DepressionNCT06489990
Implementation Research on the Intervention Mode of " Comorbidity-Co-causes-Joint-prevention" Comprehensive Demonstration District of Depression and Obesity Among Children and Adolescents in Beijing
A study testing combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention] and routine health education and mental health knowledge in people with Depression and Obesity, run by Capital Medical University at 1 site in China.
Trial summary
Depression and obesity have become the most prominent health problems among adolescents and have caused a heavy burden on the health and social economy of the whole population. There are high incidence, comorbidity and co-pathogenic factors of depression and obesity in adolescents, but there is still a lack of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression, Obesity, High Risk of Depression
- What is being tested?
- combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention] and routine health education and mental health knowledge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage I (screening stage):
- Middle school students in Beijing Economic-Technological Development Area and other districts of Beijing, both male and female;
- Students themselves and their guardians are willing to participate in this study and sign written informed consent file.
- Stage Ⅱ:
- Middle school students who were identified as high risk of depression and/or obesity in Stage I in Beijing Economic-Technological Development Area and other districts of Beijing, the screening criteria are as follows:
- ① CES-DC score ≥16 points;
- ② BMI ≥WS/T586-2018: Screened as overweight and obesity among school-age children and adolescents, according to the recommendation by the National Health Commission;
- ③ Students themselves and their guardians are willing to participate in this study and provide written informed consent.
Who cannot join
- Stage I:
- Having serious physical or genetic disease that is not suitable for participation in the study;
- Have been evaluated that not suitable for this study by investigators.
- Stage Ⅱ:
- Having serious physical or genetic disease that is not suitable for participation in the study;
- Have been evaluated that not suitable for this study by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, 100088
About this study
Depression and obesity have become the most prominent health problems among adolescents and have caused a heavy burden on the health and social economy of the whole population. There are high incidence, comorbidity and co-pathogenic factors of depression and obesity in adolescents, but there is still a lack of research on joint prevention strategies and multi-sectoral collaborative prevention and control network. This project plans to screen and integrate effective intervention measures based on multi-stage optimization strategy, developing an intervention mode of [Comorbidity-Co-causes-Joint-prevention] for adolescents with depression or/and obesity, and then carry out with children or adolescents in Beijing based on digital platform. The investigators will be considering the accessibility, sustainability and replicability of the implement based on the RE-AIM framework including the coverage of population and organizations as well as the effect, implement and sustainability of the interventions. The research will be promoted with the help of the National Clinical Research Center for Mental Disorders and Monitoring of Student Common Diseases and Health Influencing Factors. The results of the research will establish an intervention mode of [Comorbidity-Co-causes-Joint-prevention] and a promotion model for adolescents' depression and obesity in Beijing, providing support for the realization of Healthy China 2030 and Healthy Beijing 2030 Plans.
- Conditions
- Depression, Obesity, High Risk of Depression, Overweight
- Being tested
- combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention], routine health education and mental health knowledge
- Keywords
- children, adolescents, depression, obesity, effectiveness evaluation, intervention mode
- Medical subject headings
- Depression, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]Combination product
combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]
routine health education and mental health knowledgeCombination product
routine health education and mental health knowledge
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | the intervention is combination intervention strategy of " Comorbidity-Co-causes-Joint-prevention" Receives: Combination Product: combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention] |
| control group | Placebo comparator | receiving routine health education and mental health knowledge Receives: Combination Product: routine health education and mental health knowledge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9(PHQ-9)
The score ranges from 0 to 27, the higher scores mean more serious depression
Measured: From enrollment to the end of treatment at baseline、12weeks、6months
Secondary outcomes (1)
BMI
Measured: From enrollment to the end of treatment at baseline、12 weeks、6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Center for Disease Control and Prevention of Bejing Economic-Technoloogical Develeopment Area
- Responsible party
- Principal investigator, Linghui Meng, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489990
- Sponsor's protocol ID
- CFH2024-1G-2121
- Status last verified
- Jul 2024
- First submitted
- 12 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Gui P, Lin J, Zhao Y, Zhang X, Song Y, Meng L. Implementation research on the intervention mode of "Comorbidity-Co-causes-Joint-prevention" comprehensive demonstration district of depression and obesity among children and adolescents in Beijing: study protocol. BMC Public Health. 2025 Sep 30;25(1):3232. doi: 10.1186/s12889-025-24339-y.
