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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025384
Receipt No. R000029225
Scientific Title Examination of nutritional education on soft drink intake for children dwelling in a children's home
Date of disclosure of the study information 2016/12/23
Last modified on 2017/12/29

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Basic information
Public title Examination of nutritional education on soft drink intake for children dwelling in a children's home
Acronym Examination of nutritional education on soft drink intake for children dwelling in a children's home
Scientific Title Examination of nutritional education on soft drink intake for children dwelling in a children's home
Scientific Title:Acronym Examination of nutritional education on soft drink intake for children dwelling in a children's home
Region
Japan

Condition
Condition Child
Classification by specialty
Not applicable Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examining of a healthy-food practice approach for soft drink intake
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amounts and Times of Soft drink intake 1week after nutrition education
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 NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Group nutrition education(2time) and change of food environment
Interventions/Control_2 Group nutrition education(1time) and change of food environment
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
13 years-old <=
Age-upper limit
18 years-old >=
Gender Female
Key inclusion criteria Junior and senior high school students
children dwelling in a children's home
Key exclusion criteria not selected
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukari Takemi
Organization Kagawa nutrition university
Division name Nutrition ecology
Zip code
Address 3-9-21 Chiyoda, Sakado, Saitama
TEL 049-282-3721
Email takemi@eiyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nozomi Takahashi
Organization Chiba Local Government Health and Welfare Department
Division name Health Promotion Support Division
Zip code
Address 1-1 Ichiba-chou,chuo-ku, Chiba-city, Chiba
TEL 043-223-2667
Homepage URL
Email n.sn2@pref.chiba.lg.jp

Sponsor
Institute Kagawa nutrition university
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 12 Month 23 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 Completed
Date of protocol fixation
2016 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 28 Day
Last follow-up date
2017 Year 02 Month 01 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 23 Day
Last modified on
2017 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029225

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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