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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011176
Receipt No. R000013092
Scientific Title The'Donations for Decreased ALT (D4D)' prosocial behavior incentive scheme for NAFLD patients
Date of disclosure of the study information 2013/08/01
Last modified on 2013/07/11

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Basic information
Public title The'Donations for Decreased ALT (D4D)' prosocial behavior incentive scheme for NAFLD patients
Acronym D4D project
Scientific Title The'Donations for Decreased ALT (D4D)' prosocial behavior incentive scheme for NAFLD patients
Scientific Title:Acronym D4D project
Region
Japan

Condition
Condition NAFLD
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether prosocial behaviour can become a motivating factor for the treatment of NAFLD
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes ALT decrease
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 diet therapy
Interventions/Control_2 motivation therapy
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
80 years-old >
Gender Male and Female
Key inclusion criteria NAFLD with ALT > or = 31 IU/L
Key exclusion criteria HCC, decompensated LC
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Sumida
Organization Kyoto Prefectural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kamigyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto Prefectural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
Email sumida@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 08 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
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 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
2013 Year 07 Month 11 Day
Last modified on
2013 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013092

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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