UMIN-CTR Clinical Trial

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
Institute	Kyoto University Hospital Metabolism and Clinical Nutrition
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007570