UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039022 |
|---|---|
| Receipt number | R000044487 |
| Scientific Title | A study to examine the effects of nonpharmaceutical interventions among school children on community mitigation for influenza Study 2 A pilot study for large-scale intervention studies |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2019/12/27 16:20:09 |
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Basic information
Public title
An intervention study for influenza prevention among school children
Acronym
An intervention study for influenza prevention
Scientific Title
A study to examine the effects of nonpharmaceutical interventions among school children on community mitigation for influenza
Study 2 A pilot study for large-scale intervention studies
Scientific Title:Acronym
A pilot study of nonpharmaceutical interventions for influenza prevention
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of influenza prevention among elementary school children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
influenza infection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
hand hygiene (+)
green tea drinking (+)
intervention contents are explained
hand hygiene: frequent hand washing and use of alcohol-based hand sanitizers
green tea drinking: frequent consumption of small amounts (30ml) of green tea
Interventions/Control_2
hand hygiene (+)
green tea drinking (-)
intervention contents are explained
hand hygiene: frequent hand washing and use of alcohol-based hand sanitizers
Interventions/Control_3
hand hygiene (-)
green tea drinking (-)
(-) means that there is no intervention to encourage active implementation, and the subject's daily behaviors are not suppressed.
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elementary school children, whose parents have given consent to participate in the study, with no alcohol sensitivity and no green tea allergy
Key exclusion criteria
Elementary school children without parental consents to participate in the study
Elementary school children with alcohol sensitivity
Elementary school children with green tea allergy
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Seki |
Organization
Niigata University
Division name
School of Health Sciences
Zip code
951-8518
Address
2-746 Asahimachi-dori, Chuo-ku Niigata 951-8518, JAPAN
TEL
025-227-0960
nao@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Nao |
| Middle name | |
| Last name | Seki |
Organization
Niigata University
Division name
School of Health Sciences
Zip code
951-8518
Address
2-746 Asahimachi-dori, Chuo-ku Niigata 951-8518, JAPAN
TEL
025-227-0960
Homepage URL
nao@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics committee of Niigata University
Address
1-754 Asahimachi-dori, Chuo-ku Niigata 951-8520, JAPAN
Tel
025-227-2625
ethics@adm.niigata-u.ac.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
| 2020 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044487
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
