N/A
N=70
Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
Non-Alcoholic Fatty Liver Disease · Non-alcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT03839082 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score — -13.0; 8.7 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual Care then FitBit (Other); FitBit then Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score |
-13.0; 8.7 | — |
| SECONDARY Percent Change in Body Weight |
NA | — |
| SECONDARY Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ) |
32.5; 42.5; 45; 30 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03839082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.