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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839082
• Other study ID #: HUM00153750
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: February 26, 2021

Study information

• Verified date: April 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 26, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

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

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	American Association for the Study of Liver Diseases

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 months,
Secondary	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	Baseline, 6 months
Secondary	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.	Baseline, 6 months