Non-alcoholic Steatohepatitis
Conditions
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.
Interventions
BEHAVIORALNoom 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.
Sponsors
Noom Inc.
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Forty-subjects with NASH will be randomized 1:1 to either receive Noom HW mHealth lifestyle intervention or standard clinical care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 16 weeks | Change in self-measured body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Noom healthy weight engagement | 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 | 16 weeks | Change in blood glucose mg/dL |
| hemoglobin A1c | 16 weeks | Change hemoglobin A1c (%) |
| Cholesterol level | 16 weeks | Change in cholesterol mg/dL |
| liver enzymes | 16 weeks | Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP)) |
| IgA level | 16 weeks | Change in IgA level mg/dL |
| Ferritin | 16 weeks | Change in Ferritin ng/mL |
| histology | 16 weeks | Change in transient elastography or liver histology |
| NAFLD Fibrosis Score | 16 weeks | change in NAFLD Fibrosis Score |
Countries
United States
Outcome results
None listed