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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023356
Receipt No. R000026576
Scientific Title Lifestyle intervention using IoT (internet of things) devices in senior citizens
Date of disclosure of the study information 2016/09/01
Last modified on 2017/09/13

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Basic information
Public title Lifestyle intervention using IoT (internet of things) devices in senior citizens
Acronym Lifestyle intervention using IoT (the BEST LIFE study)
Scientific Title Lifestyle intervention using IoT (internet of things) devices in senior citizens
Scientific Title:Acronym Lifestyle intervention using IoT (the BEST LIFE study)
Region
Japan

Condition
Condition Lifestyle disease
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify if lifestyle guidance using activity scale, health meter and blood pressure meter is effective to change into healthy life style and control diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of HbA1c after the 6-month intervention
Key secondary outcomes Stage of health behavior, Blood pressure, Body weight

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Monitoring of daily data using activity meter, health meter and blood pressure meter and health guidance by public health nurse
Interventions/Control_2 Self management
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Member of Toyota Health Navigator Club
HbA1c >= 5.6 %
Informed consent
Key exclusion criteria Subject who is prohibited exercise therapy by his/her doctor
Subject who is considered inappropriate to participate this research
Target sample size 140

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shoichi Maruyama
Organization Nagoya University Graduate School of Medicine
Division name Nephrology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya, Aichi
TEL 052-744-2192
Email marus@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Sawako Kato
Organization Nagoya University Graduate School of Medicine
Division name Nephrology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya, Aichi
TEL 052-744-2192
Homepage URL
Email kato07@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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 TOYOTA MOTOR CORPORATION
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 09 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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2017 Year 11 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 27 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026576

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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