UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023356 |
|---|---|
| Receipt number | 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 | 2023/03/03 11:46:20 |
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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
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Maruyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Nephrology
Zip code
4540056
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2192
marus@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Sawako |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Graduate School of Medicine
Division name
Nephrology
Zip code
4640056
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2192
Homepage URL
kato07@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
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
TOYOTA MOTOR CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Aichi
Tel
052-744-2973
ethics@med.nagoya-u.ac.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
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
| 2016 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 27 | 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
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026576
