跳至主要内容
临床试验/NCT06489990
NCT06489990尚未招募不适用

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 University1 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
440
试验地点
1
主要终点
Patient Health Questionnaire-9(PHQ-9)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.
  • 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.

排除标准

  • 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.
  • 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.

结局指标

主要结局

Patient Health Questionnaire-9(PHQ-9)

时间窗: 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

次要结局

  • BMI(From enrollment to the end of treatment at baseline、12 weeks、6months)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Linghui Meng

Director of Department of Clinical Research Methodology,Beijing Anding Hospital, Capital Medical University

Capital Medical University

研究点 (1)

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