UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039396 |
|---|---|
| Receipt number | R000044918 |
| Scientific Title | A Feasibility Study on the Effects of Lifestyle Modification Regarding Diabetes with the Use of a Peer Support Model Habituation App. |
| Date of disclosure of the study information | 2020/02/05 |
| Last modified on | 2020/09/28 15:33:57 |
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Basic information
Public title
A Feasibility Study on the Effects of Lifestyle Modification Regarding Diabetes with the Use of a Peer Support Model Habituation App.
Acronym
A Feasibility Study on the Effects of Lifestyle Modification Regarding Diabetes with the Use of a Peer Support Model Habituation App.
Scientific Title
A Feasibility Study on the Effects of Lifestyle Modification Regarding Diabetes with the Use of a Peer Support Model Habituation App.
Scientific Title:Acronym
A Feasibility Study on the Effects of Lifestyle Modification Regarding 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
HbA1c
Key secondary outcomes
Weight, BMI, blood pressure, achievement rate
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
| 74 | 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 holding 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 | Yasuhiro |
| Middle name | |
| Last name | Nishizaki |
Organization
Tokai University School of Medicine
Division name
Department of Clinical Health Science
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463-93-1121
y-nishizaki@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Takashige |
| Middle name | |
| Last name | Oroguchi |
Organization
Tokai University School of Medicine
Division name
Lifecare Center Graduate School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
TEL
0463-93-1121
Homepage URL
oroguchi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
A10 Lab Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University Hospital
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
東海大学医学部大学院医学研究科ライフケアセンター(神奈川)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 05 | 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
| 2019 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 04 | 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
| 2020 | Year | 02 | Month | 05 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044918
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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