Status:
COMPLETED
Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Noom Inc.
Conditions:
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There is a clear unmet clinical need for effective lifestyle intervention in patients with nonalcoholic steatohepatitis (NASH). Patients have self-identified multiple barriers to effective lifestyle i...
Eligibility Criteria
Inclusion
- Adults age \>18 years
- NASH defined as:
- Liver biopsy with evidence of steatohepatitis (NAS \>=4) or;
- Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following:
- Fibroscan kPa \>8.2 or;
- FAST \> 0.35 or;
- FIB-4 \>= 1.45 or;
- Possession of a smartphone
Exclusion
- Active or recent (\<90 days) participation in lifestyle intervention program, including weight-loss program
- Active weight-loss supplement use
- Cirrhosis
- Inability to provide informed consent
- Institutionalized/prisoner
- Other chronic liver disease (e.g., viral hepatitis)
- Recent Noom use (\<180 days)
- Secondary cause of hepatic steatosis, including significant alcohol consumption (men \>30g/d, women \>20g/d)
- Severe medical comorbidities/psychiatric illness at the discretion of the study PI
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04872777
Start Date
June 8 2021
End Date
February 10 2022
Last Update
March 2 2022
Active Locations (1)
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1
Penn State Hershey Medical Center
Marietta, Pennsylvania, United States, 17547