Overweight and ObesityNCT06562465
Prevention and Intervention of Overweight and Obesity in Preschool Children
A study testing dietary and exercise management and no dietary and exercise management in people with Overweight and Obesity, run by Chen Li at 2 sites in China.
Trial summary
Obesity is an important public health problem, which is directly related to the risk of childhood complications and the increase of incidence rate and mortality of adult complications. The consequences are more serious than malnutrition such as low weight. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- dietary and exercise management and no dietary and exercise management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2024to 30 Sep 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- overweight or obese Children Currently, there are no projects related to overweight and obesity management (such as weight loss management, etc.) Parents and children are willing to accept dietary and exercise management for a period of 4 months Willing to measure height, weight, BMI, blood pressure, body composition, questionnaire survey (exercise, diet, etc.) and other items before intervention and 1 month, 2 months, 3 months, and 4 months after intervention (a total of 5 times) Willing to undergo blood tests before and 4 months after intervention (2 times in total); The questionnaire information is filled in accurately and meets the questionnaire quality control standards
Who cannot join
- Recruiter exclusion criteria:
- Preschool children with underlying diseases (such as congenital heart disease, liver and kidney disease, thyroid disease, malignant tumors, etc.) or uncontrolled underlying diseases
- Questionnaire exclusion criteria:
- Incorrect information filling in the questionnaire, which does not meet the questionnaire quality control standards
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Growth,Development and Mental Health of Children and Adolescents Center
Chongqing, Chongqing Municipality, 400014
Li Chen, MD, (+86)13677620103 ext. +86, chenli2012@126.com
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing
Li Chen, 136 7762 0103 ext. 86, chenli2012@126.com
Jinwei Tu, 17830831834 ext. 86, 1522753518@qq.com
About this study
Official title: Research on Prevention and Intervention of Overweight and Obesity in Preschool Children
Obesity is an important public health problem, which is directly related to the risk of childhood complications and the increase of incidence rate and mortality of adult complications. The consequences are more serious than malnutrition such as low weight. Since the 1980s, the obesity rate among children in China has gradually increased. Currently, overweight and obesity are important health issues for children in rural and urban areas of China, with obesity rates in many large cities approaching or exceeding those in developed countries. The Report on Nutrition and Chronic Disease Status of Chinese Residents (2020) shows that the overweight and obesity rate among children aged 6-17 in China has approached 20%, with 10% of children under 6 years old. The imbalance between energy intake and expenditure is the direct cause of individual overweight and obesity. The 2021 "Healthy Children Action Plan (2021-2025)" explicitly requires the implementation of early screening, early diagnosis, and early treatment prevention and control strategies for risk factors such as obesity that seriously endanger children's health, reducing disease burden, promoting children's health, emphasizing the principle of prevention first and combining prevention and treatment. Given the current status of children's nutrition and health in China, it is an urgent need to establish a standardized and regulated monitoring and management system for obesity and overweight in preschool children, as well as service standards, for the development of children's health. This project aims to establish a complete prevention, improvement, and intervention promotion plan for obesity and overweight in preschool children, as well as a comprehensive monitoring and management system that combines medicine, education, home, and community. It will strengthen children's nutrition feeding and exercise guidance, reduce sedentary time, promote food and movement balance, and prevent and reduce childhood overweight and obesity. Provide children with comprehensive, full process, and warm children's healthcare clothing, and provide small-scale policy research references for the implementation of support systems for children's nutrition improvement projects.
Read the detailed description
- Procedures. Step 1: Epidemiological survey: Conduct a health survey on preschool children in selected kindergartens to understand the prevalence and risk factors of overweight and obese children; Phase 2: Recruit overweight and obese children from kindergartens with a population of over 200 in Chongqing, and randomly divide them into an intervention group and a blank control group. Dietary and exercise management, combined with reward and support mechanism monitoring, were implemented for the intervention group, while the blank control group did not receive the aforementioned interventions. Measure the height, weight, BMI, questionnaire survey, blood indicators, etc. of the children before and after the intervention, and use them as evaluation indicators.
