UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044176 |
|---|---|
| Receipt number | 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 17:05:45 |
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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
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
n-rena.ohcw@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050336
