Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)

NCT ID: NCT05275959

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3963 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2024-06-30

Brief Summary

Based on the RE-AIM framework, this project intends to integrate the prevention and control measures of myopia and obesity, and establish a set of key suitable technical packages and guarantee systems for the "comorbidity-common-cause-common prevention" of myopia and obesity in children and adolescents. Dong cheng ,Tongzhou and Changping District in total selected 18 intervention schools and 18 control schools to apply the application, integrate the resources of the "family-school-community-medical institution", and establish a comprehensive combination of myopia and obesity in children and adolescents In the prevention and control demonstration area, intervention study was conducted to evaluate the comprehensive intervention effect of myopia and obesity in children and adolescents in the demonstration area, and to promote it through the regional monitoring system in Beijing. This project is the first time to establish a district-level comprehensive prevention and control demonstration area for children and adolescents with myopia and obesity that can be promoted, including key appropriate technology packages and promotion and application strategies. Healthy Beijing 2030" plan laid the foundation.

Detailed Description

Baseline (March-April 2023), first follow-up (July-August 2023), and second follow-up (November-December 2023). The collection of data from study participants at baseline and third follow-up included questionnaire collection, anthropometric indicators, body composition measurements, vision measurements, blood pressure measurements, urine, saliva, and venous blood draws, as well as home questionnaires, school questionnaires, and interventionist physician questionnaires from the community hospitals and the project hospitals; and the first follow-up (the collection of data varied in each district, and was done according to the level of district cooperation) included questionnaire collection, anthropometric measurements, vision measurements, and blood pressure measurements, as well as home questionnaires, school questionnaires, and interventionist physician questionnaires from the community hospitals and the project hospitals.

Myopia and activity records: including nighttime lighting, wake-sleep cycles, and movement. As well as family questionnaires, school questionnaires, community hospitals and project hospital intervention doctor questionnaires. All inspection items are operated by trained and qualified doctors and professional health technicians. The inspection will be arranged in the school, and the whole process is the same as the regular physical examination in the school.

The child required 2 venous blood collections, urine and saliva collections during the year (at the initial stage and at the 3rd follow-up, respectively).

Blood sample testing: 10ml of venous blood is drawn each time for blood routine and blood biochemistry. The blood process is safe. Blood samples include: blood biochemical indicators (fasting blood glucose (FBG), insulin, total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) ) and so on).

Hormone testing: Collect saliva samples in the morning and purchase ELISA kits to measure levels of thyroid hormones, estradiol and testosterone.

Urine sample testing: use polypropylene urine cups and urine collection tubes (without PAEs plasticizers) to collect 10 mL of urine from the research subjects, and reserve the sample to collect the first excretion after getting up in the morning, before breakfast and before exercising. The collected urine samples were uniformly stored in a 5mL centrifuge tube and stored in a -20°C refrigerator. Urine PAEs and their metabolites: Ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was used to detect seven PAEs metabolites in students' urine: monomethyl phthalate (MMP), phthalic acid Monoethyl ester (MEP), mono-n-butyl phthalate (MBP), mono(2-ethylhexyl) phthalate (MEHP), mono(2-ethyl-5-phthalate) Hydroxyhexyl) ester (MEHHP), mono(2-ethyl-5-oxohexyl) phthalate (MEOHP).

The content of the family and student questionnaires will include general conditions of children, general conditions of parents and families, as well as daily diet, physical activity and sleep. The name of the child will only be used for tracking and will be deleted after one year of observation to ensure that the information of the child and participants will not be leaked. All members of the project team have signed a confidentiality agreement, and all information in the questionnaire will not be leaked to the outside world.

Conditions

Obesity; Myopia

Keywords

Children; Adolescents; Myopia; Obesity; Cluster randomized controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

"22510SS" Intervention

Intervention measures will be taken against children and adolescents' myopia and obesity at four levels: individual (individual centered activities), environment (supportive family and school settings), and supervision (family, school, program team, and clinical) and feedback (timely feedback from the WeChat applet).

