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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034751
Receipt No. R000039608
Official scientific title of the study Efficacy of a fully-automated, diet-centered coaching application on behavior modification for Japanese adults with obesity
Date of disclosure of the study information 2018/11/03
Last modified on 2018/11/02

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Basic information
Official scientific title of the study Efficacy of a fully-automated, diet-centered coaching application on behavior modification for Japanese adults with obesity
Title of the study (Brief title) Kanazawa-SLIM study
Region
Japan

Condition
Condition obesity
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the improvement of lipid profile and behavior modification after 6 months intervention using IoT device for Japanese adults receiving the specific health guidance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes lipid profile
(Total cholesterol, TG, HDL-cholesterol, LDL-cholesterol)
Key secondary outcomes i)The proportion of behavior modification from preparation stage to action stage according to the questionnaire.
ii)The rate of response to public health nurse after 6 months.
iii)The achievement rate of the behavior goal planned at first.
iv)The information recorded on application.
(The number of recording time and meal, calorie intake, calorie consumption, nutrient composition, step counts, etc)
v)metabolic parameters(body weight, blood pressure, HbA1c, fatty acid fraction, lipoprotein fraction)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 Adding the online guidance using AI and IoT on conventional specific health guidance.

i)Record meals on the application and get feed back from AI nutritionist.
ii)Record body weights using weight scale connected with the application.
iii)Record the blood pressure using sphygmomanometer connect with the application.
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
40 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria i)Those who receiving specific health guidance
ii)Written informed consent
iii)Ability of using smartphone
iv)Ability of continual food records
Key exclusion criteria i)Not applicable to take specific health guidance
ii)Taking medications for hypertension, dyslipidemia and/or diabetes mellitus
iii)Individuals ineligible for the study determined by doctors
Target sample size 600

Research contact person
Name of lead principal investigator Takashi Yoneda
Organization Kanazawa University Hospital
Division name Internal medicine of Endocrinology and Metabolism
Address Ishikawa Kanazawa-city takaramachi 13-1
TEL 076-265-2252
Email endocrin@med.kanazawa-u.ac.jp

Public contact
Name of contact person Mitsuhiro Kometani
Organization Kanazawa University Hospital
Division name Internal medicine of Endocrinology and Metabolism
Address Ishikawa Kanazawa-city takaramachi 13-1
TEL 076-265-2252
Homepage URL
Email mkome@med.kanazawa-u.ac.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor WIT Co.Ltd.
Name of secondary funder(s)

Secondary IDs
Secondary IDs YES
Study ID_1 18le0110007h0001
Org. issuing International ID_1 Japan Agency for Medical Research and Development
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 11 Month 03 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 10 Month 17 Day
Anticipated trial start date
2018 Year 11 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 02 Day
Last modified on
2018 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039608

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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