UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016107 |
|---|---|
| Receipt number | R000018710 |
| Scientific Title | Impact of personalized nutrition education during pregnancy on maternal nutritional status and infant birth weight: Randomized control trial study. |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2017/07/12 15:39:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Impact of personalized nutrition education during pregnancy on maternal nutritional status and infant birth weight: Randomized control trial study.
Acronym
Impact of personalized nutrition education on maternal and infant nutritional status
Scientific Title
Impact of personalized nutrition education during pregnancy on maternal nutritional status and infant birth weight: Randomized control trial study.
Scientific Title:Acronym
Impact of personalized nutrition education on maternal and infant nutritional status
Region
| Japan |
Condition
Condition
Low Birth weight of infant
Classification by specialty
| Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Yukari Takemi |
Organization
Graduate school of Kagawa Nutrition University
Division name
Nutrition ecology
Zip code
Address
3-9-21 Chiyoda,Sakado,Saitama
TEL
049-8722-3721
Takemi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Uno |
Organization
Graduate school of Kagawa Nutrition University
Division name
Nutrition ecology
Zip code
Address
3-9-21 Chiyoda,Sakado,Saitama
TEL
049-8722-3721
Homepage URL
uka141@eiyo.ac.jp
Sponsor or person
Institute
Graduate school of Kagawa Nutrition University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 11 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018710
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
