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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis

Intervention / Treatment
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* Other: Usual Care then FitBit
* Other: FitBit then Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care then FitBit<br>This is the waitlist control arm. | Other: Usual Care then FitBit<br>* Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).<br>Other: FitBit then Usual Care<br>* Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.<br>|
| Experimental: FitBit then Usual Care<br>Intervention includes education, physical activity, and a nutrition assessment. | Other: Usual Care then FitBit<br>* Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).<br>Other: FitBit then Usual Care<br>* Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile Technology, Weight, Nutrition