UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051393 |
|---|---|
| Receipt number | R000056092 |
| Scientific Title | Effectiveness of a project to promote health by creating connections for the elderly |
| Date of disclosure of the study information | 2023/06/21 |
| Last modified on | 2023/06/20 15:08:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness of a project to promote health by creating connections for the elderly
Acronym
Effects of the health promotion project on health-related indicators
Scientific Title
Effectiveness of a project to promote health by creating connections for the elderly
Scientific Title:Acronym
Effects of the health promotion project on health-related indicators
Region
| Japan |
Condition
Condition
Subjective well-being
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects on subjective well-being by maintaining healthy exercise habits, eating habits, and cognitive functions through "connection (social participation)".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective well-being
Key secondary outcomes
Physical activity and physical function
Dietary habits
Social activity and psychosocial function
Information and communication technology usage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
People who either participate in online exercise, nutrition, and communication programs, visit community spaces, or attend community events such as workshops and smartphone classes.
Interventions/Control_2
Control
People who neither participate in online exercise, nutrition, and communication programs, visit community spaces, nor attend community events such as workshops and smartphone classes.
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
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 65-84 years old living in Chofu City, Tokyo.
Key exclusion criteria
Certified as requiring assistance or nursing care.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Ohkawara |
Organization
The University of Electro-Communications
Division name
Graduate School of Informatics and Engineering
Zip code
1828585
Address
1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan
TEL
042-443-5584
ohkawara_kazunori@e-one.uec.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Ohkawara |
Organization
The University of Electro-Communications
Division name
Graduate School of Informatics and Engineering
Zip code
1828585
Address
1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan
TEL
042-443-5584
Homepage URL
ohkawara_kazunori@e-one.uec.ac.jp
Sponsor or person
Institute
The University of Electro-Communications
Institute
Department
Personal name
Funding Source
Organization
Chofu city, Tokyo
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Labor and safty office, Personnel and labor affairs office, The University of Electro-Communications
Address
1-5-1 Chofugaoka, Chofu, Tokyo, 182-8585, Japan
Tel
042-443-5028
human-ethics@office.uec.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 | 06 | Month | 21 | 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
3742
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 10 | 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
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | 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=R000056092
