UMIN-CTR Clinical Trial

Basic information
Public title	Validation of the dietary education program for developing food self-management skill focusing taste perception in school-age
Acronym	Effectiveness of dietary education program in school-age
Scientific Title	Validation of the dietary education program for developing food self-management skill focusing taste perception in school-age
Scientific Title:Acronym	Effectiveness of dietary education program in school-age
Region	Japan

Condition
Condition	None
Classification by specialty	Nursing Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to validate the dietary education program for developing food self-management skill in school-age.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Taste perception
Key secondary outcomes	Self-efficacy Nutrition intakes QOL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	The intervention group takes 6-month dietary education program, and the control group does not take the program.
Interventions/Control_2	The intervention group takes lecture about healthy diet and receives newsletter for parents once every two months.
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	9 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	1.The students who are enrolled at elementary schools in Osaka and Hyogo prefectures 2. The students and their parents/guardian who have agreed to participate in this study 3.The participants who attend all the survey
Key exclusion criteria	1. The students who are continuously absent from school due to school refusal etc. 2.The students who are difficult to participate the survey due to health reasons 3.Those who do not have sufficient ability in Japanese to participate in this survey
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Hiroko Middle name Last name Watanabe
Organization	Osaka University
Division name	Graduate School of Medicine, Health Science
Zip code	565-0871
Address	1-7 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-2520
Email	watanabe@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Hiroko Middle name Last name Watanabe
Organization	Osaka University
Division name	Graduate School of Medicine, Health Science
Zip code	565-0871
Address	1-7 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-2520
Homepage URL
Email	watanabe@sahs.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	Osaka University Research Review Committee
Address	2-2 Yamadaoka, Suita, Osaka, Japan
Tel	06-6210-8289
Email	rinri@hp-crc.med.osaka-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 10 Month 01 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	2020 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 12 Day
Last modified on	2020 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046094

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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