UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030927 |
|---|---|
| Receipt number | R000035320 |
| Scientific Title | Life style disease and BEhavior modification STage: LIFE style intervention using the IoT devices |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2023/07/28 10:44:28 |
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Basic information
Public title
Life style disease and BEhavior modification STage: LIFE style intervention using the IoT devices
Acronym
The BEST-LIFE study 2
Scientific Title
Life style disease and BEhavior modification STage: LIFE style intervention using the IoT devices
Scientific Title:Acronym
The BEST-LIFE study 2
Region
| Japan |
Condition
Condition
diabetes mellitus and metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify if remote lifestyle guidance using activity scale, health meter and blood pressure meter is effective to improve diabetic control by changing behavior modification stage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in HbA1c from baseline to three months and one year.
Key secondary outcomes
1,The change in abdominal circumference, blood pressure, lipids and fasting glucose
2, Behavior modification stage and literacy of lifestyle
3, The association between daily records and HbA1c, abdominal circumference, blood pressure, lipids and fasting glucose
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Monitoring of daily data using activity meter, health meter and blood pressure meter, remote health guidance by public health nurse and automatically delivery advices for one year
Interventions/Control_2
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
1,Member of "kenko ikiiki Nabi" club
2,HbA1c >=6.5% or
a)abdominal circumference: over 85cm in men, over 90 cm in women
b)blood pressure: over 130 mmHg in systolic, over 85mmHg in diastolic
c)fasting glucose: over 110mg/dL
d)Lipid: over 150mg/dL in TG or under 40 mg/dL in HDL
3, Informed Consent
Key exclusion criteria
1, Subject who is prohibited exercise therapy by his/her doctor
2, Subject who is considered inappropriate to participate this trial
Target sample size
250
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
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
+81-52-744-2192
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
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
+81-52-744-2192
Homepage URL
kato07@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Toyota Motor Corporation
Mealcare Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya
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
| 2018 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035320
| 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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| Registered date | File name |