PubMed 41029633
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Research on the Intervention Mode of " Comorbidity-Co-causes-Joint-prevention" Comprehensive Demonstration District of Depression and Obesity Among Children and Adolescents in Beijing
- ClinicalTrials.gov ID
- NCT06489990
- Acronym / sponsor ID
- CFH2024-1G-2121
- Conditions
- Depression, Obesity, High Risk of Depression, Overweight
- Keywords
- children, adolescents, depression, obesity, effectiveness evaluation, intervention mode
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Peking University, Center for Disease Control and Prevention of Bejing Economic-Technoloogical Develeopment Area
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jul 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.
Depression and obesity have become the most prominent health problems among adolescents and have caused a heavy burden on the health and social economy of the whole population. There are high incidence, comorbidity and co-pathogenic factors of depression and obesity in adolescents, but there is still a lack of research on joint prevention strategies and multi-sectoral collaborative prevention and control network. This project plans to screen and integrate effective intervention measures based on multi-stage optimization strategy, developing an intervention mode of [Comorbidity-Co-causes-Joint-prevention] for adolescents with depression or/and obesity, and then carry out with children or adolescents in Beijing based on digital platform. The investigators will be considering the accessibility, sustainability and replicability of the implement based on the RE-AIM framework including the coverage of population and organizations as well as the effect, implement and sustainability of the interventions. The research will be promoted with the help of the National Clinical Research Center for Mental Disorders and Monitoring of Student Common Diseases and Health Influencing Factors. The results of the research will establish an intervention mode of [Comorbidity-Co-causes-Joint-prevention] and a promotion model for adolescents' depression and obesity in Beijing, providing support for the realization of Healthy China 2030 and Healthy Beijing 2030 Plans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Combination Product: combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]the intervention is combination intervention strategy of " Comorbidity-Co-causes-Joint-prevention" |
| control group | Placebo comparator | Combination Product: routine health education and mental health knowledgereceiving routine health education and mental health knowledge |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Stage I (screening stage):
- Middle school students who were identified as high risk of depression and/or obesity in Stage I in Beijing Economic-Technological Development Area and other districts of Beijing, the screening criteria are as follows:
- ① CES-DC score ≥16 points;
- ② BMI ≥WS/T586-2018: Screened as overweight and obesity among school-age children and adolescents, according to the recommendation by the National Health Commission;
- ③ Students themselves and their guardians are willing to participate in this study and provide written informed consent.
Key exclusion criteria (6 listed)
- Stage I:
- Having serious physical or genetic disease that is not suitable for participation in the study;
- Have been evaluated that not suitable for this study by investigators.
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 |
|---|---|---|
| combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention] | Combination product | intervention group |
| routine health education and mental health knowledgeroutine health education and mental health knowledge | Combination product | control group |
Primary outcome
Patient Health Questionnaire-9(PHQ-9)
Time frame: From enrollment to the end of treatment at baseline、12weeks、6months
The score ranges from 0 to 27, the higher scores mean more serious depression
1 secondary outcome
BMI
Time frame: From enrollment to the end of treatment at baseline、12 weeks、6months
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 8 Jul 2024.
- Derived from this study: PubMed 41029633Wang X, Gui P, Lin J, Zhao Y, Zhang X, Song Y, Meng L. Implementation research on the intervention mode of "Comorbidity-Co-causes-Joint-prevention" comprehensive demonstration district of depression and obesity among children and adolescents in Beijing: study protocol. BMC Public Health. 2025 Sep 30;25(1):3232. doi: 10.1186/s12889-025-24339-y.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention] and routine health education and mental health knowledge in people with Depression and Obesity, run by Capital Medical 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 8 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: opening soon, as of the sponsor's last update on 8 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Contact Linghui Meng, PHD (86 18210344972, linghuimeng@mail.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9(PHQ-9) (time frame: From enrollment to the end of treatment at baseline、12weeks、6months). 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 NCT06489990, which also lists 1 linked publication.
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 8 Jul 2024.