Clinical trial · Interventional
Liver Cancer Prevention Randomized Control Trial
A Randomized, Prospective Study of a Behaviorally-based Tailored Disease Management Intervention vs Control in Patients With Risk Factors for Liver Disease
NCT05196867CI-TRIAL-00121591active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis, Liver | — | UNRESOLVED | — |
| Fibrosis, Liver | — | UNRESOLVED | — |
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Group | Behavioral | — | UNRESOLVED |
| Intervention Group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Immediate Intervention
- description
- participants will receive the 6 months intervention immediately
- interventionNames
- Behavioral: Intervention Group
- type
- EXPERIMENTAL
- label
- Arm 2: Delayed Intervention
- description
- participants will receive the intervention after the 6-month follow-up visit
- interventionNames
- Behavioral: Control Group
Primary outcomes (1)
- measure
- Change in FIB-4 score
- timeFrame
- up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.