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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

Tracking Information
First Submitted Date  ICMJE April 28, 2021
First Posted Date  ICMJE May 5, 2021
Last Update Posted Date March 2, 2022
Actual Study Start Date  ICMJE June 8, 2021
Actual Primary Completion Date February 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2021)
Weight [ Time Frame: 16 weeks ]
Change in self-measured body weight
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Non-alcoholic Steatohepatitis
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 10, 2022
Actual Primary Completion Date February 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04872777
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Jonathan Stine, Milton S. Hershey Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Milton S. Hershey Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Noom Inc.
Investigators  ICMJE
Principal Investigator: Jonathan G Stine, MD Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP