UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053687 |
|---|---|
| Receipt number | R000059648 |
| Scientific Title | Investigation of daily lifestyle-related pregnant body weight change: prospective cohort study |
| Date of disclosure of the study information | 2024/02/22 |
| Last modified on | 2024/02/22 18:04:14 |
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Basic information
Public title
Investigation of daily lifestyle-related pregnant body weight change: prospective cohort study
Acronym
Investigation of daily lifestyle-related pregnant body weight change: prospective cohort study
Scientific Title
Investigation of daily lifestyle-related pregnant body weight change: prospective cohort study
Scientific Title:Acronym
Investigation of daily lifestyle-related pregnant body weight change: prospective cohort study
Region
| Japan |
Condition
Condition
Pregnant
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An observational study (prospective cohort study) will be conducted in which dietary surveys using a food management application and a web-based questionnaire survey will be conducted regularly during the regular checkups of pregnant women. The main outcome will be weight change in pregnant women, and the timing and content of daily activities such as eating, sleeping, and exercise during pregnancy will be analyzed from the perspective of chronobiology and chrononutrition in order to gain new knowledge in an exploratory manner.
Basic objectives2
Others
Basic objectives -Others
Explore items related to food timing
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight change during pregnancy
Key secondary outcomes
Results of regular health checkups for pregnant women (blood pressure, urinalysis, abdominal circumference, blood test, blood glucose level)
Results of web-based surveys (sleep defects, stress indicators, subjective sense of health, happiness, anxiety, and depression)
Birth weight, results of one-month checkup (weight, urinalysis, depression level)
Daily changes in blood glucose levels, diurnal rhythm
Intestinal microflora analysis
Physical activity, sleep rhythm, heart rate
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Pregnant women who can provide written consent to participate in the study of their own free will
2) Pregnant women 18 years of age or older who have undergone a prenatal checkup at our hospital and are scheduled to deliver, to search for items related to diet timing.
Key exclusion criteria
1) Those who are unable to use smartphones
2) Those whose doctor has determined that it would be difficult for them to continue to cooperate in the study (e.g., those on insulin therapy).
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hisaya |
| Middle name | |
| Last name | Fujiwara |
Organization
Chugoku Rosai Hospital
Division name
department of obstetrics and gynaecology
Zip code
737-0193
Address
Kure-shi, Tagaya 1-5-1, Hiroshima
TEL
0823-72-7171
hisafuji@chugokuh.johas.go.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Kamigaki |
Organization
Chugoku Rosai Hospital
Division name
department of obstetrics and gynaecology
Zip code
737-0193
Address
Kure-shi, Tagaya 1-5-1, Hiroshima
TEL
0823-72-7171
Homepage URL
nishi2012bus@gmail.com
Sponsor or person
Institute
Chugoku Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Organization of Occupational Health and Safety
Address
Kanagawa, Kawasaki, Nakahara, Sumiyoshi, 1-1
Tel
044-431-8641
kenkyu@honbu.johas.go.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
中国労災病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 22 | 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
| 2023 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2024 | Year | 02 | Month | 22 | 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=R000059648
| Research Plan | |
|---|---|
| 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 |
