UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058394 |
|---|---|
| Receipt number | R000066761 |
| Scientific Title | Evaluating the Impact of a Lesson on Planning Balanced Meals to Foster Non-Cognitive Skills |
| Date of disclosure of the study information | 2025/07/09 |
| Last modified on | 2025/07/11 18:53:10 |
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Basic information
Public title
Evaluating the Impact of a Lesson on Planning Balanced Meals to Foster Non-Cognitive Skills
Acronym
Evaluating the Impact of a Lesson on Planning Balanced Meals to Foster Non-Cognitive Skills
Scientific Title
Evaluating the Impact of a Lesson on Planning Balanced Meals to Foster Non-Cognitive Skills
Scientific Title:Acronym
Evaluating the Impact of a Lesson on Planning Balanced Meals to Foster Non-Cognitive Skills
Region
| Japan |
Condition
Condition
Healthy Children
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the impact of a lesson on planning balanced meals to foster non-cognitive skills.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non-cognitive skills measured pre-intervention, post-intervention, and at four-month follow-up.
Key secondary outcomes
Assessment of eating and lifestyle habits associated with non-cognitive skills, and meal planning-related items at pre-intervention, post-intervention, and four-month follow-up.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Home Economics "Let's Plan a Well-Balanced Menu" 6 hours
Interventions/Control_2
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
| 11 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Is enrolled at Toda Municipal Daini Elementary School
2.Parental consent for participation in the study has been obtained
3.Has participated in all parts of the conducted survey
Key exclusion criteria
1. The students who are continuously absent from school due to school refusal etc.
2.The students who are difficult to participate the survey due to health reasons
3.Those who do not have sufficient ability in Japanese to participate in this survey
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Nakanishi |
Organization
Kagawa Nutrition University
Division name
Undergraduate School of Nutrition Sciences
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado Saitama 350-0288 Japan
TEL
049-282-3573
nakanisi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Nakanishi |
Organization
Kagawa Nutrition University
Division name
Undergraduate School of Nutrition Sciences
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado Saitama 350-0288 Japan
TEL
049-282-3573
Homepage URL
nakanisi@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Kagawa Nutrition 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
Kagawa Nutrition University Research Review Committee
Address
049-289-6041
Tel
049-289-6041
kenshien@eiyo.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
| 2025 | Year | 07 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066761
