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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039396
Receipt No. 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 2020/02/05

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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
Email 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
Email oroguchi@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

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
Email 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
2020 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
2020 Year 02 Month 05 Day
Last modified on
2020 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044918

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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