UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052707 |
|---|---|
| Receipt number | R000060132 |
| Scientific Title | Impact of Notifications on Nutrition, Sleep, and Physical activity on Intellectual function and muscle mass in OldeR adults (INSPIOR) |
| Date of disclosure of the study information | 2023/11/07 |
| Last modified on | 2023/12/01 11:58:32 |
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Basic information
Public title
Impact of Notifications on Nutrition, Sleep, and Physical activity on Intellectual function and muscle mass in OldeR adults (INSPIOR)
Acronym
INSPIOR
Scientific Title
Impact of Notifications on Nutrition, Sleep, and Physical activity on Intellectual function and muscle mass in OldeR adults (INSPIOR)
Scientific Title:Acronym
INSPIOR
Region
| Japan |
Condition
Condition
Healthy Older Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Promotion of health status of the elderly by wearing wearable devices (smartwatches) and health guidance (alerts) from dedicated apps
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in health status (intellectual and physical functions) after 6 months of wear
Key secondary outcomes
Improvement in health habits (Nutrition, Exercise and Sleep) after 6 months of wear
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Provide personalized lifestyle guidance (exercise, sleep and diet habits) and protein-fortified foods through a dedicated app
Interventions/Control_2
Routine Care
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
| 92 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Order Adults in mildly declining health status
Key exclusion criteria
Order Adults in good health
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Hisatsune |
Organization
University of Tokyo
Division name
GSFS
Zip code
2778562
Address
5-1-5 Kashiwanoha, Kashiwa
TEL
0471363632
hisatsune@edu.k.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Hisatsune |
Organization
UTokyo
Division name
GSFS
Zip code
2778562
Address
5-1-5 Kashiwanoha, Kashiwa
TEL
0471363632
Homepage URL
hisatsune@edu.k.u-tokyo.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Google LLC
Name of secondary funder(s)
IRB Contact (For public release)
Organization
GSFS, UTokyo
Address
5-1-5 Kashiwanoha, Kashiwa
Tel
0471363632
hisatsune@edu.k.u-tokyo.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 | 11 | Month | 07 | 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 | 11 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 11 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060132
