NCT03839082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 3, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

February 11, 2019

Results QC Date

February 25, 2022

Last Update Submit

April 5, 2022

Conditions

Non-Alcoholic Fatty Liver DiseaseNon-alcoholic Steatohepatitis

Keywords

Mobile TechnologyWeightNutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Percent Change in Body Weight

    Baseline, 6 months

  • Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)

    Baseline, 6 months

Study Arms (2)

Usual Care then FitBit

ACTIVE COMPARATOR

This is the waitlist control arm.

Other: Usual Care then FitBitOther: FitBit then Usual Care

FitBit then Usual Care

EXPERIMENTAL

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

Other: Usual Care then FitBitOther: FitBit then Usual Care

Interventions

Usual Care then FitBitOTHER

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

FitBit then Usual CareUsual Care then FitBit
FitBit then Usual CareOTHER

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

FitBit then Usual CareUsual Care then FitBit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseBody Weight

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Monica Tincopa
Organization
University of California Los Angeles
mtincopa@mednet.ucla.edu
310 825-2631

Study Officials

  • Monica Konerman

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer in Internal Medicine

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

March 20, 2019

Primary Completion

February 26, 2021

Study Completion

February 26, 2021

Last Updated

May 3, 2022

Results First Posted

May 3, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)