UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034751
Receipt number R000039608
Scientific Title 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 2024/02/19 16:27:00

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Basic information

Public title

Efficacy of a fully-automated, diet-centered coaching application on behavior modification for Japanese adults with obesity

Acronym

Kanazawa-SLIM study

Scientific Title

Efficacy of a fully-automated, diet-centered coaching application on behavior modification for Japanese adults with obesity

Scientific Title:Acronym

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

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

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

conventional specific health guidance

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

1st name Takashi
Middle name
Last name Yoneda

Organization

Kanazawa University Hospital

Division name

Internal medicine of Endocrinology and Metabolism

Zip code

920-8641

Address

Ishikawa Kanazawa-city takaramachi 13-1

TEL

076-265-2252

Email

endocrin@med.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name Mitsuhiro
Middle name
Last name Kometani

Organization

Kanazawa University Hospital

Division name

Internal medicine of Endocrinology and Metabolism

Zip code

920-8641

Address

Ishikawa Kanazawa-city takaramachi 13-1

TEL

076-265-2252

Homepage URL


Email

mkome@med.kanazawa-u.ac.jp


Sponsor or person

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name



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.
Houju Memorial Hospital
Hokuriku Central Hospital
Yawata Medical Center
Kanazawa Medical Association
Ishikawa Health Service Association

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kanazawa University, Medical department, Ethics Committee

Address

Ishikawa Kanazawa-city takaramachi 13-1

Tel

076-265-2100

Email

t-isomu@adm.kanazawa-u.ac.jp


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


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

Open public recruiting

Date of protocol fixation

2018 Year 10 Month 17 Day

Date of IRB

2018 Year 10 Month 17 Day

Anticipated trial start date

2018 Year 11 Month 02 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2024 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 11 Month 02 Day

Last modified on

2024 Year 02 Month 19 Day



Link to view the page

Value
https://center6.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