An interventional study of Mobile application and wearable device and Time-restricted eating in Non-Alcoholic Fatty Liver Disease, Time Restricted Feeding and Mobile Technology, sponsored by Hanyang University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Hanyang University · Not applicable, Interventional, and Treatment
In non-alcoholic fatty liver disease (NAFLD), it is established that calorie restriction is the most essential dietary modification. The time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with NAFLD. Therefore, this study aims to conduct a prospective study to determine the effect of time-restricted diet via a mobile application on the amount of intrahepatic fat and 10-year cardiovascular disease risk in patients with NAFLD.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's enrollment of 337 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Hanyang University is the lead sponsor of 52 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of both calorie restriction (500kcal below estimated energy requirement) and time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day).
Behavioral: Mobile application and wearable device · Behavioral: Time-restricted eating
This arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of only calorie restriction (500kcal below estimated energy requirement).
Behavioral: Mobile application and wearable device
Standard of care. This arm receives a brief counseling of calorie restriction.
Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity
Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)
Change in hepatic steatosis (%)
Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver
Time frame: 16 weeks
Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk
Evaluate the mean change in atherosclerotic cardiovascular disease (ASCVD) risk score (%) (high ASCVD risk score means high risk of ASCVD)
Time frame: 16 weeks
Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)
Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver
Time frame: 16 weeks
Change in body weight (kg)
Evaluate the mean change in body weight (kg)
Time frame: 16 weeks
Change in systolic blood pressure (mmHg)
Evaluate the mean change in systolic blood pressure (mmHg)
Time frame: 16 weeks
Change in low-density lipoprotein level (mg/dL)
Evaluate the mean change in low-density lipoprotein level (mg/dL)
Time frame: 16 weeks
Change in serum alanine aminotransferase level (IU/L)
Evaluate the mean change in serum alanine aminotransferase level (IU/L)
Time frame: 16 weeks
Change in hemoglobin A1c level (%)
Evaluate the mean change in hemoglobin A1c level (%)
Time frame: 16 weeks
Change in insulin sensitivity
Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: 16 weeks
Change in urine microalbumin (mcg/min)
Evaluate the mean change in urine microalbumin (mcg/min)
Time frame: 16 weeks
Change in body muscle mass (kg)
Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody)
Time frame: 16 weeks
Change in liver fibrosis by liver stiffness (kPa)
Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan®
Time frame: 16 weeks
Change in liver steatosis by controlled attenuation parameter (dB/m)
Evaluate the mean change in liver steatosis by controlled attenuation parameter (dB/m) under FibroScan®
Time frame: 16 weeks
Change in body weight (kg) at 6 months after the intervention
Evaluate the mean change in body weight (kg) at 24 weeks after the end of 16-week intervention period
Time frame: 40 weeks
Change in body weight (kg) at 12 months after the intervention
Evaluate the mean change in body weight (kg) at 48 weeks after the end of 16-week intervention period
Time frame: 64 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2023 to primary completion in Jan 2024, 11 months.
Of 357 non-industry interventional studies with no phase under Non-alcoholic Fatty Liver Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 11 months is below that.
Counting every sponsor, half of 385 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease →
Hanyang University