UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058632 |
|---|---|
| Receipt number | R000067043 |
| Scientific Title | A Study on Current Serving Sizes in Elementary School Lunches and Voluntary Adjustment of Food Intake |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/29 12:02:47 |
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Basic information
Public title
A Study on Current Serving Sizes in Elementary School Lunches and Voluntary Adjustment of Food Intake
Acronym
A Study on Current Serving Sizes in Elementary School Lunches and Voluntary Adjustment of Food Intake
Scientific Title
A Study on Current Serving Sizes in Elementary School Lunches and Voluntary Adjustment of Food Intake
Scientific Title:Acronym
Research on food distribution in elementary school meals
Region
| Japan |
Condition
Condition
No target disease
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
School meals in Japan are prepared based on school meal intake standards, taking into consideration the health and daily activities of children, and are distributed evenly so that each child can consume the necessary amount. However, issues have arisen due to the fact that children are responsible for distributing the meals and can freely adjust the amount after distribution, resulting in inconsistencies in children's meal intake. Variations in meal consumption can lead to imbalances in nutrient intake, affecting growth and health. Similar issues may exist at the elementary school collaborating in this study, but the actual situation and effective meal distribution guidance methods are unclear. Therefore, this study aims to achieve two objectives. (Study1) The first objective is to clarify the current state of meal distribution and consumption quantities among elementary school students at the collaborating school, as well as the reasons why students adjust their portions before eating. (Study2) The second objective is to compare the effects of the intervention by dividing the children into groups based on whether they are provided with equal portions and whether they are allowed to adjust their portions before eating. Through this, the current situation will be clarified, enabling meal distribution guidance tailored to the current situation. Additionally, this will contribute to future meal guidance and is expected to support children's growth in the long term.
Basic objectives2
Others
Basic objectives -Others
Clarify the actual serving and consumption amounts, as well as the reasons why children adjust the amount after being served. Consider effective serving and eating guidance.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Individual portion sizes for children
Individual child's food intake
Key secondary outcomes
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
| Other |
Interventions/Control_1
The intervention period after assessing the actual situation will be 16 days. Participants will be divided into two groups: one group will receive guidance on equal distribution of meals and be allowed to make adjustments after meal distribution, while the other group will receive guidance on equal distribution of meals but will not be allowed to make adjustments after meal distribution. Both groups will participate in the program for 16 days. Guidance on meal distribution will be provided by the homeroom teacher.
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
| 8 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This applies to children in the third grade or above who eat regular school meals.
Key exclusion criteria
Children who require special consideration regarding the content and quantity of school meals.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hoshino |
| Middle name | |
| Last name | Fumi |
Organization
Niigata University of Health and Welfare
Division name
Health and Nutrition
Zip code
9503198
Address
1398 Shimami, Kita-ku, Niigata, 950-3198 JAPAN
TEL
0252574417
fumi-h@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hoshino |
| Middle name | |
| Last name | Fumi |
Organization
Niigata University of Health and Welfare
Division name
Health and Nutrition
Zip code
9503198
Address
1398 Shimami, Kita-ku, Niigata, 950-3198 JAPAN
TEL
0252574417
Homepage URL
fumi-h@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami, Kita-ku, Niigata, 950-3198 JAPAN
Tel
0252574417
fumi-h@nuhw.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
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 01 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 08 | 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 | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067043
