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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044176
Receipt No. R000050336
Scientific Title Development and evaluation of an eating support manual for children with intellectual disabilities
Date of disclosure of the study information 2021/05/11
Last modified on 2021/05/11

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Basic information
Public title Development and evaluation of an eating support manual for children with intellectual disabilities
Acronym Development and evaluation of an eating support manual for CWID
Scientific Title Development and evaluation of an eating support manual for children with intellectual disabilities
Scientific Title:Acronym Development and evaluation of an eating support manual for CWID
Region
Japan

Condition
Condition children with intellectual disabilities
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop a manual that is specifically effective for "independent eating" and to provide its dissemination and awareness-raising activities to parents, teachers, and other related facilities and users in community.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A dental hygienist will evaluate the eating behavior of all 280 children. Every 3 months, school records and interviews with teachers and parents will be conducted and evaluated (12 times in total). In addition, every 6 months, a dental hygienist will observe and evaluate the eating behavior of all children (6 times in total). The observation items are as following.
a. Eating Observations: Posture, presence or absence of eating behavior problems (fast eating, rounding, food selectivity, etc.)
b. School health check: oral examination. Gathering information from physical examination: oral information, height and weight.
c. Observation of school lunch records and interviews with teachers: eating patterns, meal times, eating utensils.
d.Other things noticed (teeth alignment, etc.)
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
Maneuver
Interventions/Control_1 Based on the school dentist's diagnosis, the dental hygienist gives feedback and guidance to the parents and teachers based on the observations of the children's eating behavior, and evaluates the degree of improvement.
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
6 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All 280 children enrolled in special support schools for the mentally handicapped (elementary, junior high, and high schools), their guardians, and teachers.
Key exclusion criteria None of the above
Target sample size 280

Research contact person
Name of lead principal investigator
1st name Rena
Middle name
Last name Hidaka
Organization Tokyo Medical and Dental University
Division name Department of Oral Health Sciences for Community Welfare
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-4969
Email n-rena.ohcw@tmd.ac.jp

Public contact
Name of contact person
1st name Rena
Middle name
Last name Hidaka
Organization Tokyo Medical and Dental University
Division name Department of Oral Health Sciences for Community Welfare
Zip code 113-8510
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 0358034969
Homepage URL
Email n-rena.ohcw@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Medical and Dental University ethics commity
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel 0358035404
Email d-hyoka.adm@tmd.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 05 Month 11 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
2021 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2021 Year 10 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 11 Day
Last modified on
2021 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050336

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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