UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050535 |
|---|---|
| Receipt number | R000057542 |
| Scientific Title | Effect of Mobile Application-based Dietary advice for older adult with malnutrition and low masticatory function |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2024/04/24 15:35:13 |
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Basic information
Public title
Effect of Mobile Application-based Dietary advice for older adult with malnutrition and low masticatory function
Acronym
Effect of Mobile Application-based Dietary advice for older adult with malnutrition and low masticatory function
Scientific Title
Effect of Mobile Application-based Dietary advice for older adult with malnutrition and low masticatory function
Scientific Title:Acronym
Effect of Mobile Application-based Dietary advice for older adult with malnutrition and low masticatory function
Region
| Japan |
Condition
Condition
Older adult with malnutrition and low masticatory function
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of mobile application-based dietary advice on dietary variety score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dietary Variety Score
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
Uncontrolled
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
Mobile application-based dietary advice for 12 weeks
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
1.Subjects aged 65 years or older
2.Subjects living in Tokyo
3.Subjects with malnutrition or tendency of malnutrition
4.Subjects with low masticatory ability
Key exclusion criteria
1.Subject with dysphagia
2.Subjects who are certified as requiring long-term care
3.Subjects with low cognitive function(MMSE-J score 28 or less)
4.Subjects who has received dietary therapy for any indication (including food allergy)
5.Subjects who cannot use smartphones or tablets
6.Subjects who are judged inappropriate for the study by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Motokawa |
Organization
Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan
TEL
03-3964-3241
kmoto@tmig.or.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Motokawa |
Organization
Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan
Division name
Research Team for Promoting Independence and Mental Health
Zip code
03-3964-3241
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan
TEL
03-3964-3241
Homepage URL
kmoto@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., 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
Institutional review Board, Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan
Tel
03-3964-3241
rinsyoushiken@tmghig.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 | 03 | Month | 10 | 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
27
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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 07 | 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 | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057542
