Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease

University of Michigan

Status: Completed

Conditions: Non-alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease

Treatments: Other: FitBit then Usual Care; Other: Usual Care then FitBit

Study type: Interventional

Funder types: Other

Identifiers

NCT03839082

HUM00153750

Details and patient eligibility

About

This study will look at physical activity and nutrition in patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). The researchers will see if providing patients with NAFLD/NASH with specific physical activity and nutrition feedback as an addition to their usual clinical care helps them to lose weight and improve liver-related parameters.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH)
• Access to mobile phone/tablet/ or computer compatible with FitBit application and ability to use said device and application
• Ability to participate in physical activity

Exclusion criteria

• Any other form of liver disease( Alcohol related liver disease; viral hepatitis, autoimmune liver disease, hereditary forms of liver disease, etc.)
• History of decompensated cirrhosis
• Plans for invasive procedures or other regimented lifestyle programs for weight reduction
• Cardiovascular event in the previous 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

75 participants in 2 patient groups

Usual Care then FitBit

Active Comparator group

Description:

This is the waitlist control arm.

Treatment:

Other: Usual Care then FitBit

Other: FitBit then Usual Care

FitBit then Usual Care

Experimental group

Description:

Intervention includes education, physical activity, and a nutrition assessment.

Treatment:

Other: Usual Care then FitBit

Other: FitBit then Usual Care