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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05275959
• Other study ID #: Yi Song2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 8, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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) ), dehydroepiandrosterone (DHEAS), adrenocorticotrophic hormone(ACTH) 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4500
• Est. completion date: January 1, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Obesity

Intervention

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
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.

Locations

Country	Name	City	State
China	Dongcheng Primary and Secondary School Health Care Center	Beijing
China	Health Education Center forPrimary and Secondary Schools Changping	Beijing
China	Tongzhou District Primary and Secondary School Health Care Institute	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myopia changes	Refer to the "Guidelines for the Prevention and Control of Myopia in Children and Adolescents" issued by the National Health Commission in 2019 to check the vision of children.	Approximate timing: Measured in the third and sixth month of intervention
Primary	Height changes	The record is in centimeters and accurate to one decimal place.	Approximate timing: Measured in the third and sixth month of intervention
Primary	Weight changes	Use an electronic scale and check its accuracy and sensitivity before use. The accuracy error shall not exceed 0.1%, that is, the error per 100kg shall be less than 0.1kg.	Approximate timing: Measured in the third and sixth month of intervention
Primary	Waist circumference changes	A tape ruler was used to measure horizontally around the midpoint of the line between the anterior superior iliac crest and the lower edge of the 12th rib (the thickest part of the waist was selected for obese patients);	Approximate timing: Measured in the third and sixth month of intervention
Primary	Hip circumference changes	The subject stands naturally, with the arms drooping and moderately spread, the feet together, the legs are evenly weighted, the hips are relaxed, and the eyes are straight ahead. The tester places the tape on the most protruding part of the back of the buttocks, and circles the buttocks horizontally. During the test, the tape measure should be close to the skin, and the soft tissue should not be pressed. The reading should be taken when the subject exhales calmly. To ensure that the position of the tape ruler is correct, you can move the tape ruler up and down, compare the readings at different positions, and record the maximum value.	Approximate timing: Measured in the third and sixth month of intervention
Primary	Body composition changes	Using the bioelectrical impedance method, the students hold the hand electrode of the body composition tester, stand on the foot electrode, and complete the measurement in 40 ~ 60 seconds.	Approximate timing: Measured in the third and sixth month of intervention
Primary	Blood pressure changes	The upper arm medical electronic sphygmomanometer certified by the international standard scheme is used for measurement.	Approximate timing: Measured in the third and sixth month of intervention
Primary	Blood biochemical indexes changes	Venous blood was collected and operated on by professional nurses.	Approximate timing: Measured in the six month of intervention
Primary	Saliva test	Collect early morning saliva samples	Approximate timing: Measured in the six month of intervention
Primary	Urine sample detection changes	The collected urine samples are stored in a 5ml centrifuge tube and stored in a refrigerator at - 20 ?.	Approximate timing: Measured in the six month of intervention
Primary	Night lighting changes	Put the photometer on the bedside table of the bedroom and program it to continuously collect light information every 60 seconds.	Approximate timing: Measured in the six month of intervention
Primary	Sleep changes	Children wear three-axis Actigraph GT3X + activity recorder (removed when taking a bath) in their nonpreferred hands for 24 hours for 7 consecutive days.	Approximate timing: Measured in the six month of intervention
Primary	activity records changes	Children wear three-axis Actigraph GT3X + activity recorder (removed when taking a bath) in their non-preferred hands for 24 hours for 7 consecutive days.	Approximate timing: Measured in the six month of intervention
Primary	Student Questionnaire	"Student Questionnaire" is organized by students to fill in at school;	Approximate timing: Measured in the third and sixth month of intervention
Primary	Parent Questionnaire	"Parent Questionnaire" is taken home by students for parents to fill out, and brought back to school to give to teachers within a limited time.	Approximate timing: Measured in the sixth month of intervention
Primary	school questionnaire	Participants' school fill-in.	Approximate timing: Measured in the third month of intervention