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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041257
Receipt No. R000047102
Scientific Title The Relation of Breast-feeding and Eating Behavior from 9-month-olds to 47-month-olds children.
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/30

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Basic information
Public title The Relation of Breast-feeding and Eating Behavior from 9-month-olds to 47-month-olds children.
Acronym The Relation of Breast-feeding and Eating Behavior in toddlers and young children.
Scientific Title The Relation of Breast-feeding and Eating Behavior from 9-month-olds to 47-month-olds children.
Scientific Title:Acronym The Relation of Breast-feeding and Eating Behavior in toddlers and young children.
Region
Japan

Condition
Condition None (Healthy children)
Classification by specialty
Not applicable Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To Clarify the percentage of a breast-feeding and eating behavior in children who are weaning or already had weaned.
2. To find some factors that a breast-feeding style is affected eating behavior.

Basic objectives2 Others
Basic objectives -Others To consider the suitable usage of a bottle and nipple in infants and toddlers, and the transition from breast-feeding to weaning.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will conduct the online survey that hear from mothers about their children's feeding condition and style, eating condition or something.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
9 months-old <=
Age-upper limit
47 months-old >=
Gender Male and Female
Key inclusion criteria 1. Children who are breast-feeding, bottle-feeding, mixed, or already weaning.
2. Children who eat solid food including baby food from their mouth.
3. Mothers who agree to join our online survey.
Key exclusion criteria 1. Children who are delay to motor development.
2. Children who are only breast-milk or artificial milk.(ever have not eaten baby food or solid food)
3. Children who are tube feeding.
Target sample size 900

Research contact person
Name of lead principal investigator
1st name Sumiko
Middle name
Last name Kuroishi
Organization Pigeon Corporation
Division name Research and Development DIV. Breast-feeding Lab.
Zip code 300-2495
Address 6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki 300-2495, Japan
TEL 0297-52-6532
Email sumiko.kuroishi@pigeon.com

Public contact
Name of contact person
1st name Yoshimi
Middle name
Last name Osugi
Organization Pigeon Corporation
Division name Research and Development DIV. Breast-feeding Lab.
Zip code 300-2495
Address 6-20-4, Kinunodai, Tsukubamirai-shi, Ibaraki 300-2495, Japan
TEL 0297-52-6532
Homepage URL
Email yoshimi.oosugi@pigeon.com

Sponsor
Institute Pigeon Corporation, and Macromill, Inc.
Institute
Department

Funding Source
Organization Pigeon Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Macromill, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ueno-Asagao Clinic Ethical Review Committee
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel 03-6240-1162
Email jimukyoku@tes-h.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 株式会社マクロミル(東京都)/ Macromill, Inc. (Tokyo)

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 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 764
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
2019 Year 12 Month 20 Day
Date of IRB
2019 Year 12 Month 23 Day
Anticipated trial start date
2020 Year 01 Month 17 Day
Last follow-up date
2020 Year 02 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 07 Month 30 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047102

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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