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

Primary Purpose

Obesity, Myopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multidimensional non-drug instrumental intervention
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Children and adolescents, myopia, obesity, intervention,

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. At 6-17 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. Suffering from major organ diseases or endocrine diseases;
  5. History of heart, lung, kidney and other important organ diseases;
  6. Abnormal physical development;
  7. Can not participate in school sports activities;
  8. Have any weight loss behaviors such as inducing vomiting or taking weight loss drugs;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    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.

    health education class

    Outcomes

    Primary Outcome Measures

    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.
    Height changes
    The record is in centimeters and accurate to one decimal place.
    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.
    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);
    Skinfold thickness changes
    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
    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
    The upper arm medical electronic sphygmomanometer certified by the international standard scheme is used for measurement.
    Blood biochemical indexes changes
    Venous blood was collected and operated on by professional nurses.
    Saliva test
    Collect early morning saliva samples
    Urine sample detection changes
    The collected urine samples are stored in a 5ml centrifuge tube and stored in a refrigerator at - 20 ℃.
    Night lighting changes
    Put the photometer on the bedside table of the bedroom and program it to continuously collect light information every 60 seconds.
    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.
    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.
    Student Questionnaire
    "Student Questionnaire" is organized by students to fill in at school;
    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.
    school questionnaire
    Participants' school fill-in.
    Community Hospitals Questionnaire
    It shall be filled in by the personnel of the hospital participating in the project
    Medical Institutions Questionnaire
    It shall be filled in by the personnel of the medical institution participating in the project

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2022
    Last Updated
    March 23, 2022
    Sponsor
    Peking University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05275959
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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. Hetongzhou District selected 24 intervention schools (about 20,000) and 12 control schools (about 10,000) 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, a one-year 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Myopia
    Keywords
    Children and adolescents, myopia, obesity, intervention,

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    health education class
    Intervention Type
    Other
    Intervention Name(s)
    Multidimensional non-drug instrumental intervention
    Other Intervention Name(s)
    Myopia and Obesity Comorbidity intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Myopia changes
    Description
    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.
    Time Frame
    Visual acuity testing measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Height changes
    Description
    The record is in centimeters and accurate to one decimal place.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Weight changes
    Description
    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.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Waist circumference changes
    Description
    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);
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Skinfold thickness changes
    Description
    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;
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Body composition changes
    Description
    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.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Blood pressure changes
    Description
    The upper arm medical electronic sphygmomanometer certified by the international standard scheme is used for measurement.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Blood biochemical indexes changes
    Description
    Venous blood was collected and operated on by professional nurses.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Saliva test
    Description
    Collect early morning saliva samples
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Urine sample detection changes
    Description
    The collected urine samples are stored in a 5ml centrifuge tube and stored in a refrigerator at - 20 ℃.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Night lighting changes
    Description
    Put the photometer on the bedside table of the bedroom and program it to continuously collect light information every 60 seconds.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Sleep changes
    Description
    Children wear three-axis Actigraph GT3X + activity recorder (removed when taking a bath) in their nonpreferred hands for 24 hours for 7 consecutive days.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    activity records changes
    Description
    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.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Student Questionnaire
    Description
    "Student Questionnaire" is organized by students to fill in at school;
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Parent Questionnaire
    Description
    "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.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    school questionnaire
    Description
    Participants' school fill-in.
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Community Hospitals Questionnaire
    Description
    It shall be filled in by the personnel of the hospital participating in the project
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months
    Title
    Medical Institutions Questionnaire
    Description
    It shall be filled in by the personnel of the medical institution participating in the project
    Time Frame
    Measured every three months, 3rd, 6th, 9th, 12th months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At 6-17 years old。 The physical examination information at school is complete. There is no transfer plan within one year. Exclusion Criteria: 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;

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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