UMIN-CTR Clinical Trial

Basic information
Public title	Dietary habits of pregnant women and birth weight of their babies
Acronym	Dietary habits of pregnant women and birth weight of their babies
Scientific Title	Dietary habits of pregnant women and birth weight of their babies
Scientific Title:Acronym	Dietary habits of pregnant women and birth weight of their babies
Region	Japan

Condition
Condition	Pregnancy
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the management of weight gain during pregnancy and birth weight using an app.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Birthweight
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Provide nutritional management for pregnant women through diet-related apps.
Interventions/Control_2	No intervention in the diet, using only an app to check the diet.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Pregnant women undergoing prenatal checkups at our hospital.
Key exclusion criteria	Pregnant women whose details of pregnancy and delivery progress are unknown
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Yoshifumi Middle name Last name Kasuga
Organization	Keio University School of Medicine
Division name	Obstetrics and Gynecology
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	kasuga@keio.jp

Public contact
Name of contact person	1st name Yoshifumi Middle name Last name Kasuga
Organization	Keio University School of Medicine
Division name	Obstetrics and Gynecology
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	kasuga@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Self funding.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University School of Medicine
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.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	2021 Year 06 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	Terminated
Date of protocol fixation	2021 Year 02 Month 08 Day
Date of IRB	2021 Year 08 Month 19 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 10 Day
Last modified on	2021 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049409