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)

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) - Usefulness of motivation management for the clinical manifestation of NAFLD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035430

Enrollment

Registered

2019-02-01

Start date

2019-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease (NAFLD)

Interventions

Motivation management by wearable fitness devices and smart phone application(4 months)

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change rate of controlled attenuation parameter (CAP) by Fibroscan 4 months after starting the test.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactHideki Fujii

Graduate School of Medicine, Osaka City University Department of Hepatology

rolahideki@med.osaka-cu.ac.jp0666453905

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026