Skip to main content
OpenTrials
Completed

NCT Number: NCT03839082

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Body Weight Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Steatohepatitis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care then FitBit

Other

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

FitBit then Usual Care

Other

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

Primary outcomes

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

    Time frame: Baseline, 6 months,

    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.

Secondary outcomes

  1. Percent Change in Body Weight

    Time frame: Baseline, 6 months

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

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

    Time frame: Baseline, 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Association for the Study of Liver Diseases

Registry information

Official study title

A Randomized Controlled Pilot Trial of a Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2019
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.