UMIN-CTR Clinical Trial

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