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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Penn State Hershey Medical Center
Marietta, Pennsylvania, United States
Weight
Change in self-measured body weight
Time frame: 16 weeks
liver enzymes
Change in liver enzymes units per liter (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP))
Time frame: 16 weeks
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).
Time frame: 16 weeks
Glucose
Change in blood glucose mg/dL
Time frame: 16 weeks
hemoglobin A1c
Change hemoglobin A1c (%)
Time frame: 16 weeks
Cholesterol level
Change in cholesterol mg/dL
Time frame: 16 weeks
NAFLD Fibrosis Score
change in NAFLD Fibrosis Score
Time frame: 16 weeks
IgA level
Change in IgA level mg/dL
Time frame: 16 weeks
Ferritin
Change in Ferritin ng/mL
Time frame: 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
histology
Change in transient elastography or liver histology
Time frame: 16 weeks