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

Capital Medical University

Status: Not yet enrolling

Conditions: Overweight; High Risk of Depression; Obesity; Depression

Treatments: Combination Product: combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]; Combination Product: routine health education and mental health knowledge

Study type: Interventional

Funder types: Other

Identifiers

NCT06489990

CFH2024-1G-2121

Details and patient eligibility

About

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.

Enrollment: 440 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Stage I (screening stage):

  1. Middle school students in Beijing Economic-Technological Development Area and other districts of Beijing, both male and female;

  2. 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:

  1. Having serious physical or genetic disease that is not suitable for participation in the study;
  2. Have been evaluated that not suitable for this study by investigators.

Stage Ⅱ:

1. Having serious physical or genetic disease that is not suitable for participation in the study;
2. Have been evaluated that not suitable for this study by investigators.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups, including a placebo group

intervention group

Active Comparator group

Description:

the intervention is combination intervention strategy of " Comorbidity-Co-causes-Joint-prevention"

Treatment:

Combination Product: combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]

control group

Placebo Comparator group

Description:

receiving routine health education and mental health knowledge

Treatment:

Combination Product: routine health education and mental health knowledge