UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030075 |
|---|---|
| Receipt number | R000033902 |
| Scientific Title | Interventional study on behavioral changes,prevention and modification of lifestyle-related metabolic diseases by use of digital health devices in Kumejima island |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2023/09/17 12:34:30 |
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Basic information
Public title
Interventional study on behavioral changes,prevention and modification of lifestyle-related metabolic diseases by use of digital health devices in Kumejima island
Acronym
Digital health devices-based interventional study in Kumajima island
Scientific Title
Interventional study on behavioral changes,prevention and modification of lifestyle-related metabolic diseases by use of digital health devices in Kumejima island
Scientific Title:Acronym
Digital health devices-based interventional study in Kumajima island
Region
| Japan |
Condition
Condition
Obesity,Metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Utilizing the highly integrated medical information infrastructure (LHR: Lifetime Health Record) system as well as digital health devices, we plan to collect individual medical and ecological information. Data include survey questionnaires, activity levels, behavioral characteristics and blood data all of which
are subjected to explore factors that contribute either to the prevention or progression of lifestyle-related diseases data by artificial intelligence, we try to develop algorithms for estimating optimal lifestyle habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the improvement of lifestyle, quality of life (by analyzing questionnaires) and clinical indices by use of digital health devices.
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
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearable activity records and application for health promotion in smartphones are always used for 6 months.
Interventions/Control_2
Wearable activity records and application for health promotion in smartphones are not used for 6 months.
Interventions/Control_3
Wearable activity records and application for health promotion in smartphones are always used for 18 months.
Interventions/Control_4
Wearable activity records and application for health promotion in smartphones are not used for 18 months.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who were diagnosed as having obesity, metabolic syndrome, borderline diabetes, insulin resistance.
Key exclusion criteria
1.Severe renal function disorder.
2.Severe liver function disorder.
3.History of malignant tumor.(Possible entry:no recrudescence of tumor more than 2 years.)
4.Pregnant women or women suspected of being pregnant.
5.Who have a chronic diarrhea.
6.An adult judged objectively if it lacks the ability to give informed consent.
7.Currently and as soon as having a disease requiring hospitalization.
8.Inappropriate as an object of this examination by other reason.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Masuzaki |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL
098-895-1146
hiroaki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Tsugumi |
| Middle name | |
| Last name | Uema |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL
098-895-1146
Homepage URL
ma2.ky8.26@gmail.com
Sponsor or person
Institute
University of the Ryukyus.
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office, Government of Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Support center
Address
207 Uehara, Nishihara, Okinawa,903-0215,Japan
Tel
098-895-1351
noboteru@jim.u-ryukyu.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
| 2017 | Year | 12 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033902
