At a glance

ClinicalIndex Comparison Record

N/ACompleted· 75 enrolled

Drug / intervention

Usual Care then FitBit +1 moreother

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03839082

NCT03839082N/ACompleted

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

University of Michigan·interventional·Posted Feb 15, 2019·Updated May 3, 2022

In Brief

A clinical study evaluating Usual Care then FitBit and FitBit then Usual Care for Non-Alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsNon-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis

CountriesUnited States

CollaboratorsAmerican Association for the Study of Liver Diseases

Timeline

N/ACompletedFinished

20192020202120222023202420252026

First PostedFeb 2019

Enrollment StartMar 2019

Primary CompletionFeb 2021

TodayJul 2026

First PostedFeb 15, 2019

Enrollment StartMar 20, 2019

Primary CompletionFeb 26, 2021

TodayJul 2, 2026

Enrollment to primary: 1.9 yearsPosted 7.4 years ago

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.