Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Obesity
High Risk of Depression
Overweight
Keywords: children
adolescents
depression
obesity
effectiveness evaluation
intervention mode
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Peking University
name: Center for Disease Control and Prevention of Bejing Economic-Technoloogical Develeopment Area
First posted: 2024-07-08
Enrollment: 440
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility 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.

Primary outcomes:
measure: Patient Health Questionnaire-9(PHQ-9)
timeFrame: From enrollment to the end of treatment at baseline、12weeks、6months
Secondary outcomes:
measure: BMI
timeFrame: From enrollment to the end of treatment at baseline、12 weeks、6months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital, Capital Medical University
state: Beijing
Study officials:
References: