UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046226 |
|---|---|
| Receipt number | R000052754 |
| Scientific Title | Impact of active use of SNS and diet recording app on the health behavior of middle-aged and elderly people |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2024/02/02 03:39:09 |
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Basic information
Public title
Impact of active use of SNS and diet recording app on the health behavior of middle-aged and elderly people
Acronym
Impact of active use of SNS and diet recording app on the health behavior of middle-aged and elderly people
Scientific Title
Impact of active use of SNS and diet recording app on the health behavior of middle-aged and elderly people
Scientific Title:Acronym
Impact of active use of SNS and diet recording app on the health behavior of middle-aged and elderly people
Region
| Japan |
Condition
Condition
Social isolation, loneliness
Classification by specialty
| Psychosomatic Internal Medicine | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the impact of ICT utilization of social networks on elderly people's interaction and health by mitigating isolation and loneliness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Decreased isolation and/or loneliness scores
Key secondary outcomes
Improving health
Increased motivation for activity
Improvement of social-psychological state
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Study participants use a group chat or diet recording apps using a smartphone or tablet device for four weeks of intervention. Participants are encouraged to share active comments at least once a day with other participants
Interventions/Control_2
Study participants use a group chat or diet recording apps using a smartphone or tablet device for four weeks of placebo assignment. Participants read only a message from researchers and neither share other participants' active comments nor send their comments.
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The person who meets all conditions follows:
(1) Adults whose age are 55 years old and older
(2) is healthy enough without support or care from others
(3) lives independently at the regional communities
(4) can understand the research protocol and make consent for study participation.
(5) can understand and use standard Japanese.
(6) has smartphones or tablets to use daily.
(7) can show consent before the research starts.
Key exclusion criteria
The person who meets any of the conditions follows:
(1) lives in special institutions ready for the elderly.
(2) is decided as not eligible by researchers.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Nishikitani |
Organization
Kyushu University Hospital
Division name
Medical Information Center
Zip code
812-8582
Address
Collabo station II-705, 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6475
nishikitani.mariko.105@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Nishikitani |
Organization
Kyushu University Hospital
Division name
Medical Information Center
Zip code
812-8582
Address
Collabo station II-705, 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6475
Homepage URL
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000052754
nishikitani.mariko.105@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
The Tojuro Iijima Foundation for Food Science and Technology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
St. Catherine University
A public interest incorporated association Fukuoka-ken Koreisha Noryoku Katsuyo Center
Name of secondary funder(s)
JSPS KAKENHI
IRB Contact (For public release)
Organization
Kyushu University Hospital IRB
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
21-07
Org. issuing International ID_1
St. Catherine IRB
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院（福岡県） Kyushu University Hospital (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052754
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
