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

NCT ID: NCT03839082

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2021-02-26

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care then FitBit

This is the waitlist control arm.

Group Type: ACTIVE_COMPARATOR

FitBit then Usual Care

Intervention Type: OTHER

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

Usual Care then FitBit

Intervention Type: OTHER

Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).

FitBit then Usual Care

Intervention includes education, physical activity, and a nutrition assessment.

Group Type: EXPERIMENTAL

FitBit then Usual Care

Intervention Type: OTHER

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

Usual Care then FitBit

Intervention Type: OTHER

Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Association for the Study of Liver Diseases

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Monica Tincopa

Clinical Lecturer in Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Konerman

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

The University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00153750

Identifier Type: -

Identifier Source: org_study_id