UMIN-ICDS Clinical Trial

Public title

Survey about Chinese young women's physical and mental health and lifestyle habit

Acronym

Survey about Chinese young women's physical and mental health and lifestyle habit

Scientific Title

Survey about Chinese young women's physical and mental health and lifestyle habit

Scientific Title:Acronym

Survey about Chinese young women's physical and mental health and lifestyle habit

Region

Asia(except Japan)

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Reveal about Chinese young women's physical and mental health conditions and lifestyle habit and their relationship

Basic objectives2

Others

Basic objectives -Others

Reveal about Chinese young women's physical and mental health conditions and lifestyle habit and their relationship

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Menstrual troubles and physical and mental conditions based on them

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

30

years-old

>

Gender

Female

Key inclusion criteria

(1) Women aged between the age of 18 and under 30
(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

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 cannot confirm negative PCR test within 72 hours by "health code" at the entrance of the test site on the day of the visit
(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

60

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

Email

toyoshima.haruko@kao.com

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

Email

tsunakawa.mizuki@kao.com

Institute

Consumer Behavior Research CORP., Ltd.

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-9064

Email

morisaki.naoko@kao.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

12

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2022

Year

11

Month

28

Day

Date of IRB

2022

Year

11

Month

28

Day

Anticipated trial start date

2022

Year

12

Month

06

Day

Last follow-up date

2023

Year

02

Month

27

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Association analysis between physical condition, menstrual condition, lifestyle and mental conditions

Registered date

2022

Year

12

Month

26

Day

Last modified on

2022

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056722