Can a custom coaching program slow liver damage?
NCT ID NCT05196867
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests whether a personalized, behavior-based program can help people with early liver disease (fatty liver or scarring) manage their condition better than standard care. About 49 adults with risk factors like obesity or diabetes are taking part. The goal is to see if the program lowers a blood marker of liver scarring over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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49 people
The number who actually took part.
- Started
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Feb 2022
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1\. Evidence of steatosis (CAP score ≥ 290 by vibration controlled transient elastography) OR Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography \[F2 score ≥ 8kPa\]) AND meets one of the following criteria: i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), OR ii. presence of type II diabetes mellitus, OR iii. lean/normal weight with presence of at least two metabolic risk abnormalities, OR: 1. Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups) 2. Blood pressure ≥130/85 mmHg or specific drug treatment 3. Plasma triglycerides ≥150 mg/dl or specific drug treatment 4. Plasma HDL-cholesterol \<40 mg/dl for men and \<50 mg/dl for women, or specific drug treatment 5. Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15 AND/OR 2. Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography) and presence of one of the following: 1. chronic HBV (HBsAg+ or taking anti-HBV therapy), or 2. chronic HCV (1. detectable HCV RNA \> 4 months or a 2. history of HCV infection and taking anti-HCV therapy) 3\. At least 18 years old 4. Speak and read English or Spanish 5. Access to smartphone with data plan or Wi-Fi access 6. Willing to receive up to 12 text messages per week Exclusion Criteria: 1. Pregnant or planning to become pregnant in next 12 months (by self-report) 2. Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet 3. Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet 4. Current or prior history of primary liver cancer or cancer that is metastatic to the liver 5. AUDIT-10 score \>15 6. Family or household member already enrolled into study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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