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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029252
Receipt No. R000033432
Scientific Title Diet survey for children and their family in Ibaraki
Date of disclosure of the study information 2018/04/01
Last modified on 2019/03/25

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Basic information
Public title Diet survey for children and their family in Ibaraki
Acronym Diet survey for children and their family in Ibaraki
Scientific Title Diet survey for children and their family in Ibaraki
Scientific Title:Acronym Diet survey for children and their family in Ibaraki
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find factors to promote good dietary habits among children and to develop an effective diet education program
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nutrient intakes, food group intakes, Nutrition knowledge
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 The subjects are devided into two groups, and an intervention by a diet education program will be implemented. One group is educated by the program for three month. After that, another group is educated by the same program.
Interventions/Control_2 two arms
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
10 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) School children in 5th and 6th grade of public elementary school
2) Guardians of the children described above (those who mainly prepare meals for the children)
Key exclusion criteria None
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Keiko
Middle name
Last name Asakura
Organization Toho university
Division name Department of Environmental and Occupational Health, School of Medicine
Zip code 143-8540
Address 5-21-16, Omori-Nishi, Ota-ku, Tokyo 143-8540, Japan
TEL 03-3762-4151
Email JZF01334@nifty.ne.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Asakura
Organization Toho university
Division name Department of Environmental and Occupational Health, School of Medicine
Zip code 143-8540
Address 5-21-16, Omori-Nishi, Ota-ku, Tokyo 143-8540, Japan
TEL 03-3762-4151
Homepage URL
Email JZF01334@nifty.ne.jp

Sponsor
Institute Toho 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 in Toho University, Faculty of Medicine
Address 5-21-16, Omori-Nishi, Ota-ku, Tokyo 143-8540, Japan
Tel 03-3762-4151
Email med.rinri@ext.toho-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
2018 Year 04 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 2379
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 No longer recruiting
Date of protocol fixation
2017 Year 09 Month 06 Day
Date of IRB
2017 Year 09 Month 06 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2022 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
2017 Year 09 Month 22 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033432

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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