Back to resultsStructured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care then FitBit
FitBit then Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Mobile Technology, Weight, Nutrition
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
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care then FitBit
FitBit then Usual Care
Arm Description
This is the waitlist control arm.
Intervention includes education, physical activity, and a nutrition assessment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT03839082
First Posted
February 11, 2019
Last Updated
April 5, 2022
Sponsor
University of Michigan
Collaborators
American Association for the Study of Liver Diseases
1. Study Identification
Unique Protocol Identification Number
NCT03839082
Brief Title
Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
February 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
American Association for the Study of Liver Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Keywords
Mobile Technology, Weight, Nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care then FitBit
Arm Type
Active Comparator
Arm Description
This is the waitlist control arm.
Arm Title
FitBit then Usual Care
Arm Type
Experimental
Arm Description
Intervention includes education, physical activity, and a nutrition assessment.
Intervention Type
Other
Intervention Name(s)
Usual Care then FitBit
Intervention Description
Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
Intervention Type
Other
Intervention Name(s)
FitBit then Usual Care
Intervention Description
Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.
Primary Outcome Measure Information:
Title
Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score
Description
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.
Time Frame
Baseline, 6 months,
Secondary Outcome Measure Information:
Title
Percent Change in Body Weight
Description
Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline
Time Frame
Baseline, 6 months
Title
Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)
Description
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.
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Konerman
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
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