Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

Penn State Health

Status: Completed

Conditions: Non-alcoholic Steatohepatitis

Treatments: Behavioral: Noom Healthy Weight

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04872777

STUDY00017544

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard of care

No Intervention group

Description:

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.

Noom Healthy Weight

Experimental group

Description:

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.

Treatment:

Behavioral: Noom Healthy Weight