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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047762
Receipt No. 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 2022/06/17

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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
4 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
Email 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
Email ym_ishikawa@cc.utsunomiya-u.ac.jp

Sponsor
Institute Utsunomiya University
Institute
Department

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
Email 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
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 No longer recruiting
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
2022 Year 06 Month 17 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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