UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051677 |
|---|---|
| Receipt number | R000058568 |
| Scientific Title | Research on improving the effectiveness of health guidance using personalized technology |
| Date of disclosure of the study information | 2023/07/21 |
| Last modified on | 2023/07/26 14:55:53 |
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Basic information
Public title
Research on improving the effectiveness of health guidance using personalized technology
Acronym
Research on improving the effectiveness of health guidance using personalized technology
Scientific Title
Research on improving the effectiveness of health guidance using personalized technology
Scientific Title:Acronym
Research on improving the effectiveness of health guidance using personalized technology
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of personalized support in health guidance services
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BMI, abdominal circumference
Key secondary outcomes
HbA1c, systolic blood pressure, diastolic blood pressure, triglycerides, HDLC, LDLC, non-HDLC, fasting blood suga, GOT, GPT, gamma GTP. satisfaction with health guidance services and motivation to improve lifestyle.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Using the results of group judgments obtained through questionnaire data on personal characteristics, health counselors adjust the type of information provided to encourage health behavior, the content of advice, the setting of behavioral goals, and the method of communicating such information according to the characteristics of the group.
Interventions/Control_2
Provide specific health guidance without utilizing the group judgment results.
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants will be those who have been registered as persons eligible for specific health guidance based on the results of health examinations conducted by the health insurance association to which the subject belongs, and who have indicated their willingness to participate in the research.
Key exclusion criteria
Those who have not indicated their willingness to participate in the research.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Kimura |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
1-1-1 Higashi, Tsukuba City, Ibaraki
TEL
029-861-6001
kenta.kimura@aist.go.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Kimura |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
1-1-1 Higashi, Tsukuba City, Ibaraki
TEL
029-861-6001
Homepage URL
kenta.kimura@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
Sompo Holdings, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sompo Health Support Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital institutional review board
Address
Toranomon 2-2-2, Minato-ku, Tokyo
Tel
03-3588-1111
chiken-jim@toranomon.gr.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 | 07 | 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
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 | 05 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | 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 | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058568
| 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 |
