UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051112 |
|---|---|
| Receipt number | R000058266 |
| Scientific Title | Feasibility Study of Cognitive-Behavioral Therapy for Lifestyle Change in Patients with Non-Alcoholic Fatty Liver Disease (FIT study) |
| Date of disclosure of the study information | 2023/05/20 |
| Last modified on | 2023/05/20 14:30:52 |
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Basic information
Public title
Feasibility Study of Cognitive-Behavioral Therapy for Lifestyle Change in Patients with Non-Alcoholic Fatty Liver Disease (FIT study)
Acronym
Feasibility Study of Cognitive-Behavioral Therapy for Lifestyle Change in Patients with Non-Alcoholic Fatty Liver Disease (FIT study)
Scientific Title
Feasibility Study of Cognitive-Behavioral Therapy for Lifestyle Change in Patients with Non-Alcoholic Fatty Liver Disease (FIT study)
Scientific Title:Acronym
Feasibility Study of Cognitive-Behavioral Therapy for Lifestyle Change in Patients with Non-Alcoholic Fatty Liver Disease (FIT study)
Region
| Japan |
Condition
Condition
NAFLD
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility of cognitive-behavioral therapy in patients with NAFLD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in hepatic fat levels by MRS at baseline and after 6 months
Key secondary outcomes
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive-behavioral therapy by a nurse (face-to-face/telephone)
Watch videos about exercise
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with NAFLD
2)Patients with more than 5% hepatic fat deposition in MRS
3)Patients had a BMI of 25kg/m2 or more
Key exclusion criteria
1)Patients with liver cirrhosis or hepatocellular carcinoma
2)Patients with implantable medical electrical devices such as pacemakers
3)Patients with unsuitable conditions for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Arase |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
arase@tokai-u.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Arase |
Organization
Tokai University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
arase@tokai-u.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Pfizer health research foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University School of Medicine, IRB
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
arase@tokai-u.jp
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
| 2023 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 20 | Day |
Last modified on
| 2023 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058266
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
