UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056683 |
|---|---|
| Receipt number | R000064736 |
| Scientific Title | Elucidation of the effect of vegetable cultivation and cooking experiences on the preferences for vegetables among children of kindergarten and elementary school. |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2025/01/06 14:17:07 |
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Basic information
Public title
Elucidation of the effect of vegetable cultivation and cooking experiences on the preferences for vegetables among children of kindergarten and elementary school.
Acronym
Elucidation of the effect of vegetable cultivation and cooking experiences on the preferences for vegetables among children of kindergarten and elementary school.
Scientific Title
Elucidation of the effect of vegetable cultivation and cooking experiences on the preferences for vegetables among children of kindergarten and elementary school.
Scientific Title:Acronym
Elucidation of the effect of vegetable cultivation and cooking experiences on the preferences for vegetables among children of kindergarten and elementary school.
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to obtain exploratory and preliminary data on whether a program combining vegetable cultivation and cooking experiences can improve preference for vegetables and increase vegetable intake of young children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin carotenoid level
Vegetable consumption
Preference for vegetable
Key secondary outcomes
Amount of vegetables provided at home
Skin carotenoid level of the guardians of the study subjects
Indicators of Well-being
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
A program which combines vegetable cultivation and cooking experiences
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
| 4 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children whose guardians have given informed consent to participate in the study and who are enrolled at the 4-year-old class of the Hamakko Kodomoen or at the first grade of the Imatomi Elementary School of Obama City as of February 2025.
Key exclusion criteria
N/A
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Aizawa |
Organization
KAGOME CO.,LTD.
Division name
Health & Wellness Business Department, Business Development Division
Zip code
103-8461
Address
Nihonbashi Hamacho F Tower, 3-21-1 Nihonbashi Hamacho, Chuo-ku, Tokyo
TEL
03-5623-8501
Koichi_Aizawa@kagome.co.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Matsumoto |
Organization
KAGOME CO.,LTD.
Division name
Health & Wellness Business Department, Business Development Division
Zip code
329-2762
Address
17 Nishitoyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Homepage URL
Mai_Matsumoto@kagome.co.jp
Sponsor or person
Institute
KAGOME CO.,LTD.
Obama City, Fukui Prefecture
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO.,LTD.
Obama City, Fukui Prefecture
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Obama City Certified Children's Garden Hamakko Kodomoen
Obama City Imatomi Elementary School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Research Ethics Review Board
Address
Nihonbashi Hamacho F Tower, 3-21-1 Nihonbashi Hamacho, Chuo-ku, Tokyo
Tel
03-5623-8501
IRB@kagome.co.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
小浜市認定こども園浜っ子こども園、小浜市立今富小学校、御食国若狭おばま食文化館（全て福井県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 10 | 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
| 2024 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 30 | 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 | 01 | Month | 10 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064736
