Study Protocol
Title:

Study of Child Health and Lifestyle during the COVID-19 pandemic

Acronym:
Funder:

SCHL-COV
JSPS KAKENHI Grant Number 21K10441
OYO Electric Co., Ltd.
Research Ethics Committee of the Graduate School of Medicine,
Chiba University
3909
1.6
June 23, 2022
Chisato Mori
Department of Bioenvironmental Medicine, Graduate School ofMedicine, Chiba University
1-8-1 Inohana, Chuo-ku, Chiba+81-43-226-2015
cmori@faculty.chiba-u.jp
Midori Yamamoto
Center for Preventive Medical Sciences, Chiba University
1-33 Yayoi-cho, Inage-ku, Chiba+81-43-290-3896
midoriy@faculty.chiba-u.jpIRB:IRB Number:Protocol Version:
Protocol Date:
Principal Investigator:
Institution:
Office Address:
Telephone:
Email:
Correspondence:
Institution:
Office Address:
Telephone:
Email:

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Abbreviations
BDHQ: Brief-type Self-administered Diet History Questionnaire
CAVI: Cardio Ankle Vascular Index
COVID-19: Coronavirus Disease 2019
K6: Kessler Psychological Distress Scale
SARS-CoV-2: Severe Acute Respiratory Syndrome Coronavirus 2
QOL: Quality of Life

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Table of Contents
1. Background Information ............................................................................................ 4
2. Study Objectives ........................................................................................................ 4
3. Study Population ........................................................................................................ 4
4. Study Procedures ....................................................................................................... 55. Study Period ............................................................................................................... 76. Potential Benefits and Disadvantages ........................................................................ 7
7. Informed Consent....................................................................................................... 7
8. Addressing Clinical Adverse Events .......................................................................... 7
9. Protecting Personal Information ................................................................................ 7
10. Research Funding and Conflicts of Interest ........................................................... 8
11. Secondary Use of Samples and Information .......................................................... 812. Research Organization............................................................................................ 813. Records Storage ...................................................................................................... 9
14. Publication of Research Results ............................................................................. 9
15. Financial Burden or Payments for Study Population ............................................. 93

1. Background Information
As a measure for the prevention of the spread of the new coronavirus disease (COVID-19) thatbroke out in Japan in January 2020, schools were temporarily closed and voluntary curfews wereimplemented in March 2020. This has resulted in a lack of exercise, changes in eating habits, anddisrupted lifestyles. Additionally, concerns have arisen about increased stress and depression anddecreased quality of life (QOL) due to changes in the home and learning environment andreduced social interaction. The Japan Pediatric Society has highlighted that the indirect healthhazards, such as the physical and mental effects of school closures, are expected to outweigh thedirect effects of COVID-19 on children. After the emergency declaration was lifted in May 2020,
activities gradually resumed, including decentralized school attendance. However, concerns
remain regarding the persistent physical and psychological effects of these measures on children.
A lack of knowledge persists regarding the relationship between COVID-19 infection status andlifestyle in children, as well as the effects of lifestyle changes on their physical and mental health.
This study employs a longitudinal survey of children to gain insights into these abovementioned
issues.
2. Study Objectives(1) Trends over time in COVID-19 infections among children and their relationship with lifestyleand background factors
Outcome measures: Seropositivity of SARS-CoV-2 antibodies(2) Relationship between lifestyle changes and children's health status following temporaryschool closures and refraining from going out
Outcome measures: Body size, blood lipids, cardio-ankle vascular index (CAVI), bone mass/bonedensity, blood vitamin D (25(OH)D), depression, and quality of life.
Exposures: Energy and nutrient intake, eating habits and behavior, physical activity, sleep,
electronic media use, and lessons learned
Significance of the Study: To contribute to health and hygiene in the community and school
educational settings by providing insights that can aid in infection prevention and themaintenance of the mental and physical well-being of children.
3. Study Population
Participants: Elementary school students
Institution/location for data collection: A university-attached elementary school
Potential subjects/students: 630
Selection criteria: All students
Exclusion criteria: None4

Because this study aims to assess children's health, it is essential that children be the participants.
4. Study Procedures
4.1. Observational Study Design
Prospective and retrospective
Longitudinal cohort studies
4.2. Methods
4.2.1 Participant Registration
The explanatory and consent documents for parents and assent documents for children are
distributed and collected in elementary schools.
The registration of children is based on written parental consent and the child's written
informed assent.
4.2.2 Observation, examination, survey and reporting items and schedule(1) Background: Grade (years), date of birth, sex(2) School records: height, weight, medical history, physical fitness, and health examinations(from the first grade of elementary school).
(3) Child’s Questionnaire (3rd grade and above; twice a year in the first year and once a year in
the second and third years)
・ Health-related quality of life (KIDSCREEN)・ Waking and sleeping times
・ Screen time for electronic media and games other than study
・ Outdoor activity time・ Dietary Questionnaire (BDHQ15y, completed with parent/guardian)(4) Parents’ Questionnaire (twice a year for the first year and once a year for the second andthird years)
・ Basic information: Family structure, parental age, parental education, household income,parental employment status, financial status, and family environment.
・・・・・・・・・Pet ownership
Stressful life events
Depression and anxiety of mothers (K6)Children's school attendance, after-school childcare, and lessons
Children's waking and sleeping times
Children's screen time for electronic media and games other than learning
Outdoor activity time
Eating habitsChildren's stress reactions
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・ Timing of first menstruation in girls
・ History of COVID-19 infection(5) Physical activity measurement (wearing physical activity trackers for one week)(6) Blood tests (8 ml collected)
・ Anti-SARS-CoV-2 antibodies (IgG, IgM)
・ Lipids
・ Vitamin D (25(OH)D)(7) Physical examinations
・・・・・Blood pressure
Height, weight, and abdominal circumference
Body fat percentage and muscle mass
Bone mass/density
CAVI (including heart rate, and upper and lower extremity blood pressure)

