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

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 Overview

• Status: Not yet recruiting
• Conditions: Depression; Obesity; Overweight; High Risk of Depression
• Intervention / Treatment: Combination product: combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]; Combination product: routine health education and mental health knowledge

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linghui Meng, PHD; Phone Number: 86 18210344972; Email: linghuimeng@mail.ccmu.edu.cn
• Study Contact Backup: Name: Pingping Gui; Phone Number: 86 13253610521; Email: guipingping2022@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100088
      • Beijing Anding Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention group; the intervention is combination intervention strategy of " Comorbidity-Co-causes-Joint-prevention"	Combination product: combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]; combination intervention strategy of [Comorbidity-Co-causes-Joint-prevention]
Placebo Comparator: control group; receiving routine health education and mental health knowledge	Combination product: routine health education and mental health knowledge; routine health education and mental health knowledge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9(PHQ-9)	The score ranges from 0 to 27, the higher scores mean more serious depression	From enrollment to the end of treatment at baseline、12weeks、6months

Secondary Outcome Measures

Outcome Measure	Time Frame
BMI	From enrollment to the end of treatment at baseline、12 weeks、6months

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: Peking University; Center for Disease Control and Prevention of Bejing Economic-Technoloogical Develeopment Area

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: depression; obesity; children; adolescents; effectiveness evaluation; intervention mode
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Overnutrition; Nutrition Disorders; Body Weight; Depression; Depressive Disorder; Obesity; Overweight
• Other Study ID Numbers: CFH2024-1G-2121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No