UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035430 |
|---|---|
| Receipt number | R000040363 |
| Scientific Title | A prospective single-center study to evaluate the feasibility of motivation management by wearable fitness devices and smart phone application to influence the clinical manifestation of non-alcoholic fatty liver disease (NAFLD) (OCUN-1) |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2021/07/06 11:10:59 |
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Basic information
Public title
A prospective single-center study to evaluate the feasibility of motivation management by wearable fitness devices and smart phone application to influence the clinical manifestation of non-alcoholic fatty liver disease (NAFLD) (OCUN-1)
Acronym
Usefulness of motivation management for the clinical manifestation of NAFLD
Scientific Title
A prospective single-center study to evaluate the feasibility of motivation management by wearable fitness devices and smart phone application to influence the clinical manifestation of non-alcoholic fatty liver disease (NAFLD) (OCUN-1)
Scientific Title:Acronym
Usefulness of motivation management for the clinical manifestation of NAFLD
Region
| Japan |
Condition
Condition
Non-alcoholic fatty liver disease (NAFLD)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of improving controlled attenuation parameter (CAP) before and after the examination by enforcing diet and exercise therapy (aerobic + resistance exercise) under a motivation control using wearable fitness devices and a smartphone application for 4 months for patients with NAFLD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change rate of controlled attenuation parameter (CAP) by Fibroscan 4 months after starting the test.
Key secondary outcomes
1. Change rate of ALT value and insulin resistance (HOMA-IR) 4 months after the start of the test.
2. Change rate of adipocytokine (TNF-alpha, leptin, adiponectin) and myoctane (irisin, myostatin, follistatin) 4 months after the start of the test.
3. Change rate of body weight, body fat composition, and hepatic elasticity.
4. Change rate of FIB-4 index, 4 type collagen 7S, CK-18 fragment, and pro-C3 4 months after starting the test.
5. Achievement of diet and exercise therapy.
6. The rate of change between the continuation group and the discontinuation group at the time of the follow-up inspection of each factor of 1-5.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Motivation management by wearable fitness devices and smart phone application(4 months)
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who have fatty liver by abdominal ultrasonography or abdominal CT.
2. Non-drinkers (alcohol consumption is pure alcohol and men 30 g / day, females less than 20 g / day).
3. Patients who got adequate explanation when participating in this study, fully understand and obtained document consent by the patient's free will.
Key exclusion criteria
1. HCV antibody and HBs antigen positive patients.
2. Patients who screened ANA, AMA-M2 antibody, IgG, IgM, etc. and autoimmune diseases (autoimmune hepatitis, primary biliary cholangitis, etc.) can not be excluded.
3. Patient with drug-induced liver injury.
4. Patients with metabolic liver disease (hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency etc.)
5. Patients with severe heart disease (unstable angina, acute heart failure, severe valvular disease, severe arrhythmia, active myocarditis, moderate aortic aneurysm, severe hypertension and thrombophlebitis).
6. Patients with acute systemic disease or fever.
7. Patients with severe cirrhosis (Child-Pugh score B or C).
8. Patients with severe kidney disease (BUN 25 mg / dL or more or serum creatinine 2.0 mg / dL or more).
9. Patients who judged unsuitable as subjects by doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Fujii |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Hepatology
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno, Osaka
TEL
0666453905
rolahideki@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Fujii |
Organization
Graduate School of Medicine, Osaka City University
Division name
Department of Hepatology
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno
TEL
0666453905
Homepage URL
rolahideki@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Hepatology, Graduate School of Medicine, Osaka City Universit.
Institute
Department
Personal name
Funding Source
Organization
Donatiom
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
The Ethical Committee of Osaka City University Graduate School of Medicine
Address
1-4-3, Asahimachi, Abeno, Osaka
Tel
06-6645-3456
ethics@med.osaka-cu.ac.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
| 2019 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 01 | Month | 03 | Day |
Last modified on
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040363
