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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03839082
Collaborator
American Association for the Study of Liver Diseases (Other)
75
1
2
23.3
3.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Usual Care then FitBit
  • Other: FitBit then Usual Care
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Crossover 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
Actual Study Start Date :
Mar 20, 2019
Actual Primary Completion Date :
Feb 26, 2021
Actual Study Completion Date :
Feb 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score [Baseline, 6 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 (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

  1. Percent Change in Body Weight [Baseline, 6 months]

    Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline

  2. Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ) [Baseline, 6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan
  • American Association for the Study of Liver Diseases

Investigators

  • Principal Investigator: Monica Konerman, University of Michigan

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Monica Tincopa, Clinical Lecturer in Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier:
NCT03839082
Other Study ID Numbers:
  • HUM00153750
First Posted:
Feb 15, 2019
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Monica Tincopa, Clinical Lecturer in Internal Medicine, University of Michigan
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Five people withdrew prior to receiving fitbits or first surveys.
Arm/Group Title FitBit Then Usual Care Usual Care Then FitBit
Arm/Group Description Intervention includes education, physical activity, and a nutrition assessment. 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). 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. This is the waitlist control arm. 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). Once they start FitBit,, Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.
Period Title: Initial Randomization
STARTED 33 37
COMPLETED 7 12
NOT COMPLETED 26 25
Period Title: Initial Randomization
STARTED 7 12
COMPLETED 0 0
NOT COMPLETED 7 12

Baseline Characteristics

Arm/Group Title FitBit Then Usual Care Usual Care Then FitBit Total
Arm/Group Description Intervention includes education, physical activity, and a nutrition assessment. 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. 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). This is the waitlist control arm. 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). Once they start FitBit, intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done. Total of all reporting groups
Overall Participants 33 37 70
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
57
50
52.5
Sex: Female, Male (Count of Participants)
Female
21
63.6%
16
43.2%
37
52.9%
Male
12
36.4%
21
56.8%
33
47.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
3%
5
13.5%
6
8.6%
Not Hispanic or Latino
32
97%
29
78.4%
61
87.1%
Unknown or Not Reported
0
0%
3
8.1%
3
4.3%
Race/Ethnicity, Customized (Count of Participants)
Asian
1
3%
3
8.1%
4
5.7%
African-American
2
6.1%
1
2.7%
3
4.3%
White
28
84.8%
30
81.1%
58
82.9%
Other
2
6.1%
3
8.1%
5
7.1%
Region of Enrollment (participants) [Number]
United States
33
100%
37
100%
70
100%
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]
204.78
(58.62)
204.40
(57.54)
204.49
(57.95)
Body Mass Index (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]
32.4
32.02
32.2

Outcome Measures

1. Primary Outcome
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,

Outcome Measure Data

Analysis Population Description
Due to the disruption caused by the COVID epidemic, follow up was dramatically lower than planned, and values were missing for some individuals in both arms.
Arm/Group Title FitBit Usual Care
Arm/Group Description Intervention includes education, physical activity, and a nutrition assessment. FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done. This is the waitlist control arm. Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
Measure Participants 1 5
Median (Inter-Quartile Range) [percent change]
-13.0
8.7
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Weight data is only available for one individual at both times.
Arm/Group Title FitBit Usual Care
Arm/Group Description Intervention includes education, physical activity, and a nutrition assessment. FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done. This is the waitlist control arm. Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
Measure Participants 1 0
Number [percent change in weight]
NA
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Due to COVID 19's impact on participation, data for all participants is not available.
Arm/Group Title FitBit Usual Care
Arm/Group Description Intervention includes education, physical activity, and a nutrition assessment. FitBit: Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done. This is the waitlist control arm. Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
Measure Participants 10 14
Baseline
32.5
42.5
6 months
45
30

Adverse Events

Time Frame While in study - up to 1 year
Adverse Event Reporting Description
Arm/Group Title FitBit Usual Care
Arm/Group Description Intervention includes education, physical activity, and a nutrition assessment. FitBit: 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: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
All Cause Mortality
FitBit Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/45 (0%) 0/44 (0%)
Serious Adverse Events
FitBit Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/45 (0%) 0/44 (0%)
Other (Not Including Serious) Adverse Events
FitBit Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/45 (0%) 0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Monica Tincopa
Organization University of California Los Angeles
Phone 310 825-2631
Email mtincopa@mednet.ucla.edu
Responsible Party:
Monica Tincopa, Clinical Lecturer in Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier:
NCT03839082
Other Study ID Numbers:
  • HUM00153750
First Posted:
Feb 15, 2019
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022