Group Type: OTHER

A cluster randomized trial of a comprehensive intervention nesting family and clinic into school centered implementation to reduce myopia and obesity among children and adolescents in Beijing, China

Intervention Type: OTHER

Myopia and obesity in children and adolescents have become serious public health problems that endanger public health, especially in China. Unhealthy lifestyle behaviors are environmental drivers of both myopia and obesity. This protocol describes a study to evaluate the effectiveness of "22510SS", that is 2 h of daytime outdoor activities ('2'); Limit screen time to no more than 2 h per day ('2'); Consume at least 5 servings of fruits and vegetables daily ('5'); Attain 1 h of physical activity daily ('1'); Consume 0 sugar-sweetened beverages ('0'); Reasonable sleep duration ('S'); Regular supervision ('S'). A school-based, multifaceted intervention strategy for myopia and obesity prevention, and to assess and explore the implementation of "22510SS" with regards to acceptability, feasibility, adoption, usage and maintenance.

Control

Regular health education without extra intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

A cluster randomized trial of a comprehensive intervention nesting family and clinic into school centered implementation to reduce myopia and obesity among children and adolescents in Beijing, China

Myopia and obesity in children and adolescents have become serious public health problems that endanger public health, especially in China. Unhealthy lifestyle behaviors are environmental drivers of both myopia and obesity. This protocol describes a study to evaluate the effectiveness of "22510SS", that is 2 h of daytime outdoor activities ('2'); Limit screen time to no more than 2 h per day ('2'); Consume at least 5 servings of fruits and vegetables daily ('5'); Attain 1 h of physical activity daily ('1'); Consume 0 sugar-sweetened beverages ('0'); Reasonable sleep duration ('S'); Regular supervision ('S'). A school-based, multifaceted intervention strategy for myopia and obesity prevention, and to assess and explore the implementation of "22510SS" with regards to acceptability, feasibility, adoption, usage and maintenance.

Intervention Type: OTHER

Other Intervention Names

Myopia and Obesity Comorbidity intervention

Eligibility Criteria

Inclusion Criteria

1. At 6-14 years old。

2. The physical examination information at school is complete.

3. There is no transfer plan within one year.

Exclusion Criteria

1. There are ophthalmic device diseases, such as keratitis, corneal ulcer, etc.;

2. History of ophthalmic surgery, such as laser surgery;

3. Visual problems such as color weakness and color blindness;

4. History of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis, or nephritis;

5. Obesity caused by endocrine diseases or side effects of drugs;

6. Abnormal physical development, such as dwarfism or gigantism;

7. Can not participate in school sports activities;

8. Have any weight loss behaviors such as inducing vomiting or taking weight loss drugs in past three months;

9. Body deformities, such as severe scoliosis, chicken breasts, limps, pronounced O-or X-legs.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tongzhou District Primary and Secondary School Health Care Institute

Beijing, Beijing Municipality, China

Dongcheng Primary and Secondary School Health Care Center

Beijing, , China

Health Education Center forPrimary and Secondary Schools Changping

Beijing, , China

Countries

China

References

Wang X, Dang J, Liu J, Liu Y, Wang Y, Shi D, Chen Z, Yuan W, Cai S, Mi J, Xiao P, Li L, Fan Y, Gao A, Chen H, Zhuang L, Yu Z, Li J, Yang D, Yang G, Guo L, Li Y, Song J, Li J, Ma J, Dong Y, Song Y. A cluster randomized trial of a comprehensive intervention nesting family and clinic into school centered implementation to reduce myopia and obesity among children and adolescents in Beijing, China: study protocol. BMC Public Health. 2023 Jul 27;23(1):1435. doi: 10.1186/s12889-023-16270-x.

Reference Type: DERIVED

PMID: 37501063 (View on PubMed)

Other Identifiers

Yi Song2022

Identifier Type: -

Identifier Source: org_study_id