UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058507 |
|---|---|
| Receipt number | R000066894 |
| Scientific Title | The impact of nutrition education during lunchtime on the quality of life of primary school children. |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/07/17 23:16:46 |
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Basic information
Public title
The impact of nutrition education during lunchtime on the mental and physical health of primary school children.
Acronym
Nutrition education and children's quality of life
Scientific Title
The impact of nutrition education during lunchtime on the quality of life of primary school children.
Scientific Title:Acronym
Nutrition education and children's quality of life
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement nutrition education for primary school children dring lunchtime to encourage information sharing with parents and evaluate its impact on children's quality of life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of life
Key secondary outcomes
Children's interest in school lunches, Parent-child conversations
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
Ask students to watch videos on the subject of school lunches in the classroom during lunchtime; four sessions of approximately five minutes per video will be conducted. Quiz the children each time, distribute materials summarising the main points of the day's video and encourage them to share the topic by quizzing their parents at home.
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
| 7 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Grade 2 and 5 schoolchildren from cooperating primary schools
Key exclusion criteria
Persons who have failed to obtain parental consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | YUKI |
| Middle name | |
| Last name | TADA |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science, Faculty of Applied Bioscience
Zip code
156-8502
Address
1-1-1 Sakuragaoka, Setagaya, Tokyo, Japan
TEL
03-5477-2670
y3tada@nodai.ac.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | TADA |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science, Faculty of Applied Bioscience
Zip code
156-8502
Address
1-1-1 Sakuragaoka, Setagaya, Tokyo, Japan
TEL
03-5477-2670
Homepage URL
y3tada@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Agriculture
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee on Experiments and Investigations Involving Human Subjects
Address
1-1-1 Sakuragaoka, Setagaya, Tokyo, Japan
Tel
03-5477-2532
human@nodai.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 | 09 | Month | 05 | 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 | 17 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 15 | 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 | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066894
