UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040336 |
|---|---|
| Receipt number | R000046031 |
| Scientific Title | Study on the effects of dietary education on the basis of breakfast intake of schoolchildren for different subjects |
| Date of disclosure of the study information | 2020/05/08 |
| Last modified on | 2021/10/14 11:20:32 |
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Basic information
Public title
Study on the effects of dietary education on the basis of breakfast intake of schoolchildren for different subjects
Acronym
Study on the effects of dietary education on the basis of breakfast intake of schoolchildren
Scientific Title
Study on the effects of dietary education on the basis of breakfast intake of schoolchildren for different subjects
Scientific Title:Acronym
Study on the effects of dietary education on the basis of breakfast intake of schoolchildren
Region
| Japan |
Condition
Condition
Healthy children
Healthy adults
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual condition of schoolchildren's breakfast contents and the effects of dietary education on the basis of breakfast intake for different subjects (children and/or their parents).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of balanced breakfast intake
Key secondary outcomes
Awareness of breakfast intake, food and nutrient intakes, and health status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Schoolchildren receive a dietary education about balanced breakfast (once in class and twice during school lunch).
Their parents receive a dietary education about balanced breakfast (twice distribution of educational materials).
Interventions/Control_2
Schoolchildren receive a dietary education about balanced breakfast (once in class and twice during school lunch).
Their parents do not receive the dietary education.
Interventions/Control_3
Schoolchildren do not receive a dietary education.
Their parents receive a dietary education about balanced breakfast (twice distribution of educational materials).
Interventions/Control_4
Neither schoolchildren nor their parents receive a dietary education.
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
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Fifth grade children belonging to elementary school in the area
Key exclusion criteria
Not applicable
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Toshiko |
| Middle name | |
| Last name | Kuwano |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
TEL
054-264-5513
kuwano@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Toshiko |
| Middle name | |
| Last name | Kuwano |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
TEL
054-264-5513
Homepage URL
kuwano@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka 422-8526, Japan
Tel
054-264-5103
tyous10@u-shizuoka-ken.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 | 05 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2021 | 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
| 2020 | Year | 05 | Month | 08 | Day |
Last modified on
| 2021 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046031
| 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 |
