UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029143
Receipt number R000033317
Scientific Title Investigation of Effect of FiNC-style Specific Health Guidance
Date of disclosure of the study information 2017/09/14
Last modified on 2020/09/23 15:36:27

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Basic information

Public title

Investigation of Effect of FiNC-style Specific Health Guidance

Acronym

Investigation of Effect of FiNC-style Specific Health Guidance

Scientific Title

Investigation of Effect of FiNC-style Specific Health Guidance

Scientific Title:Acronym

Investigation of Effect of FiNC-style Specific Health Guidance

Region

Japan


Condition

Condition

People who meet criteria of and Specific Health Guidance based on Specific Health Checkups

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate FiNC-style specific health guidance effect on weight loss as well as risk reduction of lifestyle diseases

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of body weight after 3-month intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

FiNC-style Specific health guidance

Interventions/Control_2

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

1. People who are eligible for active support in specific health guidance
2. People who are able to use FiNC application

Key exclusion criteria

1. People who are participating another intervention study
2. People who are prohibited to lose weight by diet improvement in the judgment of medical doctors

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shin
Middle name
Last name Murakami

Organization

FiNC, Inc.

Division name

Life Science Department

Zip code

100-0006

Address

Shin-Yurakucho Bldg. 5F, 1-12-1 Yurakucho, Chiyoda-ku, Tokyo, Japan.

TEL

03-6206-3480

Email

shin.murakami@finc.com


Public contact

Name of contact person

1st name Shin
Middle name
Last name Murakami

Organization

FiNC, Inc.

Division name

Life Science Department

Zip code

1000006

Address

Shin-Yurakucho Bldg. 5F, 1-12-1 Yurakucho, Chiyoda-ku, Tokyo, Japan.

TEL

03-6206-3480

Homepage URL


Email

shin.murakami@finc.com


Sponsor or person

Institute

FiNC, Inc.

Institute

Department

Personal name



Funding Source

Organization

FiNC, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiba Place Clinic Ethics Review Committee

Address

1-9-10 Hamamatsucho Minato-ku Tokyo

Tel

03-5408-1590

Email

jimukyoku@mail.souken-r.com


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 09 Month 14 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

10

Results

In both groups, the number of people who lost or increased their weight and abdominal circumference after 6 months exceeded the number of people who increased.
It was suggested that the guidance content common to both groups is the effect of legal specific health guidance and exercise guidance through apps.

Results date posted

2020 Year 09 Month 23 Day

Results Delayed

Delay expected

Results Delay Reason

Delayed publication of results from A municipality

Date of the first journal publication of results


Baseline Characteristics

Among the members of the A health insurance association, etc., those who correspond to active support in the judgment of the person subject to specific health guidance

Participant flow

Allocate to 2 groups
Intervention group: In addition to legal specific health guidance, receive dietary guidance for 2 months using the chat room on the smartphone app
Control group: Legal specific health guidance only

Adverse events

nothing

Outcome measures

body weight
Abdominal circumference

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 07 Month 06 Day

Date of IRB

2017 Year 07 Month 13 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2018 Year 03 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

2017 Year 09 Month 14 Day

Last modified on

2020 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033317


Research Plan
Registered date File name
2020/09/23 研究計画書UMIN.pdf

Research case data specifications
Registered date File name
2020/09/23 UMIN_data_spec.xlsx

Research case data
Registered date File name
2020/09/23 UMIN_data.xlsx