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Completed

NCT Number: NCT04872777

Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Marietta, Pennsylvania, 17547, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noom Healthy Weight

Behavioral

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.

Primary outcomes

  1. Weight

    Time frame: 16 weeks

    Change in self-measured body weight

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Noom Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 5, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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