UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006377
Receipt number R000007570
Scientific Title DIetetics student's Education and Training wIth Conversation map for dIAbetes and Nutrition planning study
Date of disclosure of the study information 2011/09/20
Last modified on 2020/03/27 10:21:53

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Basic information

Public title

DIetetics student's Education and Training wIth Conversation map for dIAbetes and Nutrition planning study

Acronym

DIETICIAN study (DIetetics student's Education and Training wIth Conversation map for dIAbetes and Nutrition planning study)

Scientific Title

DIetetics student's Education and Training wIth Conversation map for dIAbetes and Nutrition planning study

Scientific Title:Acronym

DIETICIAN study (DIetetics student's Education and Training wIth Conversation map for dIAbetes and Nutrition planning study)

Region

Japan


Condition

Condition

Diabetes mellitus

Classification by specialty

Endocrinology and Metabolism Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The Conversation Map is a novel educational tool for patients with diabetes. The methodology also is reported to be effective on training of diabetesnursing elective course, suggesting that the Conversation Map is a beneficial tool for education of students. We have then conducted a prospective study to evaluateeducational effect on understanding of diabetes and nutrition guidance in dietetic students.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changing in general knowledge of diabetes

Key secondary outcomes

1)Changing in nutrition guidance planning
2)Changing in knowledge of diet
3)Changing in knowledge of exercise


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Conversation map group

Interventions/Control_2

Lecture group

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

18 years-old <=

Age-upper limit

25 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Students takingthe clinical field practice in Kyoto University Hospital
2.Students having primary knowledge of diabetes
3.Students having no background in Conversation map
4.Writteninformed consent

Key exclusion criteria

1.Visual deficits
2.Severe depression or severe psychological condition

Target sample size

28


Research contact person

Name of lead principal investigator

1st name Nobuya
Middle name
Last name INAGAKI

Organization

Kyoto University Hospital

Division name

Diabetes and Clinical Nutrition

Zip code

606-8507

Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN

TEL

075-753-4300

Email

inagaki@metab.kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Nahoko/ Shinichi
Middle name
Last name MIZUNO / HARASHIMA

Organization

Kyoto University Hospital

Division name

Metabolism and Clinical Nutrition / Diabetes and Clinical Nutrition

Zip code

606-8507

Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN

TEL

075-366-7630

Homepage URL


Email

mizuno_n@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital
Metabolism and Clinical Nutrition

Institute

Department

Personal name



Funding Source

Organization

Kyoto University Hospital

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

Kyoto University Hospital

Address

54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City

Tel

075-366-7630

Email

mizuno_n@kuhp.kyoto-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

E1219

Org. issuing International ID_1

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 20 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

Terminated

Date of protocol fixation

2011 Year 08 Month 29 Day

Date of IRB

2011 Year 07 Month 05 Day

Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2014 Year 09 Month 30 Day

Date of closure to data entry

2014 Year 09 Month 30 Day

Date trial data considered complete


Date analysis concluded

2020 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 09 Month 20 Day

Last modified on

2020 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007570


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name