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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030075
Receipt No. 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 2017/11/20

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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
Middle name
Last name Hiroaki Masuzaki
Organization Graduate School of Medicine, University of the Ryukyus.
Division name Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
Address 207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL 098-895-1146
Email hiroaki@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsugumi Uema
Organization Graduate School of Medicine, University of the Ryukyus.
Division name Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
Address 207 Uehara, Nishihara, Okinawa,903-0215,Japan
TEL 098-895-1146
Homepage URL
Email ma2.ky8.26@gmail.com

Sponsor
Institute University of the Ryukyus.
Institute
Department

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
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
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 Preinitiation
Date of protocol fixation
2017 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033902

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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