Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
Conditions
Keywords
Mobile Technology, Weight, Nutrition
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.
Interventions
OTHERUsual Care then FitBit
Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
OTHERFitBit 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.
Sponsors
American Association for the Study of Liver Diseases
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Five people withdrew prior to receiving fitbits or first surveys.
Participants by arm
| Arm | Count |
|---|---|
| FitBit Then Usual Care 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). | 33 |
| Usual Care Then FitBit 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. | 37 |
| Total | 70 |
Baseline characteristics
| Characteristic | FitBit Then Usual Care | Usual Care Then FitBit | Total |
|---|---|---|---|
| Age, Continuous | 57 years | 50 years | 52.5 years |
| Body Mass Index | 32.4 kg/m^2 | 32.02 kg/m^2 | 32.2 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 29 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized African-American | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 28 Participants | 30 Participants | 58 Participants |
| Region of Enrollment United States | 33 participants | 37 participants | 70 participants |
| Sex: Female, Male Female | 21 Participants | 16 Participants | 37 Participants |
| Sex: Female, Male Male | 12 Participants | 21 Participants | 33 Participants |
| Weight | 204.78 pounds STANDARD_DEVIATION 58.62 | 204.40 pounds STANDARD_DEVIATION 57.54 | 204.49 pounds STANDARD_DEVIATION 57.95 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 44 |
| other Total, other adverse events | 0 / 45 | 0 / 44 |
| serious Total, serious adverse events | 0 / 45 | 0 / 44 |
Outcome results
Primary
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.
Time frame: Baseline, 6 months,
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| FitBit | Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score | -13.0 percent change |
| Usual Care | Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score | 8.7 percent change |
Secondary
Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)
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
Population: Due to COVID 19's impact on participation, data for all participants is not available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FitBit | Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ) | Baseline | 32.5 score on a scale |
| FitBit | Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ) | 6 months | 45 score on a scale |
| Usual Care | Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ) | Baseline | 42.5 score on a scale |
| Usual Care | Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ) | 6 months | 30 score on a scale |
Secondary
Percent Change in Body Weight
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
Population: Weight data is only available for one individual at both times.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FitBit | Percent Change in Body Weight | NA percent change in weight |