UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051599 |
|---|---|
| Receipt number | R000058866 |
| Scientific Title | Encouragement to increase vegetable intake using an equipment to measure skin carotenoid levels -Complex approaches to suppressing eye damage in children and creating mechanisms that promote good behavior- |
| Date of disclosure of the study information | 2023/07/13 |
| Last modified on | 2023/07/13 09:00:36 |
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Basic information
Public title
Encouragement to increase vegetable intake using an equipment to measure skin carotenoid levels -Complex approaches to suppressing eye damage in children and creating mechanisms that promote good behavior-
Acronym
Encouragement to increase vegetable intake using an equipment to measure skin carotenoid levels -Complex approaches to suppressing eye damage in children and creating mechanisms that promote good behavior-
Scientific Title
Encouragement to increase vegetable intake using an equipment to measure skin carotenoid levels -Complex approaches to suppressing eye damage in children and creating mechanisms that promote good behavior-
Scientific Title:Acronym
Increase in vegetable intake using the measurement of skin carotenoid levels
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the understanding of own skin carotenoid levels and eye situation after measuring skin carotenoid levels and eye examination among junior high school student
Basic objectives2
Others
Basic objectives -Others
To investigate the change of good health behavior after measuring skin carotenoid levels and eye examination among junior high school student
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
skin carotenoid level
Key secondary outcomes
vegetable intake
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
nutrition and healthy lifestyle education
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
| 12 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students are enrolled in this study only when their parent agree to participate in this study and submit signed consent form.
Key exclusion criteria
none
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Nozue |
Organization
Tokoha University
Division name
Faculty of Health Promotion Sciences
Zip code
431-2102
Address
1230 Miyakoda-cho, Kita-ku, Hamamatsu-shi, Shizuoka-ken
TEL
81-53-428-6739
mnozue@hm.tokoha-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Nozue |
Organization
Tokoha University
Division name
Faculty of Health Promotion Sciences
Zip code
431-2102
Address
1230 Miyakoda-cho, Kita-ku, Hamamatsu-shi, Shizuoka-ken
TEL
81-53-428-6739
Homepage URL
mnozue@hm.tokoha-u.ac.jp
Sponsor or person
Institute
Tokoha University
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seirei Hamamatsu General Hospital, Hamamatsu University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokoha Univerity
Address
1230 Miyakoda-cho, Kita-ku, Hamamatsu-shi, Shizuoka-ken
Tel
81-53-428-6739
y-mizutani@hm.tokoha-u.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 | 07 | Month | 13 | 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
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 13 | 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
| 2023 | Year | 07 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058866
