UMIN-CTR Clinical Trial

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

Healthy Children

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Vegetable intake in school lunches
Survey period: pre-survey, post-survey (6 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.

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

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

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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

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

Email

nakanisi@eiyo.ac.jp

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

Email

nakanisi@eiyo.ac.jp

Institute

Kagawa Nutrition University

Institute

Department

Personal name

Organization

KAGOME CO.,LTD.
Diet & Well-being Research Department Innovation Division

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

KAGOME CO.,LTD.
Diet & Well-being Research Department Innovation Division

Name of secondary funder(s)

Organization

Kagawa Nutrition University Research ReviewCommittee

Address

3-9-21 Chiyoda Sakado Saitama 350-0288 Japan

Tel

049-289-6041

Email

kenshien@eiyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

03

Month

31

Day

Date of IRB

Anticipated trial start date

2023

Year

04

Month

15

Day

Last follow-up date

2023

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

01

Month

30

Day

Last modified on

2023

Year

03

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057158