UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036348 |
|---|---|
| Receipt number | R000041411 |
| Scientific Title | Monitoring study for change of family lifestyle by mail inspection |
| Date of disclosure of the study information | 2019/03/29 |
| Last modified on | 2021/03/29 09:58:11 |
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Basic information
Public title
Monitoring study for change of family lifestyle by mail inspection
Acronym
Monitoring study for change of family lifestyle by mail inspection
Scientific Title
Monitoring study for change of family lifestyle by mail inspection
Scientific Title:Acronym
Monitoring study for change of family lifestyle by mail inspection
Region
| Japan |
Condition
Condition
Healthy Adults and Children
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify how consciousness for lifestyle and behavior change by continuous using the mail inspection kit in families.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire about health consciousness and condition
Key secondary outcomes
Urinary equol
Urinary salinity
Urinary 8-OHdG
Questionnaire for subject background, meal, exercise and sleep.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use the following mail inspection kit from Healthcare Systems Co., Ltd.
Equol test"Soy Check"
Salt reduction test"Sio Check"
Oxidative stress test"Sabi Check"
The sample is urine.
Subjects take urine and submit the samples by mail.
The test results are notified to the subjects in about two weeks after the subjects send the samples.
Conduct mail inspections at the exam start date and after 3 months, 6 months, and 9 months.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Those who can participate as a family of 4 persons consisting of parents and two children aged 12-18 as of April 1, 2019.
2.The four persons who satisfy 1. are family living together.
3.The same person can continue inspection. (It is impossible for two children to switch to another brother on the way.)
Key exclusion criteria
1.Those who have a chronic disease and are undergoing medication, those with a serious disease history
2.Those who regularly use drugs or quasi-drugs that may affect the intestinal environment, such as antibiotics.
3.Those who are breast-feeding, pregnant, and are planning or hoping pregnancy during the exam.
4.Those who are judged ineligible at the discretion of the research leader.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Minako |
| Middle name | |
| Last name | Takajitsuko |
Organization
Healthcare Systems Co., Ltd
Division name
Marketing and Sales Promotion Division
Zip code
1050004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
takajitsuko@hc-sys.jp
Public contact
Name of contact person
| 1st name | Minako |
| Middle name | |
| Last name | Takajitsuko |
Organization
Healthcare Systems Co., Ltd
Division name
Marketing and Sales Promotion Division
Zip code
1050004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
takajitsuko@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Healthcare Systems Ethics Committee
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
kakehashi@hc-sys.jp
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
| 2019 | Year | 03 | Month | 29 | 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
36
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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 03 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041411
