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A single-center, prospective, open-label, randomized, comparative, and placebocontrolled observation study for effect of using Mobile App-based Human Coaching Program on NAFLD

A single-center, prospective, open-label, randomized, comparative, and placebocontrolled observation study for effect of using Mobile App-based Human Coaching Program on NAFLD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007695
Enrollment
100
Registered
2022-09-15
Start date
2021-09-13
Completion date
Unknown
Last updated
2022-10-24

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

Conditions

None listed

Interventions

Behavioral : Both the test and control groups will receive the same visit schedule and the same standard of care. However, in the case of the test group, the only difference is that the coaching progr

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female aged 19 years or older and under 65 years of age at the time of writing the written consent 2. Patients diagnosed with NAFLD (non-alcoholic fatty liver disease) as a result of ultrasound examination 3. Patients diagnosed with fatty liver (CAP value >238 dB/m) by transient elastography 4. Those who voluntarily consented in writing to the research

Exclusion criteria

Exclusion criteria: 1. Patients who meet the criteria for alcoholic fatty liver disease (in case of exceeding 210 g per week for men and 140 g per week for women for the past 2 years) 2. Patients with liver disease other than fatty liver 3. Cirrhosis patients with reduced liver function (CTP class B and C) 4. Those taking drugs that can cause fatty liver (thiazolidinedione, SGLT2i class, amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.) 5. Patients treated with oral or parenteral corticosteroids chronically (>14 consecutive days) within 8 weeks prior to screening 6. Patients with malnutrition, starvation, debilitating conditions (including patients with severe infections and severe trauma before and after surgery), pituitary insufficiency or adrenal insufficiency 7. Patients receiving or receiving radiation and chemotherapy for malignant tumors for less than 2 years 8. Patients undergoing gastrointestinal bypass 9. Heart failure (class III-IV in NYHA classification) or uncontrolled arrhythmias within 6 months 10. Those with acute cardiovascular disease within 12 weeks (Patients with a history of unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or coronary intervention) 11. Patients with renal failure, chronic renal disease (estimated glomerular filtration rate <60 mL/min/1.73 m2) or patients on dialysis 12. Anemic patients with an Hb level of less than 10.5 g/dL 13. Others who are unable to participate in the research due to the judgment of the researcher 14. Persons unable to read consent forms (eg illiterate, foreigners, etc.)

Design outcomes

Primary

MeasureTime frame
Changes in the amount of fatty liver (CAP Value) within and between groups compared to baseline after 12 and 24 weeks of treatment

Secondary

MeasureTime frame
Steatosis Grade change through changes in the amount of fatty liver (CAP Value) within and between groups compared to baseline after 12 and 24 weeks of treatment;Changes in Liver stiffness values within and between groups compared to baseline after 12 and 24 weeks of treatment;Fibrosis Grade through changes in Liver stiffness within and between groups compared to baseline after 12 and 24 weeks of treatment;After 12 and 24 weeks of treatment, AST and ALT (<40IU /L)/ change and normalization ratio within and between groups compared to baseline;Change and normalization ratio of total bilirubin / prothrombin time (INR) within and between groups compared to baseline after 12 and 24 weeks of treatment;Changes and normalization ratio of LDL-C/HDL-C/TG(Triglycerides)/Total Cholesterol within and between groups compared to baseline after 12 and 24 weeks of treatment;After 12 and 24 weeks of treatment, the rate of change and decrease in fasting blood glucose levels within and between groups compared to baseline (<100) (in case of subjects with diabetes);After 12 and 24 weeks of treatment, the rate of change and decrease in HbA1c levels within and between groups compared to baseline (<5.5) (in case of subjects with diabetes);Changes in insulin levels within and between groups compared to baseline after 12 and 24 weeks of treatment;Changes in body fat mass within and between groups compared to baseline after 12 and 24 weeks of treatment;Changes in muscle mass within and between groups compared to baseline after 12 and 24 weeks of treatment

Countries

Korea, Republic of

Contacts

Public ContactSeung Up Kim

Yonsei University Health System, Severance Hospital

ksukorea@yuhs.ac+82-2-393-6884

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026