UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029655 |
|---|---|
| Receipt number | R000033887 |
| Scientific Title | Investigation about nutritional education for the utilization by special labeling diet |
| Date of disclosure of the study information | 2017/10/22 |
| Last modified on | 2017/10/22 15:35:07 |
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Basic information
Public title
Investigation about nutritional education for the utilization by special labeling diet
Acronym
Investigation about nutritional education for the utilization by special labeling diet
Scientific Title
Investigation about nutritional education for the utilization by special labeling diet
Scientific Title:Acronym
Investigation about nutritional education for the utilization by special labeling diet
Region
| Japan |
Condition
Condition
inadequate nutrition
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of the nutritional education technique for which a nutritional special label diet is used.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Effective educational method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Study meeting by a professional of nutrition
Interventions/Control_2
Study meeting by a non-professional of nutrition
Interventions/Control_3
Self study used by educational medium
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The person who can take orally.
Key exclusion criteria
The person who can not take orally.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Takahashi |
Organization
Tokushima University
Division name
Department of Preventive Enviroment and Nutrition
Zip code
Address
Kuramoto-cho 3-18-15, Tokushima City, Tokushima
TEL
088-633-9428
akiratak@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Takahashi |
Organization
Tokushima University
Division name
Department of Preventive Enviroment and Nutrition
Zip code
Address
Kuramoto-cho 3-18-15, Tokushima City, Tokushima
TEL
088-633-9428
Homepage URL
akiratak@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima 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
Address
Tel
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
| 2017 | Year | 10 | Month | 22 | 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
| 2017 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 22 | Day |
Last modified on
| 2017 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033887
