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Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04872777
Recruitment Status : Completed
First Posted : May 5, 2021
Last Update Posted : March 2, 2022
Sponsor:
Collaborator:
Noom Inc.
Information provided by (Responsible Party):
Jonathan Stine, Milton S. Hershey Medical Center

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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:

  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.
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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872777


Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Marietta, Pennsylvania, United States, 17547
Sponsors and Collaborators
Milton S. Hershey Medical Center
Noom Inc.
Investigators
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Principal Investigator: Jonathan G Stine, MD Milton S. Hershey Medical Center
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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    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases