Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
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|ClinicalTrials.gov Identifier: NCT05275959|
Recruitment Status : Not yet recruiting
First Posted : March 11, 2022
Last Update Posted : April 4, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Obesity Myopia||Other: Multidimensional non-drug instrumental intervention||Not Applicable|
The investigators plan to follow the child every three months for a year. Data were collected every 3 months for a total of 5 follow-up data collections (baseline, 3 months, 6 months, 9 months, and 12 months). The contents of each follow-up included questionnaire collection, anthropometric measurement, body composition measurement, visual acuity measurement, blood pressure measurement, venous blood extraction, etc., as well as family questionnaire, school questionnaire, community hospital and project hospital intervention doctor questionnaire. In the first, third and fifth follow-up visits, 2-3 ml of venous blood should be collected.
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 3 venous blood collections, urine and saliva collections during the year (at the initial stage and at the 3rd follow-up, respectively).
Blood sample testing: 2-3ml of venous blood (about 1/2 of the bottle cap of mineral water) 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 (TCHO), triglyceride (TG), low density lipoprotein cholesterol (LDL-C) and high density lipoprotein cholesterol (HDL-C) )).
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. Before urinating in the middle of the urine, students should be asked to clean the urethral opening and surrounding skin with warm water to avoid the contamination of secretions. 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Estimated Study Start Date :||May 1, 2022|
|Estimated Primary Completion Date :||December 1, 2023|
|Estimated Study Completion Date :||December 1, 2024|
The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.
Other: Multidimensional non-drug instrumental intervention
The intervention group adopted an intervention strategy based on the RE-AIM framework with 22510S as the core.
22510S is a set of intervention strategies where "2" is 2 hours or more of outdoor physical activity per day for school-aged children, of which 1 hour should be moderate-to-vigorous physical activity; "2" is no more than 2 hours per day of television viewing or screen-based electronics use. "5", school-age children should eat 5 portions of vegetables and fruit the size of an adult's fist, about 300 to 500 grams of cooked or chopped raw vegetable leaves and about 200 to 400 grams of fruit per day; "1", 1 portion of meat per day, equivalent to 1 adult hand The "1" is to eat one portion of meat per day, the size and thickness of one adult hand, about 80 to 110 grams; the "0" is to not drink sugary drinks; and the "S" is for school-age children to get a reasonable amount of sleep each day.
Other Name: Myopia and Obesity Comorbidity intervention
No Intervention: Control
health education class
- Myopia changes [ Time Frame: Visual acuity testing measured every three months, 3rd, 6th, 9th, 12th months ]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.
- Height changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]The record is in centimeters and accurate to one decimal place.
- Weight changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]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.
- Waist circumference changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]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);
- Skinfold thickness changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]Find the exact position, gently pinch the skin and subcutaneous tissue (do not pinch muscle tissue) with the left thumb and index finger at the tested part, and the distance between the two fingers is 3 cm;
- Body composition changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]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.
- Blood pressure changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]The upper arm medical electronic sphygmomanometer certified by the international standard scheme is used for measurement.
- Blood biochemical indexes changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]Venous blood was collected and operated on by professional nurses.
- Saliva test [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]Collect early morning saliva samples
- Urine sample detection changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]The collected urine samples are stored in a 5ml centrifuge tube and stored in a refrigerator at - 20 ℃.
- Night lighting changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]Put the photometer on the bedside table of the bedroom and program it to continuously collect light information every 60 seconds.
- Sleep changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]Children wear three-axis Actigraph GT3X + activity recorder (removed when taking a bath) in their nonpreferred hands for 24 hours for 7 consecutive days.
- activity records changes [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]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.
- Student Questionnaire [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]"Student Questionnaire" is organized by students to fill in at school;
- Parent Questionnaire [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]"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.
- school questionnaire [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]Participants' school fill-in.
- Community Hospitals Questionnaire [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]It shall be filled in by the personnel of the hospital participating in the project
- Medical Institutions Questionnaire [ Time Frame: Measured every three months, 3rd, 6th, 9th, 12th months ]It shall be filled in by the personnel of the medical institution participating in the project
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|Ages Eligible for Study:||6 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- At 6-17 years old。
- The physical examination information at school is complete.
- There is no transfer plan within one year.
- There are ophthalmic device diseases, such as keratitis, corneal ulcer, etc.;
- History of ophthalmic surgery, such as laser surgery;
- Visual problems such as color weakness and color blindness;
- Suffering from major organ diseases or endocrine diseases;
- History of heart, lung, kidney and other important organ diseases;
- Abnormal physical development;
- Can not participate in school sports activities;
- Have any weight loss behaviors such as inducing vomiting or taking weight loss drugs;
|Responsible Party:||Peking University|
|Other Study ID Numbers:||
|First Posted:||March 11, 2022 Key Record Dates|
|Last Update Posted:||April 4, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Children and adolescents, myopia, obesity, intervention,