Clinical trial NCT05275959: Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
Official title: Implementation Research on the Construction and Scale Up Regarding To"Comorbidity-Co-causes-Joint-prevention" Comprehensive Demonstration District of Myopia and Obesity Among Children and Adolescents in Beijing Guided by RE-AIM Framework
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Myopia
Keywords: Children
Adolescents
Myopia
Obesity
Cluster randomized controlled trial
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 3963
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Myopia changes
timeFrame: Approximate timing: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Height changes
timeFrame: Approximate timing: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Weight changes
timeFrame: Approximate timing: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Waist circumference changes
timeFrame: Approximate timing: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Hip circumference changes
timeFrame: Approximate timing: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Body composition changes
timeFrame: Approximate timing: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Blood pressure changes
timeFrame: Approximate timing: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Blood glucose change
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Total cholesterol change
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Low-density lipoprotein cholesterol (LDL-C) change
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: High density lipoprotein cholesterol (HDL-C) change
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Triglycerides change
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Uric acid change
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Saliva test
timeFrame: Approximate timing: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Urine sample detection changes
timeFrame: Approximate timing: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Sleep diary
timeFrame: Approximate timing: Measured in the six month of intervention
measure: Night lighting changes
timeFrame: Approximate timing: Measured in the third month of intervention
measure: Basic information-for student
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Knowledge mastery-for student
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Behavior practice-for student
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Myopia and obesity intervention promotion/barrier factors-for student
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Dietary questionnaire-for student
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Physical activity questionnaire-for student
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Sleep questionnaire-for student
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Mental health questionnaire-for student
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Basic information -for patents
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Myopia and obesity status-for patents
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Knowledge mastery-for patents
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Behavior practice-for patents
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Child sleep quality-for patents
timeFrame: Approximate timing: Measured in the baseline and the twelfth month of intervention
measure: Basic information -for doctors of school
timeFrame: Approximate timing: Measured in the sixth month of intervention
measure: Promotion/barrier factors in health working --for doctors of school
timeFrame: Approximate timing: Measured in the sixth month of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tongzhou District Primary and Secondary School Health Care Institute
state: Beijing
city: Beijing
country: China
facility: Dongcheng Primary and Secondary School Health Care Center
city: Beijing
country: China
facility: Health Education Center forPrimary and Secondary Schools Changping
Study officials:
References: