Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

Non-alcoholic Steatohepatitis Clinical Trial

Official title:

Mobile Health Delivered Lifestyle Intervention Program in Patients With Nonalcoholic Steatohepatitis: A Proof of Concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872777
• Other study ID #: STUDY00017544
• Status: Completed
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: March 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 intervention can be removed with a mobile health (mHealth) platform.

This study will be a proof of concept study to evaluate weight loss efficacy of Noom Healthy Weight (HW), a mHealth lifestyle intervention, in patients with NASH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Behavioral:
• Noom Healthy Weight
Following study group assignment, the following procedures will be completed for the Noom HW mHealth lifestyle intervention: Noom application set-up and troubleshooting on smartphone (license provided) Digital scale provision (subjects may keep the scale) Capture of available clinical information over preceding 28-days.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Marietta	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Noom Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Change in self-measured body weight	16 weeks
Secondary	liver enzymes	Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP))	16 weeks
Secondary	Noom healthy weight engagement	Feasibility will be assessed according to user engagement. Engaged users are defined as those who complete at least one meaningful in-application action per week (e.g., weight log, food log, exercise log, article read).	16 weeks
Secondary	Glucose	Change in blood glucose mg/dL	16 weeks
Secondary	hemoglobin A1c	Change hemoglobin A1c (%)	16 weeks
Secondary	Cholesterol level	Change in cholesterol mg/dL	16 weeks
Secondary	NAFLD Fibrosis Score	change in NAFLD Fibrosis Score	16 weeks
Secondary	IgA level	Change in IgA level mg/dL	16 weeks
Secondary	Ferritin	Change in Ferritin ng/mL	16 weeks
Secondary	histology	Change in transient elastography or liver histology	16 weeks