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

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ClinicalTrials.gov Identifier: NCT03839082
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
American Association for the Study of Liver Diseases
Information provided by (Responsible Party):
Monica A T Konerman, 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.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Other: Usual Care then FitBit Other: FitBit then Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020


Arm Intervention/treatment
Active Comparator: Usual Care then FitBit
This is the waitlist control arm.
Other: Usual Care then FitBit
Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).

Other: FitBit then Usual Care
Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.

Experimental: FitBit then Usual Care
Intervention includes education, physical activity, and a nutrition assessment.
Other: Usual Care then FitBit
Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).

Other: FitBit then Usual Care
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 Measures :
  1. Change in hepatic steatosis as measured controlled attenuation parameter (CAP) score [ Time Frame: Baseline, 6 months, 12 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.


Secondary Outcome Measures :
  1. Percent change in body weight [ Time Frame: Baseline, 6 months ]
  2. Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ) [ Time Frame: Baseline, 6 months ]
    The IPAQ is a validated questionnaire that obtains information on days and minutes per week of different types of physical activity.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839082


Contacts
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Contact: Haila Asefa 734-232-0284 asefah@umich.edu

Locations
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United States, Michigan
The University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Haila Asefa    734-232-0284    asefah@umich.edu   
Principal Investigator: Monica Konerman, MD         
Sponsors and Collaborators
University of Michigan
American Association for the Study of Liver Diseases
Investigators
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Principal Investigator: Monica Konerman University of Michigan

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Responsible Party: Monica A T Konerman, Clinical Lecturer in Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03839082     History of Changes
Other Study ID Numbers: HUM00153750
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Monica A T Konerman, University of Michigan:
Mobile Technology
Weight
Nutrition

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases