Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

• ClinicalTrials.gov Identifier: NCT04872777
• Recruitment Status: Completed
• First Posted: May 5, 2021
• Last Update Posted: March 2, 2022
• Sponsor: Milton S. Hershey Medical Center
• Collaborator: Noom Inc.
• Information provided by (Responsible Party): Jonathan Stine, Milton S. Hershey Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-alcoholic Steatohepatitis	Behavioral: Noom Healthy Weight	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Forty-subjects with NASH will be randomized 1:1 to either receive Noom HW mHealth lifestyle intervention or standard clinical care.
• Primary Purpose: Treatment
• Official Title: Mobile Health Delivered Lifestyle Intervention Program in Patients With Nonalcoholic Steatohepatitis: A Proof of Concept Study
• Actual Study Start Date: June 8, 2021
• Actual Primary Completion Date: February 10, 2022
• Actual Study Completion Date: February 10, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Weight [ Time Frame: 16 weeks ]
   Change in self-measured body weight

Secondary Outcome Measures :

1. liver enzymes [ Time Frame: 16 weeks ]
   Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP))
2. Noom healthy weight engagement [ Time Frame: 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).
3. Glucose [ Time Frame: 16 weeks ]
   Change in blood glucose mg/dL
4. hemoglobin A1c [ Time Frame: 16 weeks ]
   Change hemoglobin A1c (%)
5. Cholesterol level [ Time Frame: 16 weeks ]
   Change in cholesterol mg/dL
6. NAFLD Fibrosis Score [ Time Frame: 16 weeks ]
   change in NAFLD Fibrosis Score
7. IgA level [ Time Frame: 16 weeks ]
   Change in IgA level mg/dL
8. Ferritin [ Time Frame: 16 weeks ]
   Change in Ferritin ng/mL
9. histology [ Time Frame: 16 weeks ]
   Change in transient elastography or liver histology

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Penn State Hershey Medical Center

Marietta, Pennsylvania, United States, 17547

Sponsors and Collaborators

Milton S. Hershey Medical Center

Noom Inc.

Investigators

• Principal Investigator: Jonathan G Stine, MD; Milton S. Hershey Medical Center

More Information

• Responsible Party: Jonathan Stine, Director of Research, Penn State Liver Center, Assistant Professor of Medicine and Public Health Sciences, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT04872777
• Other Study ID Numbers: STUDY00017544
• First Posted: May 5, 2021
• Last Update Posted: March 2, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Diseases; Digestive System Diseases