Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
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 |
---|---|---|
|
N/A |
Study Design
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
- 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
- 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
- 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
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.- HUM00153750
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
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
|
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
|
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
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 |
mtincopa@mednet.ucla.edu |
- HUM00153750