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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019035
Receipt No. R000021983
Scientific Title A study on diabetes prevention effect of "the Tacho machi system"
Date of disclosure of the study information 2016/04/01
Last modified on 2016/03/03

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Basic information
Public title A study on diabetes prevention effect of "the Tacho machi system"
Acronym A study on diabetes prevention effect of "the Tacho machi system"
Scientific Title A study on diabetes prevention effect of "the Tacho machi system"
Scientific Title:Acronym A study on diabetes prevention effect of "the Tacho machi system"
Region
Japan

Condition
Condition Pre-diabetes
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to review that "Taco-machi system" is effective in reducing HbA1c.
"Tacho-machi system" is recording of daily amount of activity, body weight, ingested meal and automatically generated advice on exercise, nutrition and taking alcohol these are based on recordings to smart phone, PC with subjects to prevent diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decreasing of HbA1c are accessed after 3 months of using the system.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Factor 1 (daily body weight recording, daily activity monitor recording, daily meal recording): (+)
Factor 2 (Advice by diabetes prevention application "Tacho-machi system"): (+)
Term of interventions: 3 months
Interventions/Control_2 Factor 1 (daily body weight recording, daily activity monitor recording, daily meal recording): (+)
Factor 2 (Advice by diabetes prevention application "Tacho-machi system"): (-)
Term of interventions: 3 months
Interventions/Control_3 Control group
Factor 1 (daily body weight recording, daily activity monitor recording, daily meal recording): (-)
Factor 2 (Advice by diabetes prevention application "Tacho-machi system"): (-)
Term of interventions: 3 months
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 5.6=<HbA1c=<6.2 (before trial)
Key exclusion criteria At start of trial, treatment in diabetes or other lifestyle-related diseases.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Hosokawa
Organization Prefectural University of Hiroshima
Division name Faculty of Health and Welfare
Zip code
Address Gakuen-machi1-1, Mihara-shi, Hiroshima, Japan
TEL 0848-60-1276
Email hosokawa@pu-hiroshima.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Hosokawa
Organization Prefectural University of Hiroshima
Division name Faculty of Health and Welfare
Zip code
Address Gakuen-machi1-1, Mihara-shi, Hiroshima, Japan
TEL 0848-60-1276
Homepage URL
Email hosokawa@pu-hiroshima.ac.jp

Sponsor
Institute NTT Data Institute if Management Consulting, Inc.
Institute
Department

Funding Source
Organization Ministry if internal affairs and communications of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 04 Month 01 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 Completed
Date of protocol fixation
2015 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 20 Day
Last follow-up date
2016 Year 02 Month 29 Day
Date of closure to data entry
2016 Year 03 Month 01 Day
Date trial data considered complete
2016 Year 03 Month 03 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 16 Day
Last modified on
2016 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021983

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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