UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050182 |
|---|---|
| Receipt number | R000057158 |
| Scientific Title | Development of a Nutrition Education Class Unit to Promote Vegetable Intake Behavior at School Lunch and Development of a Program Integrating Lunch Instruction and its Effectiveness Verification |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/12/12 22:20:21 |
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Basic information
Public title
Development of a Nutrition Education Class Unit to Promote Vegetable Intake Behavior at School Lunch and Development of a Program Integrating Lunch Instruction and its Effectiveness Verification
Acronym
Development of a Nutrition Education Class Unit to Promote Vegetable Intake Behavior at School Lunch and Development of a Program Integrating Lunch Instruction and its Effectiveness Verification
Scientific Title
Development of a Nutrition Education Class Unit to Promote Vegetable Intake Behavior at School Lunch and Development of a Program Integrating Lunch Instruction and its Effectiveness Verification
Scientific Title:Acronym
Development of a Nutrition Education Class Unit to Promote Vegetable Intake Behavior at School Lunch and Development of a Program Integrating Lunch Instruction and its Effectiveness Verification
Region
| Japan |
Condition
Condition
Healthy Children
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to improve children's vegetable intake by developing a program that integrates a nutrition education unit that promotes vegetable intake behavior in school lunches and school lunch instruction, utilizing nudges used in behavioral economics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vegetable intake in school lunches
Survey period: pre-survey, post-survey (12 months later)
Key secondary outcomes
Estimated vegetable intake
Frequency of completing school lunch (by food category)
Frequency of eating school lunch (by food category)
Types of vegetables that are usually eaten frequently
Types of vegetables that are tasty
Types of vegetables that are not good for you
Taste of the vegetables themselves
To know how to season vegetables to make them taste good.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Nutrition education class (20 hours): In accordance with the Courses of Study, nutrition education will be conducted in the integrated learning time. (1) The school lunch, which is familiar to children, will be used as a starting point to grasp the state of vegetable intake. Veg-Check R will be used for this purpose. By visualizing invisible nutrients, children will become aware of the nutrients in the vegetables they take into their bodies. From there, we will develop a class in which the students will be able to look at various issues connected to society through vegetables, such as how they work in the body, the types and amounts of nutrients contained in vegetables, how they are grown, the amount of vegetables grown in Japan, and the differences in the types that can be grown depending on the region and climate, and through their own vegetable intake behavior, and develop their interest in these issues. In this context, by actually growing vegetables, we will further connect not only the knowledge of vegetables but also the experience. (3) Each student grows one tomato seedling as part of the vegetable cultivation. Next, the students will prepare their own recipes for how to eat the vegetables they have grown, focusing on seasonings that bring out the flavor of the ingredients themselves (cooking practice). (3) The recipes are served at school lunch, and the children in the lower grades try them and vote for their favorites.
School lunch instruction program (15 days): Nudges will be used in the preparation, serving, and eating of school lunches. (1) Hold "Let's Eat Vegetables Deliciously Week" using delicious vegetable menus designed by the students themselves. (2) Review the serving size of side dishes (default). (iii) Seeing classmates eating vegetables will motivate them to eat them as well (tonal effect).
Interventions/Control_2
School lunch instruction program (15 days): Use nudges in preparation, serving, and eating during lunch time. (1) Hold "Let's Eat Vegetables Deliciously Week" using delicious vegetable menus created by children in other classes. (2) Review the serving size of side dishes (default). (iii) Seeing classmates eating vegetables will motivate them to eat them as well (tonal effect).
Interventions/Control_3
Normal school lunch guidance
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
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The students who are enrolled at Chiba University Elementary School
2. The students and their parents/guardian who have agreed to participate in this study
3.The participants who attend all the survey
Key exclusion criteria
1. The students who are continuously absent from school due to school refusal etc.
2.The students who are diffi cult to participatethe survey due to health reasons
3.Those who do not have suffi cient ability in Japanese to participate in this survey
Target sample size
101
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
KAGOME CO.,LTD.
Diet & Well-being Research Department Innovation Division
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
KAGOME CO.,LTD.
Diet & Well-being Research Department Innovation Division
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa Nutrition University Research ReviewCommittee
Address
3-9-21 Chiyoda Sakado Saitama 350-0288 Japan
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
| 2023 | Year | 04 | 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
92
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057158
