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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041216
Receipt No. R000046964
Scientific Title Development of a personalized education program for pregnant women aiming adequate nutrition during pregnancy.
Date of disclosure of the study information 2020/07/28
Last modified on 2020/07/27

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Basic information
Public title Development of a personalized education program for pregnant women aiming adequate nutrition during pregnancy.
Acronym Development of a personalized education program for pregnant women aiming adequate nutrition during pregnancy.
Scientific Title Development of a personalized education program for pregnant women aiming adequate nutrition during pregnancy.
Scientific Title:Acronym Development of a personalized education program for pregnant women aiming adequate nutrition during pregnancy.
Region
Japan

Condition
Condition Pregnant
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop an individualized educational program for pregnant women aiming adequate nutrition, and to evaluate its effectiveness to their nutritional intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes After intervention protein intake.
Key secondary outcomes Energy, carbohydrates, lipids, folic acid + iron intake,
Gestational weight gain

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group
Conduct a nutrition education program three times during pregnancy.
Interventions/Control_2 Control group
Conduct a questionnaire survey at the same time as the intervention group.
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
40 years-old >
Gender Female
Key inclusion criteria 1.Pregnant women who are single pregnancy and classified as under weight or normal range by prepregnancy BMI .
2.Japanese who can answer Japanese question papers.
Key exclusion criteria 1.Pregnant women classified as over weight by prepregnancy BMI
2.Uterine malformation
3.Maternal complications that affect fetal development (diabetes, heart disease, severe anemia, etc.)
4.Placenta previa*
5.Hypertensive disorders of pregnancy
6.Fetal abnormality (chromosome aberration, malformation, etc.)
Target sample size 132

Research contact person
Name of lead principal investigator
1st name Hisae
Middle name
Last name Fujimoto
Organization Yokohama City University Graduate School
Division name Graduate School of Medicine
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa, Yokohama-City, Kanagawa
TEL 045-370-7627
Email t196707a@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Hisae
Middle name
Last name Fujimoto
Organization Yokohama City University Graduate School
Division name Graduate School of Medicine
Zip code 236-0004
Address 3-9 Fukuura, Kanazawa, Yokohama-City, Kanagawa
TEL 045-370-7627
Homepage URL
Email t196707a@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School
Institute
Department

Funding Source
Organization None
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 Yokohama City University
Address 3-9 Fukuura, Kanazawa, Yokohama-City, Kanagawa
Tel 045-370-7627
Email ynextedu@yokohama-cu.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
2020 Year 07 Month 28 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2022 Year 01 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
2020 Year 07 Month 27 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046964

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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