Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-alcoholic Steatohepatitis

Intervention / Treatment
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* Behavioral: Noom Healthy Weight


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Standard of care (SOC) control condition: Following study group assignment, the following procedures will be completed for SOC control: Digital scale provision (subjects may keep the scale) Reinforcement of need to comply with SOC treatment as directed by their NASH clinician Capture of available clinical information over preceding 28-days. | |
| Experimental: Noom Healthy Weight<br>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. | Behavioral: Noom Healthy Weight<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in self-measured body weight | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver enzymes | Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP)) | 16 weeks | 
| 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 | 
| Glucose | Change in blood glucose mg/dL | 16 weeks | 
| hemoglobin A1c | Change hemoglobin A1c (%) | 16 weeks | 
| Cholesterol level | Change in cholesterol mg/dL | 16 weeks | 
| NAFLD Fibrosis Score | change in NAFLD Fibrosis Score | 16 weeks | 
| IgA level | Change in IgA level mg/dL | 16 weeks | 
| Ferritin | Change in Ferritin ng/mL | 16 weeks | 
| histology | Change in transient elastography or liver histology | 16 weeks |