UMIN-CTR Clinical Trial

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
Email	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
Email	nao@clg.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044487