UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047129 |
|---|---|
| Receipt number | R000053760 |
| Scientific Title | An exploratory study of the impact of dietary recording and nutritional guidance on pregnancy outcomes with mobile application. |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2024/09/09 09:18:37 |
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Basic information
Public title
An exploratory study of the impact of dietary recording and nutritional guidance on pregnancy outcomes with mobile application.
Acronym
Impact of dietary recording on pregnancy outcomes with mobile application.
Scientific Title
An exploratory study of the impact of dietary recording and nutritional guidance on pregnancy outcomes with mobile application.
Scientific Title:Acronym
Impact of dietary recording on pregnancy outcomes with mobile application.
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comprehensively explore the association between pregnant women's diet and nutritional intake and their weight gain during pregnancy, pregnancy and delivery outcomes and neonatal outcomes, using a mobile application for pregnant women to record their diet.
Basic objectives2
Others
Basic objectives -Others
To examine the potential of app-based dietary management during pregnancy to promote behaviour change in pregnant women.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight gain during pregnancy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use of healthcare apps during pregnancy.
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnant women who are managed at Kyoto University Hospital.
Pregnant women who can use smart phone and mobile application.
Key exclusion criteria
Women who need to receive dietary and nutritional guidance from a dietician due to co-morbidities.
Women who cannot use mobile application.
Women deemed by the principal investigator to be inappropriate for inclusion in the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Yamaguchi |
Organization
Garduate School of Medicine, Kyoto University
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto.
TEL
075-751-3269
soulken@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitsugu |
| Middle name | |
| Last name | Chigusa |
Organization
Garduate School of Medicine, Kyoto University
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto.
TEL
075-751-3269
Homepage URL
chigusa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Garduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida konoe-cho, Sakyo-ku, Kyoto.
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2022 | Year | 05 | 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 | 03 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Currently, the number of research subjects is small, and the actual number of subjects who have given consent for research is also small.
Management information
Registered date
| 2022 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053760
