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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046226
Receipt No. 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 2021/11/30

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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 Kyusyu 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
Email nishikitani.mariko.585@m.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Mariko
Middle name
Last name Nishikitani
Organization Kyusyu 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
Email nishikitani.mariko.585@m.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

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
Email byskenkyu@jimu.kyushu-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 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 Preinitiation
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
2021 Year 11 Month 30 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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