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

University of Michigan75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis

Interventions

Usual Care then FitBitOTHER

Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).

FitBit then Usual CareOTHER

Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score

CAP score is generated by a fibroscan. Scores are reported in dB/M ranging from 100-400, with lower scores indicating less hepatic steatosis (Liver fat). Percent change is calculated by (baseline CAP minus follow up CAP) divided by baseline CAP 12 month data, originally planned to assess values after crossover is not presented because no participants completed crossover participation.

Time frame: Baseline, 6 months,

Secondary Outcomes

Percent Change in Body Weight

Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline

Time frame: Baseline, 6 months

Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)

The IPAQ is a validated questionnaire that obtains information on days and minutes per week of different types of physical activity. Scores range from 0 - 500. Score at 6 months minus score at baseline determines change in IPAQ score. A negative change means less physcially active and a positive change means more physically active. Insufficient paired results existed to provide percent change measurements. Medians overall are provided.

Time frame: Baseline, 6 months

Data from ClinicalTrials.gov

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