Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

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

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.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Steatohepatitis
• Intervention / Treatment: Behavioral: Noom Healthy Weight

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Marietta, Pennsylvania, United States, 17547
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Noom Inc.
• Investigators: Principal Investigator: Jonathan G Stine, MD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: STUDY00017544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No