UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051107 |
|---|---|
| Receipt number | R000058257 |
| Scientific Title | Prevention of frailty using the online application "Baransu-Nikki" |
| Date of disclosure of the study information | 2023/05/19 |
| Last modified on | 2023/05/19 14:57:31 |
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Basic information
Public title
Prevention of frailty using the online application "Baransu-Nikki"
Acronym
Prevention of frailty using the online application "Baransu-Nikki"
Scientific Title
Prevention of frailty using the online application "Baransu-Nikki"
Scientific Title:Acronym
Prevention of frailty using an online application
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study is to examine the effectiveness of using the online application "Baransu-Nikki" and combined program of nutrition and moderate exercise on improvement of dietary variety score(DVS) leading to frailty prevention in community dwelling older adults.
Basic objectives2
Others
Basic objectives -Others
Another purpose is to examine the feasibility of using the online application in nutritional education to older adults
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Dietary variety score(DVS)
Key secondary outcomes
Kaigo-Yobo Check List, food and nutrition intakes using the BDHQ, body composition(fat-free mass and fat mass) with InBody770, physical performance(grip strength, five-repetition sit-to-stand test), subjective health, WHO-5, usability of the application
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Recording all foods consumed each day among 10 food items on the top screen of the online application "Baransu-Nikki", in principle every two weeks during 3-month intervention. And also, participation in the combined program of nutritional advise with moderate exercise which takes place every two weeks, each two hours duration.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Holder of smartphone which can be downloaded the application "Baransu-Nikki" and those who do not receive supervised nutritional advise in clinic or hospital.
Key exclusion criteria
Persons having possible difficulty in repeated participation due to serious physical or mental problems.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Shinkai |
Organization
Kagawa Nutrition University
Division name
Community Health and Gerontology
Zip code
350-0288
Address
3-9-21 Chiyoda, Sakado-shi, Saitama, Japan
TEL
049-282-3464
shinkai.shoji@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Lulu |
| Middle name | |
| Last name | Akao |
Organization
Kagawa Nutrition University
Division name
Community Health and Gerontology
Zip code
350-0288
Address
3-9-21 Chiyoda, Sakado-shi, Saitama, Japan
TEL
049-282-3464
Homepage URL
ara221@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Shoji Shinkai
Funding Source
Organization
The Nisshin OilliO Group, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa Nutrition University Research Support Division
Address
3-9-21 Chiyoda, Sakado-shi, Saitama, Japan
Tel
049-282-1353
kenshien@eiyo.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 | 19 | 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
29
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
| 2023 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 05 | 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 | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058257
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