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Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

Primary Purpose

Non-alcoholic Steatohepatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noom Healthy Weight
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care

Noom Healthy Weight

Arm Description

Standard of care (SOC) control condition: Following study group assignment, the following procedures will be completed for SOC control: Digital scale provision (subjects may keep the scale) Reinforcement of need to comply with SOC treatment as directed by their NASH clinician Capture of available clinical information over preceding 28-days.

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.

Outcomes

Primary Outcome Measures

Weight
Change in self-measured body weight

Secondary Outcome Measures

liver enzymes
Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP))
Noom healthy weight engagement
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
Change in blood glucose mg/dL
hemoglobin A1c
Change hemoglobin A1c (%)
Cholesterol level
Change in cholesterol mg/dL
NAFLD Fibrosis Score
change in NAFLD Fibrosis Score
IgA level
Change in IgA level mg/dL
Ferritin
Change in Ferritin ng/mL
histology
Change in transient elastography or liver histology

Full Information

First Posted
April 28, 2021
Last Updated
March 1, 2022
Sponsor
Milton S. Hershey Medical Center
Collaborators
Noom Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04872777
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Noom Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care (SOC) control condition: Following study group assignment, the following procedures will be completed for SOC control: Digital scale provision (subjects may keep the scale) Reinforcement of need to comply with SOC treatment as directed by their NASH clinician Capture of available clinical information over preceding 28-days.
Arm Title
Noom Healthy Weight
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Noom Healthy Weight
Intervention Description
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 Outcome Measure Information:
Title
Weight
Description
Change in self-measured body weight
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
liver enzymes
Description
Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP))
Time Frame
16 weeks
Title
Noom healthy weight engagement
Description
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).
Time Frame
16 weeks
Title
Glucose
Description
Change in blood glucose mg/dL
Time Frame
16 weeks
Title
hemoglobin A1c
Description
Change hemoglobin A1c (%)
Time Frame
16 weeks
Title
Cholesterol level
Description
Change in cholesterol mg/dL
Time Frame
16 weeks
Title
NAFLD Fibrosis Score
Description
change in NAFLD Fibrosis Score
Time Frame
16 weeks
Title
IgA level
Description
Change in IgA level mg/dL
Time Frame
16 weeks
Title
Ferritin
Description
Change in Ferritin ng/mL
Time Frame
16 weeks
Title
histology
Description
Change in transient elastography or liver histology
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan G Stine, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Marietta
State/Province
Pennsylvania
ZIP/Postal Code
17547
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

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