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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044427
Receipt No. R000050752
Scientific Title Objective evaluation of chewing ability and mental and physical health of children and elucidation of the correlation between them.
Date of disclosure of the study information 2021/06/04
Last modified on 2021/06/04

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Basic information
Public title Relationship between children's masticatory ability and physical and mental health status.
Acronym Relationship between children's masticatory ability and physical and mental health status.
Scientific Title Objective evaluation of chewing ability and mental and physical health of children and elucidation of the correlation between them.
Scientific Title:Acronym Objective evaluation of chewing ability and mental and physical health of children and elucidation of the correlation between them.
Region
Japan

Condition
Condition Healthy children and adults
Classification by specialty
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate habitual ability of chewing objectively and examine the relationship among chewing ability, mental and physical health and other factors.
Basic objectives2 Others
Basic objectives -Others relationship
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Subjective physical and mental health (DSRS-C, KINDL, SDQ)
Key secondary outcomes Anthropometry (height, weight)

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
10 years-old <=
Age-upper limit
11 years-old >=
Gender Male and Female
Key inclusion criteria 5th grade elementary school students and their parents.
Obtained written informed consent before the participation.
Key exclusion criteria Children who are difficult to chew gum.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Toshiko
Middle name
Last name Kuwano
Organization University of Shizuoka
Division name School of Food and Nutritional Sciences
Zip code 422-8526
Address 52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, Japan
TEL 054-264-5513
Email kuwano@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name Toshiko
Middle name
Last name Kuwano
Organization University of Shizuoka
Division name School of Food and Nutritional Sciences
Zip code 422-8526
Address 52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, Japan
TEL 054-264-5513
Homepage URL
Email kuwano@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of the University of Shizuoka
Address 52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, Japan
Tel 054-264-5103
Email tyous10@u-shizuoka-ken.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
2021 Year 06 Month 04 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 07 Month 22 Day
Date of IRB
2020 Year 08 Month 07 Day
Anticipated trial start date
2021 Year 07 Month 01 Day
Last follow-up date
2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study
Evaluate habitual ability of chewing objectively and examine the relationship among chewing ability, mental and physical health and other factors.

Management information
Registered date
2021 Year 06 Month 04 Day
Last modified on
2021 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050752

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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