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

Not Applicable

Completed

• Conditions: Non-alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease
• Interventions: Other: Usual Care then FitBit; Other: FitBit then Usual Care

• Registration Number: NCT03839082
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Start: 2019-03-20
• Primary Completion: 2021-02-26
• Study Completion: 2021-02-26
• Results First Submitted: 2022-02-25
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Results First Posted: 2022-05-03
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual Care then FitBit	Usual Care then FitBit	This is the waitlist control arm.
Usual Care then FitBit	FitBit then Usual Care	This is the waitlist control arm.
FitBit then Usual Care	FitBit then Usual Care	Intervention includes education, physical activity, and a nutrition assessment.
FitBit then Usual Care	Usual Care then FitBit	Intervention includes education, physical activity, and a nutrition assessment.

Primary Outcome Measures

Name	Time	Method
Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score	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 Outcome Measures

Name	Time	Method
Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)	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.
Percent Change in Body Weight	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

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States