UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049023 |
|---|---|
| Receipt number | R000055857 |
| Scientific Title | Chrono-nutritional survey in pregnants using a food-log app |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/02/22 17:55:49 |
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Basic information
Public title
Chrono-nutritional survey in pregnants using a food-log app
Acronym
Chrono-nutritional survey in pregnants using a food-log app
Scientific Title
Chrono-nutritional survey in pregnants using a food-log app
Scientific Title:Acronym
Chrono-nutritional survey in pregnants using a food-log app
Region
| Japan |
Condition
Condition
pregnant mothers
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
According to the Ministry of Health, Labor and Welfare's "Dietary Guidelines for Pregnant Women Starting Before Pregnancy," Japanese women tend to have a low BMI, making it difficult for them to gain weight well during pregnancy. In the West, on the other hand, overweight during pregnancy is often a problem. Overseas research institutes have reported that the causes of excessive weight gain are related to body clocks and life rhythms, such as a nocturnal lifestyle, jet lag on weekends, and frequent dinners and evening meals. On the other hand, there are no reports on chronobiology with regard to Japanese pregnant women. Therefore, this study will investigate the relationship between lifestyle and eating habits and weight change, sleep, and health during pregnancy in Japanese pregnant women. The survey will be widely conducted among users registered in the pregnant women's course of the dietary management application ASUKEN, with the aim of obtaining long-term data.
Basic objectives2
Others
Basic objectives -Others
No information
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight change during the pregnancy
Key secondary outcomes
Dietary changes, sleep changes, birth fetal weight
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Users of the diet management app Asken's Pregnancy Course
Key exclusion criteria
Basically, this study does not set any exclusion criteria. The reason for not establishing exclusion criteria is that we are not asking the participants to provide personal information such as their medical history, so it is difficult to establish exclusion criteria.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Shigenobu |
| Middle name | |
| Last name | Shibata |
Organization
Waseda University
Division name
School of Advanced Science and Engineering
Zip code
1620056
Address
Wakamatsu-cho 2-2, Shinjuku-ku, Tokyo
TEL
03-5369-7318
shibatas@waseda.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Waseda University
Division name
School of Advanced Science and Engineering
Zip code
1620056
Address
Wakamatsu-cho 2-2, Shinjuku-ku, Tokyo
TEL
03-5369-7318
Homepage URL
yutahara0829@gmail.com
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
Totsuka 1-104, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2023 | Year | 12 | 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 | 25 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Data collecting has been done, and now analyzing the data.
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055857
