UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039466 |
|---|---|
| Receipt number | R000044999 |
| Scientific Title | A Feasibility Study of the Effects of Lifestyle Modification on Prevention of Diabetes with the Use of a Peer Support Model Habituation App. |
| Date of disclosure of the study information | 2020/02/14 |
| Last modified on | 2020/02/12 17:49:24 |
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Basic information
Public title
A Feasibility Study of the Effects of Lifestyle Modification on Prevention of Diabetes with the Use of a Peer Support Model Habituation App.
Acronym
A Feasibility Study of the Effects of Lifestyle Modification on Prevention of Diabetes with the Use of a Peer Support Model Habituation App.
Scientific Title
A Feasibility Study of the Effects of Lifestyle Modification on Prevention of Diabetes with the Use of a Peer Support Model Habituation App.
Scientific Title:Acronym
A Feasibility Study of the Effects of Lifestyle Modification on Prevention of Diabetes with the Use of a Peer Support Model Habituation App.
Region
| Japan |
Condition
Condition
Type 2 diabetes and pre-diabetes
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct a feasibility study on lifestyle-improving effects on diabetes using a smartphone peer-supported habit-forming app
Basic objectives2
Others
Basic objectives -Others
At the start of the study, the study subjects set a target value for the daily number of steps for each individual, and aim to achieve it continuously. The group is divided into two groups: a group that uses the habit-forming app and a group that does not use the habit-forming app. The non-use group has no team and works on their own to achieve the goal. Promote human behavior change through peer support, peer pressure, self-cognition (cognitive behavioral therapy), and achievements (coins, batch acquisition) for the habit-forming app for use groups.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The achievement rate of the steps-a-day goal planned at first.
Key secondary outcomes
Weight, BMI, blood pressure, HbA1c
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using the Habituation App, you can know the number of steps you take every day and challenge each person to achieve their goals in groups of five. Once a day about the results, post the number of steps + photos to your team and share information with each other.
Interventions/Control_2
Use the Steps app to know your daily steps, but don't have a team, work on your own goals. No posting or sharing of information will be done.
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
| 71 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Type 2 diabetes and pre-diabetes: HbA1c 5.6% or more and less than 7.0%
2 Males and females aged between 40 and 74
3 Person having smartphone
4 Person who receive adequate explanation for participation in this research and provide written informed consent by their own free will
Key exclusion criteria
1 Person who has a disorder that is an obstacle to this study
2 Have severe diabetes symptoms or disability
3 Others who are deemed inappropriate by the research leader or co-worker
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Nagasaka |
Organization
A10 Lab Inc.
Division name
Founder, CEO
Zip code
150-0013
Address
3F, Touyou Bldg. 1-8-5, Ebisu, Shibuya-ku, Tokyo
TEL
03-5422-8396
go.nagasaka@a10lab.com
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Shibuya |
Organization
A10 Lab Inc.
Division name
Business development
Zip code
150-0013
Address
3F, Touyou Bldg. 1-8-5, Ebisu, Shibuya-ku, Tokyo
TEL
03-5422-8396
Homepage URL
megumi.shibuya@a10lab.com
Sponsor or person
Institute
A10 Lab Inc.
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
A10 Lab Inc.
Address
3F, Touyou Bldg. 1-8-5, Ebisu, Shibuya-ku, Tokyo
Tel
03-5422-8396
contact@a10lab.com
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
| 2020 | Year | 02 | Month | 14 | 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
58
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
| 2019 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 12 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044999
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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