UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050960 |
|---|---|
| Receipt number | R000058088 |
| Scientific Title | Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Parents and Children Using Child Development Support and After-School Day Care Services |
| Date of disclosure of the study information | 2023/05/08 |
| Last modified on | 2023/11/07 17:17:48 |
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Basic information
Public title
Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Parents and Children Using Child Development Support and After-School Day Care Services
Acronym
Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Children with Developmental Disabilities and Their Parents
Scientific Title
Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Parents and Children Using Child Development Support and After-School Day Care Services
Scientific Title:Acronym
Effects on Eating Behavior and Intestinal Environment by Implementation of Nutrition Education Support in Children with Developmental Disabilities and Their Parents
Region
| Japan |
Condition
Condition
Children with developmental disabilities and Down syndrome and their parents
Classification by specialty
| Pediatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the dietary intake, food preferences, and intestinal microflora of children with developmental disabilities and their parents, and to clarify the impact of providing nutrition education support.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate food intake, defecation status, and bowel habits after implementation of nutrition education
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Examine nutrition education support content and implement nutrition education based on the results of the questionnaire survey on food preferences.
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
| 4 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parents and children using child development support and after-school day care services in Niigata City
Key exclusion criteria
Those that ceased to use the facility during the study period.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mizuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, niigata,JAPAN
TEL
+81-25-257-4494
takeuchi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, niigata,JAPAN
TEL
025-257-4494
Homepage URL
takeuchi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, niigata,JAPAN
Tel
025-257-4494
takeuchi@nuhw.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
| 2023 | Year | 05 | Month | 08 | 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
| 2023 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | 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
| 2023 | Year | 04 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058088
| 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 |