- The sample size for comparing the means of the two groups is N=(Z α/2+Z β) 2 σ 2 (Q1-1+Q2-1)/δ 2. If the difference in BMI decrease between the two groups after intervention is 0.58, and if σ=1.2 and α is taken as 0.05 on both sides, the test power is 0.8, Q1=Q2=0.5，σ=1.2，δ=0.58，Z0.05/2=1.96，Zβ=0.842， Calculate N=(1.96+0.842) 2 * 1.22 * (0.5-1+0.5-1)/0.582 ≈ 69, taking into account the situation of loss to follow-up and refusal to follow up at 20%. The final required two groups of research subjects are 87, and a total of at least 174 research subjects will be included.
- Statistical analysis. SPSS 26.0 software was used for statistical analysis, and descriptive statistics were performed on general demographic data. Count data was expressed as n (%), and inter group comparisons of rates were performed using a 2-test. Continuous variables that followed a normal distribution were described as mean ± standard deviation (x ± s), and inter group comparisons were performed using t-test. All tests were two-sided, and the test level α was set to 0.05. Multivariate logistic regression analysis of the correlation between nutritional status and risk factors. Using rank sum test to compare the differences in various indicators before and after intervention in obese and overweight children.
5.Ethical matters and data protection. The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
- Conditions
- Overweight and Obesity
- Being tested
- dietary and exercise management, no dietary and exercise management
- Keywords
- Diet management, sports management, overweight, obesity, preschool children
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary and exercise managementProcedure or surgery
Dietary and exercise management: dietary management by providing tailored recipes, health education lectures, science competitions, etc；exercise management:develop weekly and monthly exercise plans for children of different ages, and have physical education teachers lead them in exercising.
no dietary and exercise managementProcedure or surgery
NO dietary and exercise management:do not implement dietary and exercise management related to the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The overweight and obese children aged 3-6 years old,receive dietary and exercise management, combined reward support mechanisms. Receives: Procedure: dietary and exercise management |
| Control group | Active comparator | The overweight and obese children aged 3-6 years old only receive basic health guidance,do not receive dietary and exercise management nor combined reward support mechanisms like experimental group. Receives: Procedure: no dietary and exercise management |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Changes in BMI between the experimental group and intervention group at the beginning and end of the project
Measured: 3-4 months
Secondary outcomes (3)
Body composition--Fat (%)
Changes in Body composition including Fat (%) between the experimental group and intervention group at the beginning and end of the project.
Measured: 3-4 months
Body composition--Body fat index (BFMI)
Changes in Body composition including Body fat index (BFMI) between the experimental group and intervention group at the beginning and end of the project.
Measured: 3-4 months
Body composition--Fat-free mass index (FFMI)
Changes in Body composition including Fat-free mass index (FFMI) between the experimental group and intervention group at the beginning and end of the project.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Mar 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruit at least 174 overweight and obese children from kindergartens with a population of 200 or more in Chongqing, and recruit them in the order of screening and informed consent until they are fully recruited. Divided into intervention group and blank control group based on kindergarten.
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Li
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, China Soong Ching Ling Foundation
- Responsible party
- Sponsor-investigator, Chen Li, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562465
- Sponsor's protocol ID
- OABIPC
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is confidential during the study.
Publications
Dong YH, Chen L, Liu JY, Ma T, Zhang Y, Chen MM, Zhong PL, Shi D, Hu PJ, Li J, Dong B, Song Y, Ma J. [Epidemiology and prediction of overweight and obesity among children and adolescents aged 7-18 years in China from 1985 to 2019]. Zhonghua Yu Fang Yi Xue Za Zhi. 2023 Feb 28;57:11-19. doi: 10.3760/cma.j.cn112150-20220906-00881. Online ahead of print. Chinese.
PubMed 36854438Lister NB, Baur LA, Felix JF, Hill AJ, Marcus C, Reinehr T, Summerbell C, Wabitsch M. Child and adolescent obesity. Nat Rev Dis Primers. 2023 May 18;9(1):24. doi: 10.1038/s41572-023-00435-4.
PubMed 37202378Hughes AR, Sherriff A, Ness AR, Reilly JJ. Timing of adiposity rebound and adiposity in adolescence. Pediatrics. 2014 Nov;134(5):e1354-61. doi: 10.1542/peds.2014-1908. Epub 2014 Oct 13.
