UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051573 |
|---|---|
| Receipt number | R000058842 |
| Scientific Title | Lifestyle Survey of Postpartum Mothers and Infants |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/02/22 17:49:55 |
* 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
Lifestyle Survey of Postpartum Mothers and Infants
Acronym
Lifestyle Survey of Postpartum Mothers and Infants
Scientific Title
Lifestyle Survey of Postpartum Mothers and Infants
Scientific Title:Acronym
Lifestyle Survey of Postpartum Mothers and Infants
Region
| Japan |
Condition
Condition
Postpartum mothers
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, through an online research company, we will conduct a questionnaire survey of mothers with firstborn children aged 0-12 months to determine the lifestyle habits and social backgrounds of the mothers and children (e.g., parents' work status and annual income). Through these surveys, we will search for items that are associated with maternal sleep problems in an exploratory manner, with the aim of obtaining useful information for future intervention studies. In particular, we will explore the daily behaviors and social backgrounds that are associated with the presence or absence of sleep problems in mothers. We will also explore the mothers' daily behaviors and social backgrounds that are associated with the time it takes to establish a sleep rhythm after birth.
Basic objectives2
Others
Basic objectives -Others
Cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between eating habits and maternal sleep
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Mothers with first child 0-12 months of age
Key exclusion criteria
NONE
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | YU |
| Middle name | |
| Last name | TAHARA |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
7340037
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
TEL
07026426103
yutahara@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | YU |
| Middle name | |
| Last name | TAHARA |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
7340037
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
TEL
07026426103
Homepage URL
yutahara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Combi 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
Hiroshima University
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
Tel
082-257-5907
iryo-seisaku@office.hiroshima-u.ac.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
| 2024 | Year | 04 | 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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
NA.
Management information
Registered date
| 2023 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058842
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
