Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

Not Applicable

Completed

• Conditions: Non-alcoholic Steatohepatitis
• Interventions: Behavioral: Noom Healthy Weight

• Registration Number: NCT04872777
• Lead Sponsor: Milton S. Hershey Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-05
• Study Start: 2021-06-08
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noom Healthy Weight	Noom Healthy Weight	Following study group assignment, the following procedures will be completed for the Noom HW mHealth lifestyle intervention: 1. Noom application set-up and troubleshooting on smartphone (license provided) 2. Digital scale provision (subjects may keep the scale) 3. Capture of available clinical information over preceding 28-days.

Primary Outcome Measures

Name	Time	Method
Weight	16 weeks	Change in self-measured body weight

Secondary Outcome Measures

Name	Time	Method
hemoglobin A1c	16 weeks	Change hemoglobin A1c (%)
histology	16 weeks	Change in transient elastography or liver histology
liver enzymes	16 weeks	Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP))
NAFLD Fibrosis Score	16 weeks	change in NAFLD Fibrosis Score
Noom healthy weight engagement	16 weeks	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).
Glucose	16 weeks	Change in blood glucose mg/dL
Cholesterol level	16 weeks	Change in cholesterol mg/dL
Ferritin	16 weeks	Change in Ferritin ng/mL
IgA level	16 weeks	Change in IgA level mg/dL

Trial Locations

Locations (1)

Penn State Hershey Medical Center; 🇺🇸 Marietta, Pennsylvania, United States