Liver DiseasesNCT05196867
Liver Cancer Prevention Randomized Control Trial
A study testing Intervention Group in people with Liver Diseases and Fibrosis, Liver, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Fibrosis, Liver, Cirrhosis, Liver
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)
- Blood pressure ≥130/85 mmHg or specific drug treatment
- Plasma triglycerides ≥150 mg/dl or specific drug treatment
- Plasma HDL-cholesterol <40 mg/dl for men and <50 mg/dl for women, or specific drug treatment
- 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
Show all 10Show fewer
- 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:
- chronic HBV (HBsAg+ or taking anti-HBV therapy), or
- 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
Who cannot join
- Pregnant or planning to become pregnant in next 12 months (by self-report)
- Medical contraindications to home-based exercise or low-fat, high-vegetable-and-fruit diet
- Recent or planned surgery that would interfere with home-based exercise or a low-fat, high vegetable and fruit diet
- Current or prior history of primary liver cancer or cancer that is metastatic to the liver
- AUDIT-10 score >15
- Family or household member already enrolled into study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease
To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.
Read the detailed description
Hypothesis: A technology-assisted self-management intervention that addresses diet, physical activity, alcohol use, and medication adherence can produce regression in fibrosis as measured by FIB-4 in patients with fibrosis or steatosis and risk factors for cirrhosis, including chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, alcohol use, or non-alcoholic fatty liver disease (NAFLD).
Primary objective:
To test the effect of the behavioral intervention on fibrosis in a randomized trial. We will randomize eligible HOPE Clinic patients to (i) a 6-month self-management intervention to help participants implement behavioral changes to manage their disease or (ii) a wait-list control group that will receive the intervention after their 6-month assessment.
Secondary objective:
Evaluate changes in behavioral risk factors for liver fibrosis or steatosis (body composition, physical activity, diet, medication adherence, alcohol use), metabolic syndrome, and patient activation and other behavioral determinants.
- Conditions
- Liver Diseases, Fibrosis, Liver, Cirrhosis, Liver
- Being tested
- Intervention Group, Control Group
- Medical subject headings
- Liver Diseases, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
Participants in the intervention group will receive (1) weekly telephone or videoconference coaching; (2) health education print materials and tip sheets;(3) navigation to programs and resources to help participants meet behavioral goals (e.g., fitness events, classes and webinars, etc); (4) text messages related to behavioral skills; (5) a Fitbit activity tracker and Aria scale; (6) resistance tubes and instructional video for strengthening exercise (if resistance exercise module is chosen); and (7) tools to manage portion sizes.
Control GroupBehavioural
Patients in the control arm will initially receive written education material about the risk factors for liver cancer and management options. They will be offered the intervention after they complete the 6-month assessment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Immediate Intervention | Experimental | participants will receive the 6 months intervention immediately Receives: Behavioral: Intervention Group |
| Arm 2: Delayed Intervention | Experimental | participants will receive the intervention after the 6-month follow-up visit Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FIB-4 score
a serum-based biomarker of fibrosis
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start11 Feb 2022
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- Karen Basen-Engquist, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196867
- Sponsor's protocol ID
- 2021-1015
- Other IDs
- NCI-2021-14391
- Status last verified
- Aug 2026
- First submitted
- 29 Dec 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease
- ClinicalTrials.gov ID
- NCT05196867
- Acronym / sponsor ID
- 2021-1015
- Conditions
- Liver Diseases, Fibrosis, Liver, Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.
Detailed description
Hypothesis: A technology-assisted self-management intervention that addresses diet, physical activity, alcohol use, and medication adherence can produce regression in fibrosis as measured by FIB-4 in patients with fibrosis or steatosis and risk factors for cirrhosis, including chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, alcohol use, or non-alcoholic fatty liver disease (NAFLD).
Primary objective:
To test the effect of the behavioral intervention on fibrosis in a randomized trial. We will randomize eligible HOPE Clinic patients to (i) a 6-month self-management intervention to help participants implement behavioral changes to manage their disease or (ii) a wait-list control group that will receive the intervention after their 6-month assessment.
Secondary objective:
Evaluate changes in behavioral risk factors for liver fibrosis or steatosis (body composition, physical activity, diet, medication adherence, alcohol use), metabolic syndrome, and patient activation and other behavioral determinants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Immediate Intervention | Experimental | Behavioral: Intervention Groupparticipants will receive the 6 months intervention immediately |
| Arm 2: Delayed Intervention | Experimental | Behavioral: Control Groupparticipants will receive the intervention after the 6-month follow-up visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)
- Blood pressure ≥130/85 mmHg or specific drug treatment
- Plasma triglycerides ≥150 mg/dl or specific drug treatment
- Plasma HDL-cholesterol <40 mg/dl for men and <50 mg/dl for women, or specific drug treatment
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupParticipants in the intervention group will receive (1) weekly telephone or videoconference coaching; (2) health education print materials and tip sheets;(3) navigation to programs and resources to help participants meet behavioral goals (e.g., fitness events, classes and webinars, etc); (4) text messages related to behavioral skills; (5) a Fitbit activity tracker and Aria scale; (6) resistance tubes and instructional video for strengthening exercise (if resistance exercise module is chosen); and (7) tools to manage portion sizes. | Behavioural | Arm 1: Immediate Intervention |
| Control GroupPatients in the control arm will initially receive written education material about the risk factors for liver cancer and management options. They will be offered the intervention after they complete the 6-month assessment. | Behavioural | Arm 2: Delayed Intervention |
Primary outcome
Change in FIB-4 score
Time frame: up to 6 months
a serum-based biomarker of fibrosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Basen-Engquist, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Liver Diseases and Fibrosis, Liver, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FIB-4 score (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.