PubMed 25311600Brown T, Moore TH, Hooper L, Gao Y, Zayegh A, Ijaz S, Elwenspoek M, Foxen SC, Magee L, O'Malley C, Waters E, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2019 Jul 23;7(7):CD001871. doi: 10.1002/14651858.CD001871.pub4.
PubMed 31332776
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Prevention and Intervention of Overweight and Obesity in Preschool Children
- ClinicalTrials.gov ID
- NCT06562465
- Acronym / sponsor ID
- OABIPC
- Conditions
- Overweight and Obesity
- Keywords
- Diet management, sports management, overweight, obesity, preschool children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Chen LiUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, China Soong Ching Ling Foundation
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Aug 2024 (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.
Obesity is an important public health problem, which is directly related to the risk of childhood complications and the increase of incidence rate and mortality of adult complications. The consequences are more serious than malnutrition such as low weight. Since the 1980s, the obesity rate among children in China has gradually increased. Currently, overweight and obesity are important health issues for children in rural and urban areas of China, with obesity rates in many large cities approaching or exceeding those in developed countries. The Report on Nutrition and Chronic Disease Status of Chinese Residents (2020) shows that the overweight and obesity rate among children aged 6-17 in China has approached 20%, with 10% of children under 6 years old. The imbalance between energy intake and expenditure is the direct cause of individual overweight and obesity. The 2021 "Healthy Children Action Plan (2021-2025)" explicitly requires the implementation of early screening, early diagnosis, and early treatment prevention and control strategies for risk factors such as obesity that seriously endanger children's health, reducing disease burden, promoting children's health, emphasizing the principle of prevention first and combining prevention and treatment. Given the current status of children's nutrition and health in China, it is an urgent need to establish a standardized and regulated monitoring and management system for obesity and overweight in preschool children, as well as service standards, for the development of children's health. This project aims to establish a complete prevention, improvement, and intervention promotion plan for obesity and overweight in preschool children, as well as a comprehensive monitoring and management system that combines medicine, education, home, and community. It will strengthen children's nutrition feeding and exercise guidance, reduce sedentary time, promote food and movement balance, and prevent and reduce childhood overweight and obesity. Provide children with comprehensive, full process, and warm children's healthcare clothing, and provide small-scale policy research references for the implementation of support systems for children's nutrition improvement projects.
Detailed description
- Procedures. Step 1: Epidemiological survey: Conduct a health survey on preschool children in selected kindergartens to understand the prevalence and risk factors of overweight and obese children; Phase 2: Recruit overweight and obese children from kindergartens with a population of over 200 in Chongqing, and randomly divide them into an intervention group and a blank control group. Dietary and exercise management, combined with reward and support mechanism monitoring, were implemented for the intervention group, while the blank control group did not receive the aforementioned interventions. Measure the height, weight, BMI, questionnaire survey, blood indicators, etc. of the children before and after the intervention, and use them as evaluation indicators.
- The sample size for comparing the means of the two groups is N=(Z α/2+Z β) 2 σ 2 (Q1-1+Q2-1)/δ 2. If the difference in BMI decrease between the two groups after intervention is 0.58, and if σ=1.2 and α is taken as 0.05 on both sides, the test power is 0.8, Q1=Q2=0.5，σ=1.2，δ=0.58，Z0.05/2=1.96，Zβ=0.842， Calculate N=(1.96+0.842) 2 * 1.22 * (0.5-1+0.5-1)/0.582 ≈ 69, taking into account the situation of loss to follow-up and refusal to follow up at 20%. The final required two groups of research subjects are 87, and a total of at least 174 research subjects will be included.
- Statistical analysis. SPSS 26.0 software was used for statistical analysis, and descriptive statistics were performed on general demographic data. Count data was expressed as n (%), and inter group comparisons of rates were performed using a 2-test. Continuous variables that followed a normal distribution were described as mean ± standard deviation (x ± s), and inter group comparisons were performed using t-test. All tests were two-sided, and the test level α was set to 0.05. Multivariate logistic regression analysis of the correlation between nutritional status and risk factors. Using rank sum test to compare the differences in various indicators before and after intervention in obese and overweight children.
