Childhood ObesityNCT05482165
Optimizing Intervention Effects in Children and Adolescents
A study testing Multi-faceted health promotion programme in people with Childhood 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
- Childhood Obesity
- What is being tested?
- Multi-faceted health promotion programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,627 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 to 10 years old.
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: Optimizing Intervention Effects in Children and Adolescents 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. Effective strategies to reduce childhood obesity prevalence may help to prevent related chronic diseases in the whole population in the long term.
This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in preventing childhood overweight and obesity; (2) to determine the sustainability of the intervention in preventing overweight and obesity; and (3) to evaluate the process and health economics of the intervention.
The project will be carried out in six primary schools in Ningbo City, Zhejiang Province , those schools are randomly divided into two groups: the intervention group and the usual practice group. The participants of the study were students in the third grade of primary school, and the intervention will last for one academic year. This intervention programme will target the influencing factors of childhood obesity at both individual (student-focused activities) and environmental levels (a supportive family and school environment), with the intent to influence the knowledge, attitude and behaviours of school children.
- Conditions
- Childhood Obesity
- Being tested
- Multi-faceted health promotion programme
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-faceted health promotion programmeBehavioural
This intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the intervention 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The students of this group will receive multi-faceted intervention activities toward weight management. Receives: Behavioral: Multi-faceted health promotion programme |
| Usual practice group | No intervention | The students of this group will receive regular health education. |
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: 9months , 24 months and 36 months
Secondary outcomes (8)
change in BMI z- score
- measures of relative weight adjusted for child age and sex
- caculated by terminal value minus baseline value
Measured: 9months , 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: 9 months
change in waist circumference
caculated by terminal value minus baseline value
Measured: 9 months, 24 months and 36 months
change in weight
caculated by terminal value minus baseline value
Measured: 9months, 24 months and 36 months
change in cardiorespiratory endurance test
caculated by terminal value minus baseline value
Measured: 9 months, 24 months and 36 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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,627 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
- NCT05482165
- Sponsor's protocol ID
- 2021-R168
- 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
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
- Optimizing Intervention Effects in Children and Adolescents in Ningbo City
- ClinicalTrials.gov ID
- NCT05482165
- Acronym / sponsor ID
- 2021-R168
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,627 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. Effective strategies to reduce childhood obesity prevalence may help to prevent related chronic diseases in the whole population in the long term.
This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in preventing childhood overweight and obesity; (2) to determine the sustainability of the intervention in preventing overweight and obesity; and (3) to evaluate the process and health economics of the intervention.
The project will be carried out in six primary schools in Ningbo City, Zhejiang Province , those schools are randomly divided into two groups: the intervention group and the usual practice group. The participants of the study were students in the third grade of primary school, and the intervention will last for one academic year. This intervention programme will target the influencing factors of childhood obesity at both individual (student-focused activities) and environmental levels (a supportive family and school environment), with the intent to influence the knowledge, attitude and behaviours of school children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Multi-faceted health promotion programmeThe students of this group will receive multi-faceted intervention activities toward weight management. |
| Usual practice group | No intervention | –The students of this group will receive regular health education. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents agree and support their children's weight loss, and students and parents have informed consent;
- Students in third grade aged 8 to 10 years old.
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 |
|---|---|---|
| Multi-faceted health promotion programmeThis intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the intervention 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 | Behavioural | Intervention group |
Primary outcome
change in body mass index (BMI）
Time frame: 9months , 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
8 secondary outcomes
change in BMI z- score
Time frame: 9months , 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: 9 months
change in waist circumference
Time frame: 9 months, 24 months and 36 months
change in weight
Time frame: 9months, 24 months and 36 months
change in cardiorespiratory endurance test
Time frame: 9 months, 24 months and 36 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.
- 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 Multi-faceted health promotion programme in people with Childhood 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 2 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: 9months , 24 months and 36 months). 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 9 Jul 2025.