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| Name | Class |
|---|---|
| American Association for the Study of Liver Diseases | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care then FitBit | Active Comparator | This is the waitlist control arm. |
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| FitBit then Usual Care | Experimental | Intervention includes education, physical activity, and a nutrition assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care then FitBit | Other | Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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, |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 6 months |
| Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica Konerman | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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Five people withdrew prior to receiving fitbits or first surveys.
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| ID | Title | Description |
|---|---|---|
| FG000 | FitBit Then Usual Care | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Randomization |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2019 |
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| FitBit then Usual Care | Other | Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done. |
|
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. |
| Baseline, 6 months |
| FG001 | 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. |
| COMPLETED | completing visit 2 |
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| NOT COMPLETED |
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| Crossover to Other Arm |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | pounds |
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| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Inter-Quartile Range | percent change | Baseline, 6 months, |
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| 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 | Weight data is only available for one individual at both times. | Posted | Number | percent change in weight | Baseline, 6 months |
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| 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. | Due to COVID 19's impact on participation, data for all participants is not available. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6 months |
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While in study - up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FitBit | 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. | 0 | 45 | 0 | 45 | 0 | 45 |
| EG001 | Usual Care | Usual Care: Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device). | 0 | 44 | 0 | 44 | 0 | 44 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monica Tincopa | University of California Los Angeles | 310 825-2631 | mtincopa@mednet.ucla.edu |
| Feb 25, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| African-American |
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| White |
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| Other |
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| Participants |
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