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

Tracking Information

• First Submitted Date: April 28, 2021
• First Posted Date: May 5, 2021
• Last Update Posted Date: March 2, 2022
• Actual Study Start Date: June 8, 2021
• Actual Primary Completion Date: February 10, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 3, 2021)

Weight [ Time Frame: 16 weeks ]

Change in self-measured body weight

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 3, 2021)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: 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:

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.

Study Arms

• No Intervention: Standard of care

  Standard of care (SOC) control condition: Following study group assignment, the following procedures will be completed for SOC control:

  1. Digital scale provision (subjects may keep the scale)
  2. Reinforcement of need to comply with SOC treatment as directed by their NASH clinician
  3. 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:

  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.
  Intervention: Behavioral: Noom Healthy Weight

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 3, 2021): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 10, 2022
• Actual Primary Completion Date: February 10, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04872777
• Other Study ID Numbers: STUDY00017544
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jonathan Stine, Milton S. Hershey Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Milton S. Hershey Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Noom Inc.

Investigators

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

• PRS Account: Milton S. Hershey Medical Center
• Verification Date: March 2022