UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049851 |
|---|---|
| Receipt number | R000055385 |
| Scientific Title | A cross sectional study on the anthropometric characteristics and nutrition intake of children with intellectual disabilities in Japan |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/12/21 14:08:10 |
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Basic information
Public title
A cross sectional study on the anthropometric characteristics and nutrition intake of children with intellectual disabilities in Japan
Acronym
A cross sectional study on the anthropometric characteristics and nutrition intake of children with intellectual disabilities in Japan
Scientific Title
A cross sectional study on the anthropometric characteristics and nutrition intake of children with intellectual disabilities in Japan
Scientific Title:Acronym
A cross sectional study on the anthropometric characteristics and nutrition intake of children with intellectual disabilities in Japan
Region
| Japan |
Condition
Condition
Healthy children with intellectual disabilities
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze a frequency distribution of each anthropometric characteristic, and a relationship between anthropometric characteristics and nutrition intake.
Basic objectives2
Others
Basic objectives -Others
Parental psychological factors on the anthropometric characteristics of children with intellectual disabilities also will be analyzed.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
anthropometric characteristics at beginning of September
Key secondary outcomes
nutrition intake during summer holidays
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
| 6 | years-old | <= |
Age-upper limit
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children in elementary school department, school for Special Needs Education
Key exclusion criteria
Children with other disability
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Nishide |
Organization
Ibaraki Christian University
Division name
College of Life Sciences
Zip code
3191295
Address
6-11-1 Omika, Hitachi, Ibaraki
TEL
+81294523215
nishidea@icc.ac.jp
Public contact
Name of contact person
| 1st name | Akemi |
| Middle name | |
| Last name | Nishide |
Organization
Ibaraki Christian University
Division name
College of Life Sciences
Zip code
3191295
Address
6-11-1 Omika, Hitachi, Ibaraki
TEL
+81294523215
Homepage URL
nishidea@icc.ac.jp
Sponsor or person
Institute
Ibaraki Christian University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Christian University
Address
6-11-1Omika,Hitachi,Ibaraki
Tel
+81294523215
rinri2@icc.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-008
Org. issuing International ID_1
Ibaraki Christian University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
茨城キリスト教大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
450
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
All data were from surveys written 2nd Sep,2022-9 to 9th Sep. 2022
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055385
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
