An interventional study of Usual Care then FitBit and FitBit then Usual Care in Non-Alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 75 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is the waitlist control arm.
Other: Usual Care then FitBit · Other: FitBit then Usual Care
Intervention includes education, physical activity, and a nutrition assessment.
Other: Usual Care then FitBit · Other: FitBit then Usual Care
Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.
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,
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
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
| Milestone | FitBit Then Usual Care | Usual Care Then FitBit |
|---|---|---|
| Started | 33 | 37 |
| Completed | 7 | 12 |
| Not completed | 26 | 25 |
| Milestone | FitBit Then Usual Care | Usual Care Then FitBit |
|---|---|---|
| Started | 7 | 12 |
| Completed | 0 | 0 |
| Not completed | 7 | 12 |
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.
| percent change | FitBit | Usual Care |
|---|---|---|
| Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score | -13.0 | 8.7 (-3.3 to 16.2) |
Percent change in body weight is measured by (body weight at 6 months minus body weight at baseline) divided by body weight at baseline
| percent change in weight | FitBit | Usual Care |
|---|---|---|
| Percent Change in Body Weight | NA | — |
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.
| score on a scale | FitBit | Usual Care |
|---|---|---|
| Baseline | 32.5 (20 to 60) | 42.5 (30 to 60) |
| 6 months | 45 (30 to 60) | 30 (10 to 50) |
Collected over While in study - up to 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FitBit | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Usual Care | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Age, Continuous(years) | FitBit Then Usual Care | Usual Care Then FitBit | Total |
|---|---|---|---|
| Median | 57 (44 to 65) | 50 (41 to 61) | 52.5 (43 to 63) |
| Sex: Female, Male(Participants) | FitBit Then Usual Care | Usual Care Then FitBit | Total |
|---|---|---|---|
| Female | 21 | 16 | 37 |
| Male | 12 | 21 | 33 |
| Ethnicity (NIH/OMB)(Participants) | FitBit Then Usual Care | Usual Care Then FitBit | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 5 | 6 |
| Not Hispanic or Latino | 32 | 29 | 61 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Race/Ethnicity, Customized(Participants) | FitBit Then Usual Care | Usual Care Then FitBit | Total |
|---|---|---|---|
| Asian | 1 | 3 | 4 |
| African-American | 2 | 1 | 3 |
| White | 28 | 30 | 58 |
| Other | 2 | 3 | 5 |
| Region of Enrollment(participants) | FitBit Then Usual Care | Usual Care Then FitBit | Total |
|---|---|---|---|
| United States | 33 | 37 | 70 |
| Weight(pounds) | FitBit Then Usual Care | Usual Care Then FitBit | Total |
|---|---|---|---|
| Mean | 204.78 ± 58.62 | 204.40 ± 57.54 | 204.49 ± 57.95 |
| Body Mass Index(kg/m^2) | FitBit Then Usual Care | Usual Care Then FitBit | Total |
|---|---|---|---|
| Median | 32.4 (28.2 to 38.6) | 32.02 (28.1 to 36.5) | 32.2 (28.2 to 37.1) |
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