UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042111
Receipt number R000048060
Scientific Title A Survey on the Relationship between toddlers' Activities and Growth (China-Japan International Comparative Study)
Date of disclosure of the study information 2020/11/01
Last modified on 2020/10/14 11:18:55

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Basic information

Public title

A Survey on the Relationship between toddlers' Activities and Growth

Acronym

A Survey on the Relationship between toddlers' Activities and Growth

Scientific Title

A Survey on the Relationship between toddlers' Activities and Growth (China-Japan International Comparative Study)

Scientific Title:Acronym

A Survey on the Relationship between toddlers' Activities and Growth

Region

Japan Asia(except Japan)


Condition

Condition

No condition

Classification by specialty

Not applicable Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A Survey on the Relationship between toddlers' Activities and Growth

Basic objectives2

Others

Basic objectives -Others

A Study on the Relationship between The Activities and Growth of toddler in Japan and China

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Analysis of the relationship between toddler activity and growth, and international comparison between Japan and China.

Key secondary outcomes



Base

Study type

Observational


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

36 months-old <=

Age-upper limit

38 months-old >=

Gender

Male and Female

Key inclusion criteria

China
1.male and female toddlers (36 months to 38 months old), and their mothers
2.toddlers and their mothers living in Shanghai from birth to the present
3.toddlers and their mothers who can come to the test site on a particular day
4.Mothers who can agree to answer questions such as height, weight, educational background, annual income, medical history, disability, size of residence, and medical history of the target toddler

Japan
1.male and female toddlers (36 months to 38 months old), and their mothers
2.toddlers and their mothers living in Japan from birth to the present
3.toddlers and their mothers who can come to the test site on a particular day
4.Mothers who can agree to answer questions such as height, weight, educational background, annual income, medical history, disability, size of residence, and medical history of the target toddler

Key exclusion criteria

1.During the two weeks before going to the test site, the toddler or mother have a fever or respiratory symptoms.
2.During the two weeks before going to the test site, the family living with the toddler and mother have a fever or respiratory symptoms.
3.The toddler and/or mother who judged that a test staff in attendance was unsuitable as a test participant.

Target sample size

6400


Research contact person

Name of lead principal investigator

1st name Yuuko
Middle name
Last name Fukuda

Organization

Kao Corporation

Division name

Sanitary Products Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7561

Email

fukuda.yuuko1@kao.com


Public contact

Name of contact person

1st name Yuuko
Middle name
Last name Fukuda

Organization

Kao Corporation

Division name

Sanitary Products Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7561

Homepage URL


Email

fukuda.yuuko1@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Juntendo University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-7263

Email

morisaki.naoko@kao.com


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

日本:任意の試験会場(東京都)
中国:任意の試験会場(上海)


Other administrative information

Date of disclosure of the study information

2020 Year 11 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


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

2020 Year 09 Month 11 Day

Date of IRB

2020 Year 09 Month 11 Day

Anticipated trial start date

2020 Year 11 Month 01 Day

Last follow-up date

2021 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A Survey on the Relationship between toddlers' Activities and Growth


Management information

Registered date

2020 Year 10 Month 14 Day

Last modified on

2020 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048060


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name