UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046936 |
|---|---|
| Receipt number | R000053552 |
| Scientific Title | Study on effectiveness of digital peer support mobile application "Minchalle" on behavior change: Mirai-Minchalle study |
| Date of disclosure of the study information | 2022/02/24 |
| Last modified on | 2024/02/19 10:50:41 |
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Basic information
Public title
Effectiveness of digital peer support mobile application for behavior change: Mirai-Minchalle study
Acronym
Effectiveness of digital peer support mobile application for behavior change: Mirai-Minchalle study
Scientific Title
Study on effectiveness of digital peer support mobile application "Minchalle" on behavior change: Mirai-Minchalle study
Scientific Title:Acronym
Study on effectiveness of digital peer support mobile application "Minchalle" on behavior change: Mirai-Minchalle study
Region
| Japan |
Condition
Condition
Lifestyle related diseases
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether healthy behavior continues by using the digital peer support mobile application "Minchalle" in the general population
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-month continuation rate
Key secondary outcomes
Changes in health-related data collected in this study and the Kanagawa Prefecture Mirai-MEBYO Cohort Study, such as changes in physical activities, changes in lifestyle, and changes in ME-BYO INDEX evaluate by comparison between groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
To use digital peer support mobile application Minchalle for 6 months
Interventions/Control_2
traditional health care
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have smartphone and are able to manipulate it
Key exclusion criteria
Those who are unable to make a decision and sign the informed consent document on their own
Those who have difficulty in filling in the questionnaire on their own
Those who face challenging in communication in Japanese
Those who are unable to walk on their own without help
Those who are supposed to have adverse physical or mental effect by the intervention and are regarded inappropriate to be a participant
Those who have a habit of taking regular exercise (doing 30 minute moderate to vigorous exercise a day and twice a week and this habit has lasted more than one year OR doing more than one hour walking or relevant physical exercise everyday)
Those who have experience to participate in ME-BYO living labo projects initiated by Kanagawa Prefecture
Those who have participated in other exercise intervention programs
Those who have used Minchalle within the past 6 months
Those who are an expecting mother
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Narimatsu |
Organization
Kanagawa University of Human Services
Division name
Graduate School of Health Innovation
Zip code
210-0821
Address
Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-589-8100
hiroto-narimatsu@umin.org
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Narimatsu |
Organization
Kanagawa University of Human Services
Division name
Graduate School of Health Innovation
Zip code
210-0821
Address
Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
044-589-8100
Homepage URL
hiroto-narimatsu@umin.org
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa University of Human Services Graduate School of Health Innovation
Address
Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa
Tel
044-589-8100
health-innovation@kuhs.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
| 2022 | Year | 02 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 02 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053552
