UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054718 |
|---|---|
| Receipt number | R000062529 |
| Scientific Title | The Effect of Frailty Prevention by Registered Dietitians on the Health of Elderly Individuals. |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/06/20 11:17:37 |
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Basic information
Public title
The Effect of Frailty Prevention by Registered Dietitians on the Health of Community-Dwelling Elderly Individuals.
Acronym
The Effect of Frailty Prevention by Registered Dietitians on the Health of Elderly Individuals.
Scientific Title
The Effect of Frailty Prevention by Registered Dietitians on the Health of Elderly Individuals.
Scientific Title:Acronym
The Effect of Frailty Prevention by Registered Dietitians on the Health of Elderly Individuals.
Region
| Japan |
Condition
Condition
Frailty Prevention
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether there have been changes in dietary behavior due to food support for elderly individuals living in the community, conduct surveys or other assessments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grip Strength
Chewing Power
Calf Circumference
Frailty Check
Checking the balance of the diet
Key secondary outcomes
Dietary Knowledge
Feeding Behavior
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
| Food | Behavior,custom |
Interventions/Control_1
Group Instruction
Individual Tutoring
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
User of facility
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Misako |
| Middle name | |
| Last name | Sogawa |
Organization
Shikoku University
Division name
Faculty of Human Life Science, Department of Health and Nutrition
Zip code
7711192
Address
123-1, Ebisuno, Furukawa, ojin-cho, Tokushima, Japan
TEL
088-665-9363
sogawam@shikoku-u.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Inoue |
Organization
The Graduate school of Shikoku university
Division name
Graduate school of Human life science
Zip code
7711192
Address
123-1, Ebisuno, Furukawa, ojin-cho, Tokushima, Japan
TEL
088-665-9363
Homepage URL
naomi12140327@gmail.com
Sponsor or person
Institute
Faculty of Human Life Science, Department of Health and Nutrition, Shikoku University
Institute
Department
Personal name
Misako Sogawa
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shikoku University Research Ethics Review Committee
Address
123-1, Ebisuno, Furukawa, ojin-cho, Tokushima, Japan
Tel
088-665-9909
gakubu-shien@shikoku-u.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
| 2024 | Year | 07 | Month | 01 | 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
| 2024 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 06 | Month | 20 | Day |
Last modified on
| 2024 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062529
