UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029655
Receipt number R000033887
Scientific Title Investigation about nutritional education for the utilization by special labeling diet
Date of disclosure of the study information 2017/10/22
Last modified on 2017/10/22 15:35:07

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Basic information

Public title

Investigation about nutritional education for the utilization by special labeling diet

Acronym

Investigation about nutritional education for the utilization by special labeling diet

Scientific Title

Investigation about nutritional education for the utilization by special labeling diet

Scientific Title:Acronym

Investigation about nutritional education for the utilization by special labeling diet

Region

Japan


Condition

Condition

inadequate nutrition

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of the nutritional education technique for which a nutritional special label diet is used.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Effective educational method

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Study meeting by a professional of nutrition

Interventions/Control_2

Study meeting by a non-professional of nutrition

Interventions/Control_3

Self study used by educational medium

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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The person who can take orally.

Key exclusion criteria

The person who can not take orally.

Target sample size

450


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Takahashi

Organization

Tokushima University

Division name

Department of Preventive Enviroment and Nutrition

Zip code


Address

Kuramoto-cho 3-18-15, Tokushima City, Tokushima

TEL

088-633-9428

Email

akiratak@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Takahashi

Organization

Tokushima University

Division name

Department of Preventive Enviroment and Nutrition

Zip code


Address

Kuramoto-cho 3-18-15, Tokushima City, Tokushima

TEL

088-633-9428

Homepage URL


Email

akiratak@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University

Institute

Department

Personal name



Funding Source

Organization

Tokushima University

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


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



Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 22 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 23 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 22 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 10 Month 22 Day

Last modified on

2017 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033887


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name