UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049336 |
|---|---|
| Receipt number | R000056189 |
| Scientific Title | Survey about women's physical and mental health and lifestyle habit |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2022/10/27 09:07:18 |
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Basic information
Public title
Survey about women's physical and mental health and lifestyle habit
Acronym
Survey about women's physical and mental health and lifestyle habit
Scientific Title
Survey about women's physical and mental health and lifestyle habit
Scientific Title:Acronym
Survey about women's physical and mental health and lifestyle habit
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reveal the relationship between young women's physical and mental health conditions and lifestyle habit, and deepen understanding of mental and physical health and lifestyle habits of women of various generations by analyzing multiple studies integrally
Basic objectives2
Others
Basic objectives -Others
Reveal the relationship between young women's physical and mental health conditions and lifestyle habit, and deepen understanding of mental and physical health and lifestyle habits of women of various generations by analyzing multiple studies integrally
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Menstrual troubles and physical and mental conditions based on them
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Women between the ages of 18 and under 35
(2) Those who understand the content of Fitbit's privacy policy(https://www.fitbit.com/global/jp/legal/privacy-Policy), and those who agree to acquire various personal information such as the number of steps, distance traveled, calories burned, weight, heart rate, and sleep stages by Fitbit when you wear an activity meter that measures your sleep state
(3) Those who agreed to the secondary use of the data for this research
Key exclusion criteria
(1) Those who suffer from serious diseases (heart disease, kidney disease, liver disease, congenital heart disease, cancer, etc.) and those who have a history of them
(2) Those who suffer from gynecological diseases such as uterine fibroids, endometriosis, cervical cancer, endometrial cancer, ovarian cancer (excluding dysmenorrhea and premenstrual syndrome), and those who have a history of them
(3) Those who underwent medication or surgery due to serious illness or injury within 2 months of the date of the visit measurement, and those who were judged inappropriate by the research director or the person (in charge of the research excluding sexual symptoms)
(4) Those who have given birth
(5) Those who are pregnant or breastfeeding
(6) Those who are reluctant to sleep with an activity meter (Fitbit) that measures their sleep status
(7) Those who are unable to maintain certain (same) habits during the home measurement period, such as taking foods for specified health uses, foods with function claims, and dietary supplements
(8) Those with metal allergies, those with a pacemaker
(9) Those who have been infected with the COVID-19, have not recovered by the start date of the survey, and are not permitted to return to work in accordance with the internal regulations "Manual to COVID-19". Those who have a fever, respiratory symptoms, and are suspected of being infected with the COVID-19. Those who have become close contacts and are not allowed to come to work. Others who, in accordance with internal regulations, have been judged by the research supervisor or research staff to be difficult to participate in the study due to events related to COVID-19.
(10) In addition, those who are judged by the person in charge of testing and research to be unsuitable for the test.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Haruko |
| Middle name | |
| Last name | Toyoshima |
Organization
Kao Corporation
Division name
R&D Strategy
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-80-8466-6055
toyoshima.haruko@kao.com
Public contact
Name of contact person
| 1st name | Mizuki |
| Middle name | |
| Last name | Tsunakawa |
Organization
Kao Corporation
Division name
Health & Wellness Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3296-8341
Homepage URL
tsunakawa.mizuki@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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
| 2022 | Year | 11 | Month | 01 | 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
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association analysis between physical conditions, menstrual conditions, lifestyle and mental conditions
Management information
Registered date
| 2022 | Year | 10 | Month | 27 | Day |
Last modified on
| 2022 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056189
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
