UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044263 |
|---|---|
| Receipt number | R000050550 |
| Scientific Title | Verification of effectiveness of guidance and guidance follow-up using the lifestyle care apps in health guidance |
| Date of disclosure of the study information | 2021/05/20 |
| Last modified on | 2021/05/19 16:31:49 |
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Basic information
Public title
Verification of effectiveness of guidance and guidance follow-up using the lifestyle care apps in health guidance
Acronym
Verification of effectiveness of guidance and guidance follow-up using the lifestyle care apps in health guidance
Scientific Title
Verification of effectiveness of guidance and guidance follow-up using the lifestyle care apps in health guidance
Scientific Title:Acronym
Verification of effectiveness of guidance and guidance follow-up using the lifestyle care apps in health guidance
Region
| Japan |
Condition
Condition
Subjects of Specific Health Guidance
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In addition to evaluating and examining the differences in improvement effects when health guidance provided by professionals is combined with support for lifestyle improvement using applications, we will analyze various parameters, such as the goals set, the status of achievement, and the use of applications, to examine factors for improving improvement effects. In addition, we will analyze various parameters, such as the goals set, achievement status, and application usage, to study the factors for improving the improvement effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in body weight and body composition parameters after 3 and 6 months compared to the initial guidance for each subject
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjects subject to motivational support and using the application
Interventions/Control_2
Subjects subject to motivational support and not using the application.
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1) Subjects of motivational support and active support for specific health guidance at Mitsui Chemicals, Inc.
2) Those who have read and understood the consent explanatory document for this study and have obtained written consent from the individual.
Key exclusion criteria
None in particular
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ikuyo |
| Middle name | |
| Last name | Ichi |
Organization
Ochanomizu University
Division name
Facurty of Core Research
Zip code
112-8610
Address
2-1-1, Otsuka, Bunkyo-ku, Tokyo
TEL
03-5978-5750
ichi.ikuyo@ocha.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Furuoku |
Organization
Habitus Care Inc.
Division name
Operations department
Zip code
105-0012
Address
Seiwa Daimon Building, 1-1-21 Shiba Daimon, Minato-ku, Tokyo
TEL
03-6253-2654
Homepage URL
furuoku@habituscare.co.jp
Sponsor or person
Institute
Ochanomizu University
Institute
Department
Personal name
Funding Source
Organization
Habitus Care Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ochanomizu University Ethics Committee
Address
2-1-1, Otsuka, Bunkyo-ku, Tokyo
Tel
03-5978-5750
ichi.ikuyo@ocha.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
| 2021 | Year | 05 | 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
40
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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 07 | 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 | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050550
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
