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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029204
Receipt No. R000033384
Scientific Title A Study on Nutrition Education Materials and Socio-Economic Factors in Pregnant Women: A feasibility study of Food Acquisition Management Guide
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/20

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Basic information
Public title A Study on Nutrition Education Materials and Socio-Economic Factors in Pregnant Women: A feasibility study of Food Acquisition Management Guide
Acronym A feasibility study of food maquisition management guide for pregnant women as education materials
Scientific Title A Study on Nutrition Education Materials and Socio-Economic Factors in Pregnant Women: A feasibility study of Food Acquisition Management Guide
Scientific Title:Acronym A feasibility study of food maquisition management guide for pregnant women as education materials
Region
Japan

Condition
Condition Low Birth Weight, anemia, Gestational Diabetes Mellitus
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the feasibility of the food acquisition management guide
Basic objectives2 Others
Basic objectives -Others Improvement of Food intake,Energy and Nutrient intake
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Food intake, Energy and Nutrient intake
Key secondary outcomes Self-efficacy regarding food availability,Usage status of teaching materials

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Personal counseling twice at 20week and 24week.Diet Diagnosis,booklet,recipe card,self-monitorling
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
20 years-old <=
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria 20years to 40years
Key exclusion criteria Person who judged by doctor
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukari Takemi
Organization Kagawa nutrition university
Division name Nutrition Ecology
Zip code
Address 3-9-21 Chiyoda Sakado Saitama
TEL 049-282-3721
Email 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 049-282-3721
Homepage URL
Email ukb161@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition University
Institute
Department

Funding Source
Organization Kagawa Nutrition University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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)
山王クリニック(埼玉県)
大野医院(栃木県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2017 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033384

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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