UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of personalized nutrition education during pregnancy on maternal nutritional status and infant birth weight: Randomized control trial study.
Title of the study (Brief title)	Impact of personalized nutrition education on maternal and infant nutritional status
Region	Japan

Condition
Condition	Low Birth weight of infant
Classification by specialty	Obsterics and gynecology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The prevention of Low Birth weight
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maternal weight gain during pregnancy Birth weight of infant
Key secondary outcomes	Food and nutrient intakes Serum 25(OH)D

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	General group nutrition education( 1 time)and personalized nutrition education (Twise)
Interventions/Control_2	General group nutrition education( 1 time)
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	45 years-old >
Gender	Female
Key inclusion criteria	before 22 week,single pregnancy,
Key exclusion criteria	after 22 week, twin pregnancy PIH GDM
Target sample size	130

Research contact person
Name of lead principal investigator	Yukari Takemi
Organization	Graduate school of Kagawa Nutrition University
Division name	Nutrition ecology
Address	3-9-21 Chiyoda,Sakado,Saitama
TEL	049-8722-3721
Email	Takemi@eiyo.ac.jp

Public contact
Name of contact person	Kaoru Uno
Organization	Graduate school of Kagawa Nutrition University
Division name	Nutrition ecology
Address	3-9-21 Chiyoda,Sakado,Saitama
TEL	049-8722-3721
Homepage URL
Email	uka141@eiyo.ac.jp

Sponsor
Institute	Graduate school of Kagawa Nutrition University
Institute
Department

Funding Source
Organization	Graduate school of Kagawa Nutrition University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Luvtelli Tokyo & New york,Sato Hospital
Name of secondary funｄer(s)

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	産科婦人科舘出張佐藤病院（群馬県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 11 Day
Anticipated trial start date	2015 Year 01 Month 05 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 04 Day
Last modified on	2017 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018710