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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/33317