4.2.3 Research schedule
1st year
Initial2nd year

3rd year

6 months

Informed consent/assent◯Child’s questionnaire (grade 3 and above)

◯◯

◯

◯

Parent’s questionnaire

◯◯

◯

◯

Physical activity

◯

◯

◯

Blood test
Blood pressure
Height/weight/abdominal circumference
Bone mass/density
CAVI◯

◯

◯

School records transcription
Height, weight, medical history
Physical fitness/health checkup◯◯◯

The survey continues after students reach middle school age.
4.2.4 Summary of Analysis
1) Outcome measures (children)
Seropositivity of anti-SARS-CoV-2
Body mass index (BMI)
Blood lipids
Blood vitamin D (25(OH)D)6

Stress response and health-related QOL(2) Analysis Methods
・ Annual statistics for anti-SARS-CoV-2 seropositivity
・ Multivariate analysis to explore lifestyle, diet-related, and family environment factors
associated with outcome.
5. Study Period
1) Subject enrollment period: December 2020
2) Subject observation period: December 2020 – December 2023
3) Period of study implementation: December 2020 – June 2025
Continuation applications will be filed with the IRB for changes to the study plan. An annual
report will be submitted annually.
6. Potential Benefits and Disadvantages
・ Benefit: Parents will be given a brief report on their children’s blood lipid levels, vitamin Dlevels, blood pressure, body composition, physical activity, and dietary questionnaires.
・ Disadvantage: A volume of 8 ml of blood is drawn from the child per year.
7. Informed Consent
・ Explanation and consent/assent documents approved by the IRB will be provided to children
and their parents throughout elementary school.
As the school assembly is restricted as a measure to prevent COVID-19 infection, sufficient
explanation will be provided in the document only, and any questions will be handled
through a telephone inquiry desk.
・ Investigators obtain written voluntary consent from the surrogate (the child's parent) andwritten voluntary assent from the child.
The investigators explain that the child's wishes should be respected during the decisionmaking process.
8. Addressing Clinical Adverse Events
As this is not an intervention study, no health hazards are assumed in principle and no special
compensation will be provided.
A single blood draw of 8 ml from children is considered safe for health.
If a child feels unwell during blood collection, blood collection should be stopped immediately
and appropriate action should be taken by the physician.
9. Protecting Personal Information
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(1) Anonymization of samples/data and the possibility of linkage with personal information:
Samples and data collected from participating children or their parents will be collected alongwith the child's name. However, all samples and data will have their names removed aftercollection and will be assigned a personal identification number. The personal information andsamples/data will be linked in a correspondence table.
(2) Scope of data handlers handling personal information
All data, including personal information, will be handled by the Data Manager of the Chiba
University Center for Preventive Medicine.
(3) Handling of data after the withdrawal of consent.
Samples and data will be discarded after the withdrawal of consent, except for data that must beretained for publication of research results. Anonymized samples will be discarded afterremoving labels and contents. Documents and other materials will be shredded and incinerated,and information stored on external computer storage devices will be deleted. The personal
information manager will erase the information stored on the external storage device of thecomputer.
For participants who have requested to discontinue cooperation, the samples and data collected
up to that point will not be discarded and will be used for the research.
(4) Method for managing correspondence tables
Correspondences between personal information and identification numbers shall be stored on acomputer that is not linked to another computer.
An external storage device that stores information must be maintained in a locked vault understrict control.
10. Research Funding
Operating expense grants, contracted research expenses, and Grants-in-Aid for scientific researchexpenses from the Ministry of Education, Culture, Sports, Science, and Technology.
11. Secondary Use of Samples and Information
Secondary use of the samples and information and their provision to other research institutions
has not been planned.
12. Research Organization
Center for Preventive Medical Sciences, Chiba University
Department of Bioenvironmental Medicine, Graduate School of Medicine, Chiba University
Department of Clinical Medicine, Faculty of Education, Chiba University
8Attached Elementary School of Faculty of Education, Chiba University
Faculty of Nutrition, Kagawa Nutrition University
OYO Electric Co., Ltd.
Fukuda Denshi Co., Ltd.
13. Storage of Records(1) Storage of documents
Person responsible for storage: Chisato Mori
Storage location: Locked vaults in the data room at the Center for Preventive Medicine
Storage period: 10 years(2) Sample Storage
Samples: Blood, plasma, serum
Person responsible for storage: Chisato Mori
Storage location: Locked biobank room at the Center for Preventive Medicine
Storage period: 10 years
14. Publication of Research Results
The results will be presented in academic papers and at conferences. Information that canidentify individuals will not be included in the content of the presentation.
15. Financial Burdens or Payments for Study Population
There is no cost to participants.
There will be a cost for recharging the physical activity trackers.
No rewards will be given for participation in the study.

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