UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029252 |
|---|---|
| Receipt number | 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 | 2024/03/28 09:12:54 |
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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
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
JZF01334@nifty.ne.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
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
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
https://www.toho-u.ac.jp/med/gakunai/ethical_committee1/syonin_ichiran/index.html
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8600693/
Number of participants that the trial has enrolled
2379
Results
Nutrition knowledge was improved, and its disparity was alleviated
Results date posted
| 2024 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
5th and 6th grader children belonging to public primary schools in Japan and their guardians
Participant flow
recruited from primary schools
Adverse events
None
Outcome measures
Nutrition knowledge, Lifestyle
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
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033432
| 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 |
