UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060366 |
|---|---|
| Receipt number | R000069030 |
| Scientific Title | Verification of the Effects of Growing Vegetables on the Physical and Mental Health of Children and Their Parents |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/15 15:48:23 |
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Basic information
Public title
Verification of the Effects of Growing Vegetables on the Physical and Mental Health of Children and Their Parents
Acronym
Verification of the Effects of Growing Vegetables on the Physical and Mental Health of Children and Their Parents
Scientific Title
Verification of the Effects of Growing Vegetables on the Physical and Mental Health of Children and Their Parents
Scientific Title:Acronym
Verification of the Effects of Growing Vegetables on the Physical and Mental Health of Children and Their Parents
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of cultivation experiences on the stress levels and estimated vegetable intake of children and their parents.
Basic objectives2
Others
Basic objectives -Others
To evaluate the impact of cultivation experiences on the stress levels and estimated vegetable intake of children and their parents.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Intergroup differences in time-dependent changes (slope) of stress indicator A, stress indicator B, and the stress indicator B/stress indicator A ratio during the intervention period
Key secondary outcomes
- Group differences in longitudinal changes in self-efficacy (children only), stress, mood state (parents only), and vegetable intake level.
- Examining factors influencing intervention effectiveness
- Assessing the relationship between cultivation conditions and mental health indicators within the cultivation group
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
No treatment
Interventions/Control_2
Vegetable cultivation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
As of February 2026, primary school pupils in Year 2 attending primary schools in Otsu City, Kusatsu City, Ritto City, and Moriyama City within Shiga Prefecture, and guardians residing with said pupils.
Key exclusion criteria
1. Individuals who regularly cultivate vegetables
2. Individuals for whom it is difficult to collect the required hair length (1 cm) for measurement
3. Individuals living with family members who routinely cultivate edible plants such as vegetables and fruits
4. Individuals planning extended absences (2 weeks or longer) during the study period
5. Individuals who have undergone hair dyeing, bleaching, or straightening within the past month
6. Individuals with major life events scheduled during the study period (weddings, moving house, childbirth, job transfers, etc.)
7. Individuals who have suffered from or are undergoing treatment for the following conditions within one year prior to the trial start date: Cushing's
syndrome, Addison's disease, thyroid disorders, diabetes mellitus, chronic kidney disease, nephrotic syndrome, malignant tumours, depression, bipolar disorder, schizophrenia, post-traumatic stress disorder, stroke, heart failure, coronary artery disease, asthma, peripheral arterial disease, ulcerative colitis, Crohn's disease, hospitalisation (within the past year), surgery (within the past year), tuberculosis
8. Any other person who is deemed inappropriate by the principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
3292762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Shigenori_Suzuki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Sekiya |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
3292762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Homepage URL
Mihoko_Sekiya@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Eve Care Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
3-21-1, F tower, Hamacho, Nihonbashi, Chuo-ku, Tokyo, Japan
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
株式会社イヴケア(滋賀県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 15 | 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 | 12 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069030
