UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029204
Receipt number 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 11:48:54

* 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

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

Obstetrics 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 or person

Institute

Kagawa Nutrition University

Institute

Department

Personal name



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

Value
https://center6.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