UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046126 |
|---|---|
| Receipt number | R000052648 |
| Scientific Title | Study of Child Health and Lifestyle during COVID-19 pandemic |
| Date of disclosure of the study information | 2021/11/20 |
| Last modified on | 2025/06/02 11:13:18 |
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Basic information
Public title
Study of Child Health and Lifestyle during COVID-19 pandemic
Acronym
SCHL-COV
Scientific Title
Study of Child Health and Lifestyle during COVID-19 pandemic
Scientific Title:Acronym
SCHL-COV
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the relationship between children's lifestyle and health during COVID-19 pandemic
Basic objectives2
Others
Basic objectives -Others
Obesity
Bone density
Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Obesity
Bone density
QOL (quality of life)
Others
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elementary school student
Key exclusion criteria
None
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Sakurai |
Organization
Chiba University
Division name
Center for Preventive Medical Sciences
Zip code
263-8522
Address
1-33 Yayoi-cho, Inage-ku, Chiba
TEL
043-290-3896
sakuraik@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Yamamoto |
Organization
Chiba University
Division name
Center for Preventive Medical Sciences
Zip code
263-8522
Address
1-33 Yayoi-cho, Inage-ku, Chiba
TEL
043-290-3896
Homepage URL
midoriy@faculty.chiba-u.jp
Sponsor or person
Institute
Center for Preventive Medical Sciences, Chiba University
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-226-2462
inohana-rinri@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
https://cpms.chiba-u.jp/en/research/Study%20protocol.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
355
Results
Of the 639 students at the school, 355 aged 6-12 years were enrolled (participation rate, 55.6%).
Results date posted
| 2024 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Grade 1-3 (Elementary school): 52%
Boys: 49%
Participant flow
Of the 639 students at the school, 355 were enrolled.
Adverse events
None
Outcome measures
Seropositivity of anti-SARS-CoV-2
Body mass index (BMI)
Blood lipids
Blood AST, ALT
Blood vitamin D (25(OH)D)
Stress response and health-related QOL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Factors: lifestyle, eating habits, physical activity, sleep, others
Management information
Registered date
| 2021 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052648
