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History of Changes for Study: NCT04872777
Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH
Latest version (submitted March 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 3, 2021 None (earliest Version on record)
2 July 13, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 March 1, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT04872777
Submitted Date:  May 3, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: STUDY00017544
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2021
Overall Status: Not yet recruiting
Study Start: June 1, 2021
Primary Completion: June 1, 2023 [Anticipated]
Study Completion: June 1, 2024 [Anticipated]
First Submitted: April 28, 2021
First Submitted that
Met QC Criteria:
May 3, 2021
First Posted: May 5, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
May 3, 2021
Last Update Posted: May 5, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Milton S. Hershey Medical Center
Responsible Party: Principal Investigator
Investigator: Jonathan Stine
Official Title: Director of Research, Penn State Liver Center, Assistant Professor of Medicine and Public Health Sciences
Affiliation: Milton S. Hershey Medical Center
Collaborators: Noom Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.

Detailed Description:
Open or close this module Conditions
Conditions: Non-alcoholic Steatohepatitis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Gloriany Rivas, BA
Telephone: 7175310003 Ext. 320223
Email: grivas@pennstatehealth.psu.edu
Study Officials: Jonathan G Stine, MD
Principal Investigator
Milton S. Hershey Medical Center
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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