UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053094 |
|---|---|
| Receipt number | R000060588 |
| Scientific Title | Evaluation of self-care promotion approach in community-dwelling healthy subjects |
| Date of disclosure of the study information | 2024/01/20 |
| Last modified on | 2024/06/12 17:55:14 |
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Basic information
Public title
Evaluation of self-care promotion approach in community-dwelling healthy subjects
Acronym
Evaluation of self-care promotion approach
Scientific Title
Evaluation of self-care promotion approach in community-dwelling healthy subjects
Scientific Title:Acronym
Evaluation of self-care promotion approach
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if the changes in health behavior through self-monitoring of meals and physical activity affect health outcomes including muscle mass and strength in community-dwelling healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle mass, muscle strength
Key secondary outcomes
Anthropometry
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
Self-monitoring of physical activity with a wearable device and the intake of a variety of food groups for 4 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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese men and women aged between 40 and 70 years old
Key exclusion criteria
1. Persons under medication for diabetes, kidney diseases, or cardiovascular diseases
2. Persons using implantable medical devices such as pacemakers
3. Persons with joint pain or arthritis in legs and/or hip joint
4. Persons supervised not to exercise
5. Persons unable to use a wearable device and application software by a smart phone
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshinao |
| Middle name | |
| Last name | Goda |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
TEL
054-264-5830
gouda@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Toshinao |
| Middle name | |
| Last name | Goda |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
TEL
054-264-5830
Homepage URL
gouda@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Shizuoka city
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
Research ethics committee of the University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
Tel
054-264-5102
tyous10@u-shizuoka-ken.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
静岡市地域福祉共生センター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 20 | 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
15
Results
During the 4-week health challenge project, the score of food selection variability was significantly elevated, and more time was spent for physical activity. The indices of physical strength as estimated by 2-step test and timed up and go test were significantly improved during the health challenge period.
Results date posted
| 2024 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060588