5.Ethical matters and data protection. The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Recruit at least 174 overweight and obese children from kindergartens with a population of 200 or more in Chongqing, and recruit them in the order of screening and informed consent until they are fully recruited. Divided into intervention group and blank control group based on kindergarten.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: dietary and exercise managementThe overweight and obese children aged 3-6 years old,receive dietary and exercise management, combined reward support mechanisms. |
| Control group | Active comparator | Procedure: no dietary and exercise managementThe overweight and obese children aged 3-6 years old only receive basic health guidance,do not receive dietary and exercise management nor combined reward support mechanisms like experimental group. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- overweight or obese Children Currently, there are no projects related to overweight and obesity management (such as weight loss management, etc.) Parents and children are willing to accept dietary and exercise management for a period of 4 months Willing to measure height, weight, BMI, blood pressure, body composition, questionnaire survey (exercise, diet, etc.) and other items before intervention and 1 month, 2 months, 3 months, and 4 months after intervention (a total of 5 times) Willing to undergo blood tests before and 4 months after intervention (2 times in total); The questionnaire information is filled in accurately and meets the questionnaire quality control standards
Key exclusion criteria (4 listed)
- Preschool children with underlying diseases (such as congenital heart disease, liver and kidney disease, thyroid disease, malignant tumors, etc.) or uncontrolled underlying diseases
- Incorrect information filling in the questionnaire, which does not meet the questionnaire quality control standards
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 |
|---|---|---|
| dietary and exercise managementDietary and exercise management: dietary management by providing tailored recipes, health education lectures, science competitions, etc；exercise management:develop weekly and monthly exercise plans for children of different ages, and have physical education teachers lead them in exercising. | Procedure or surgery | Experimental group |
| no dietary and exercise managementNO dietary and exercise management:do not implement dietary and exercise management related to the experimental group | Procedure or surgery | Control group |
Primary outcome
BMI
Time frame: 3-4 months
Changes in BMI between the experimental group and intervention group at the beginning and end of the project
3 secondary outcomes
Body composition--Fat (%)
Time frame: 3-4 months
Body composition--Body fat index (BFMI)
Time frame: 3-4 months
Body composition--Fat-free mass index (FFMI)
Time frame: 3-4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 36854438Dong YH, Chen L, Liu JY, Ma T, Zhang Y, Chen MM, Zhong PL, Shi D, Hu PJ, Li J, Dong B, Song Y, Ma J. [Epidemiology and prediction of overweight and obesity among children and adolescents aged 7-18 years in China from 1985 to 2019]. Zhonghua Yu Fang Yi Xue Za Zhi. 2023 Feb 28;57:11-19. doi: 10.3760/cma.j.cn112150-20220906-00881. Online ahead of print. Chinese.
- Background: PubMed 37202378Lister NB, Baur LA, Felix JF, Hill AJ, Marcus C, Reinehr T, Summerbell C, Wabitsch M. Child and adolescent obesity. Nat Rev Dis Primers. 2023 May 18;9(1):24. doi: 10.1038/s41572-023-00435-4.
- Results publication: PubMed 25311600Hughes AR, Sherriff A, Ness AR, Reilly JJ. Timing of adiposity rebound and adiposity in adolescence. Pediatrics. 2014 Nov;134(5):e1354-61. doi: 10.1542/peds.2014-1908. Epub 2014 Oct 13.
- Results publication: PubMed 31332776Brown T, Moore TH, Hooper L, Gao Y, Zayegh A, Ijaz S, Elwenspoek M, Foxen SC, Magee L, O'Malley C, Waters E, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2019 Jul 23;7(7):CD001871. doi: 10.1002/14651858.CD001871.pub4.
- Individual participant dataSharing planned: No. Data is confidential during the study.
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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.
Growth,Development and Mental Health of Children and Adolescents Center
Chongqing, China
Children's Hospital of Chongqing Medical University
Chongqing, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary and exercise management and no dietary and exercise management in people with Overweight and Obesity, run by Chen Li at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 3-4 months). 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 NCT06562465, which also lists 4 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 20 Aug 2024.