UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052292 |
|---|---|
| Receipt number | R000059694 |
| Scientific Title | A Randomized Controlled Trial to Measure Balanced Guide Proficiency Differences by Order of Class Attendance |
| Date of disclosure of the study information | 2023/09/24 |
| Last modified on | 2025/03/27 08:58:12 |
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Basic information
Public title
Differences in Dietary Balance Guide proficiency levels depending on the order in which students take the "hands-on experience using the nutrition education SAT system" and the "classroom-based class".
Acronym
Balanced guide proficiency differences based on the order of attending hands-on and classroom classes
Scientific Title
A Randomized Controlled Trial to Measure Balanced Guide Proficiency Differences by Order of Class Attendance
Scientific Title:Acronym
A Randomized Controlled Trial to Measure Balanced Guide Proficiency Differences by Order of Class Attendance
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to examine effective methods for promoting and educating the Dietary Balance Guide and to help promote "well-balanced food choices" behavior among the younger generation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proficiency in Dietary Balance Guide
Proficiency in Balanced Diet
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
Take the trial class first and the classroom class later.
Interventions/Control_2
Take the classroom class first, then the trial class.
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
Those who agree to participate in the study from among the university's open campus participants.
Key exclusion criteria
No setting
Target sample size
100
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
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2023 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
85
Results
This study on effective nutrition education methods for balanced food selection suggests that conducting classroom lectures prior to hands-on sessions may enhance participants' understanding, satisfaction, and ability to select nutritionally balanced foods.
Results date posted
| 2025 | Year | 03 | Month | 27 | Day |
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
Main results already published
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 09 | Month | 24 | 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=R000059694
