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Not yet recruiting NCT06489990

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

No phase Interventional Depression Obesity High Risk of Depression Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention], routine health education and mental health knowledge.
Who it may be relevant to
Registry conditions: Depression, Obesity, High Risk of Depression, Overweight. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Combination product combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]
    combination intervention strategy of \[Comorbidity-Co-causes-Joint-prevention\]
  • Combination product routine health education and mental health knowledge
    routine health education and mental health knowledge

Primary outcome measures

  • Patient Health Questionnaire-9(PHQ-9) [Time frame: From enrollment to the end of treatment at baseline、12weeks、6months]
Secondary outcome measures (1)
  • BMI [Time frame: From enrollment to the end of treatment at baseline、12 weeks、6months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Beijing Anding Hospital, Capital Medical University — Beijing

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. PMID 41029633

Identifiers

NCT: NCT06489990 · CFH2024-1G-2121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