UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053966 |
|---|---|
| Receipt number | R000061596 |
| Scientific Title | Effect of "3, 1, 2 Bento Box Method" of education on nutrition |
| Date of disclosure of the study information | 2024/03/25 |
| Last modified on | 2025/03/27 08:26:38 |
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Basic information
Public title
Effect of "3, 1, 2 Bento Box Method" of education on nutrition on improving lifestyle and eating behavior
Acronym
Effect of "3, 1, 2 Bento Box Method" of education on nutrition
Scientific Title
Effect of "3, 1, 2 Bento Box Method" of education on nutrition
Scientific Title:Acronym
Effect of "3, 1, 2 Bento Box Method" of education on nutrition
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to verify the effectiveness of the "3-1-2 Bento Box Method" in improving the diet of the younger generation and to establish an effective method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Living Conditions
Dietary intake status using the FFQ
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are 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
| Behavior,custom |
Interventions/Control_1
Attend specialized classes on the "3-1-2 Bento Box Method."
Interventions/Control_2
Not taking classes(control)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Newly enrolled students in the Department of Nutrition, Faculty of Science, Kio University, who have agreed to participate in the research.
Key exclusion criteria
No setting
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Nohara |
Organization
Kio University
Division name
Faculty of Health Sciences
Zip code
6350832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
TEL
0745541601
j.nohara@kio.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Nohara |
Organization
Kio University
Division name
Faculty of Health Sciences
Zip code
6350832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
TEL
0745541601
Homepage URL
j.nohara@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Junko Nohara
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
Tel
0745541601
j.nohara@kio.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
| 2024 | Year | 03 | Month | 25 | 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
90
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
| 2024 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 03 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061596
