) is tightly associated with obesity, in China, the prevalence of NAFLD in obesity children is 40.0%，the main interventions for NAFLD are lifestyle interventions. Effective strategies to helping students lose weight and alleviate NAFLD through lifestyle interventions may help promote the physical and mental health of obese students.
This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in treating childhood overweight and obesity; (2) to determine the sustainability of the treatment in preventing overweight and obesity; (3) to help alleviate or reverse NAFLD in obesity children.
Children with overweight and obesity in six primary schools in Ningbo City, Zhejiang Province will be seleted and randomly divided into two groups: the treatment group and the usual practice group. The participants of the study were students in the third grade of primary school, and the treatment will last for one academic year. This treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Lifestyle interventionTreatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity. |
| Usual practice group | No intervention | –No intervention |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- parents agree and support their children's weight loss, and students and parents have informed consent;
- students in third grade aged 8 and 10 years old;
- students with childhood overweight/obesity defined according to the criteria for Chinese children and adolescents.
Key exclusion criteria (6 listed)
- medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis or nephritis;
- obesity caused by endocrine diseases or side effects of drugs;
- abnormal physical development like dwarfism or gigantism;
- physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg;
- inability to participate in school sport activities;
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 |
|---|---|---|
| Lifestyle interventionThis intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the treatment group will receive the following interventions: * Develop and implement school policies related to weight loss * Distribute health education materials on diet and exercise to students * Carry out student health education courses * Diet and exercise instruction by professional nutritionist using internet applet * Take part in sports activities that are organized by the sports health teacher during school hours. | Behavioural | Treatment group |
Primary outcome
change in body mass index (BMI)
Time frame: 3 months，9 months , 24 months and 36 months
* weight and height will be combined to report BMI in kg/m^2 * caculated by terminal value minus baseline value
change in controlled attenuation parameters (CAP)
Time frame: 3 months，9 months , 24 months and 36 months
* CAP will be detected by Fibroscan * caculated by terminal value minus baseline value
Change in liver stiffness measurement (LSM)
Time frame: 3 months，9 months , 24 months and 36 months
* LSM will be detected by Fibroscan * caculated by terminal value minus baseline value
9 secondary outcomes
Change in BMI z- score
Time frame: 3 months，9 months , 24 months and 36 months
change in blood glucose
Time frame: 9 months
change in blood lipids
Time frame: 9 months
change in fasting insulin
Time frame: 9 months
change in body fat percentage
Time frame: 3 months and 9 months
change in waist circumference
Time frame: 3 months，9 months , 24 months and 36 months
change in weight
Time frame: 3 months，9 months , 24 months and 36 months
change in cardiorespiratory endurance test
Time frame: 3 months，9 months , 24 months and 36 months
change in ALT(alanine transaminase)
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 42077646Zhang PP, Li L, Fu H, Nur E, Xu D, Wang Y, Gu J, Xu M, Zhou Y, Shen F, Li X, Xing Y, Jin S, Li J, Song Q, Li H, Wen LM, Wang H, Wang HJ. Effect of an mHealth-assisted multifaceted lifestyle intervention on body-mass index, hepatic fat content and stiffness in children with overweight or obesity: a cluster randomised controlled trial. EClinicalMedicine. 2026 Mar 21;94:103840. doi: 10.1016/j.eclinm.2026.103840. eCollection 2026 Apr.
- Derived from this study: PubMed 38504343Zhang PP, Wang YX, Shen FJ, Xing YF, Gu JY, Li XY, Jin H, Jin SF, Xu M, Wang HJ, Wang H, Li L. Lifestyle intervention in children with obesity and nonalcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled trial in Ningbo city (the SCIENT study). Trials. 2024 Mar 20;25(1):196. doi: 10.1186/s13063-024-08046-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Obesity, run by Ningbo No. 1 Hospital 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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
change in body mass index (BMI) (time frame: 3 months，9 months , 24 months and 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05482191, which also lists 2 linked publications.
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 9 Jul 2025.