UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047762 |
|---|---|
| Receipt number | R000054438 |
| Scientific Title | A Study on Changes in Behavior and Cognition of Parents and Children by "Storytime (Sharing and Playing with the Context of Picture Books)" Using Picture Books of Vegetables and Fruits |
| Date of disclosure of the study information | 2022/05/16 |
| Last modified on | 2023/04/13 08:56:28 |
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Basic information
Public title
A Study on Changes in Behavior and Cognition of Parents and Children by "Storytime (Sharing and Playing with the Context of Picture Books)" Using Picture Books of Vegetables and Fruits
Acronym
A Study on Changes in Behavior and Cognition of Parents and Children by "Storytime (Sharing and Playing with the Context of Picture Books)" Using Picture Books of Vegetables and Fruits
Scientific Title
A Study on Changes in Behavior and Cognition of Parents and Children by "Storytime (Sharing and Playing with the Context of Picture Books)" Using Picture Books of Vegetables and Fruits
Scientific Title:Acronym
A Study on Changes in Behavior and Cognition of Parents and Children by "Storytime (Sharing and Playing with the Context of Picture Books)" Using Picture Books of Vegetables and Fruits
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether reading and playing about vegetables enhances parents' and children's orientation toward vegetables
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of hemoglobin levels in the frontal lobe
Behavioral observation in picture books and play
Questionnaires and interviews (images of vegetables, behavior change after picture books and play)
Key secondary outcomes
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
Storytime
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
| 3 | months-old | <= |
Age-upper limit
| 6 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Parents and children with a child between 4 and 6 months of age
2) The research subject himself/herself and a surrogate who has given his/her free and voluntary consent
Key exclusion criteria
1) Those who have an abnormality found during the perinatal period or delivery
2) The preterm infant or child has an obvious disease or developmental abnormality
3) The eligible mother has an underlying medical or psychiatric condition
4) Mother or child with documented problems communicating in Japanese
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | ISHIKAWA |
Organization
Utsunomiya University
Division name
Cooperative Faculty of Education
Zip code
321-8505
Address
350 Mine-Machi Utunomiya, Tochigi
TEL
028-649-5349
ym_ishikawa@cc.utsunomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | ISHIKAWA |
Organization
Utsunomiya University
Division name
Cooperative Faculty of Education
Zip code
321-8505
Address
350 Mine-Machi Utunomiya, Tochigi
TEL
028-649-5349
Homepage URL
ym_ishikawa@cc.utsunomiya-u.ac.jp
Sponsor or person
Institute
Utsunomiya University
Institute
Department
Personal name
Funding Source
Organization
Kagome Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
KAGOME CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Procedures concerning Research with Human Subjects
Address
350 Mine-Machi Utunomiya Tochigi , Research Cooperation and Industry-University Collaboration Division, Academic Research Department, Utsunomiy University
Tel
028-649-5105
kensui@miya.jm.utsunomiya-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
那須塩原市図書館みるる（栃木県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 16 | 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
9
Results
As for the mothers, there was a trend toward an increase in orientation toward vegetables with Storytime, but no data were available for the children because they were still too young.
Results date posted
| 2023 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Nothing
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054438
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
