NCT05196867

Brief Summary

To determine the effectiveness of a behaviorally-based tailored disease management intervention in patients with fibrosis or steatosis and risk factors for cirrhosis.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
27mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Feb 2022Aug 2028

First Submitted

Initial submission to the registry

December 29, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2028

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

6.6 years

First QC Date

December 29, 2021

Last Update Submit

February 20, 2026

Conditions

Liver DiseasesFibrosis, LiverCirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

  • Change in FIB-4 score

    a serum-based biomarker of fibrosis

    up to 6 months

Study Arms (2)

Arm 1: Immediate Intervention

EXPERIMENTAL

participants will receive the 6 months intervention immediately

Behavioral: Intervention Group

Arm 2: Delayed Intervention

EXPERIMENTAL

participants will receive the intervention after the 6-month follow-up visit

Behavioral: Control Group

Interventions

Intervention GroupBEHAVIORAL

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.

Arm 1: Immediate Intervention
Control GroupBEHAVIORAL

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.

Arm 2: Delayed Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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
  • 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)
  • \. 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Liver DiseasesLiver Cirrhosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Digestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Karen Basen-Engquist, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2021

First Posted

January 19, 2022

Study Start

February 11, 2022

Primary Completion (Estimated)

August 30, 2028

Study Completion (Estimated)

August 30, 2028

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

US(1)