Table 2.
Assessment | Baseline In-person |
Every week In-person or phone |
Every month In-person |
End-of-program In-person |
12-week follow-up Phone |
---|---|---|---|---|---|
Primary outcome | |||||
PAI-1 | X | X | |||
Secondary outcomes | |||||
Blood pressure and heart rate | X | X | X | ||
BMI and weight | X | X | X | X | |
Body composition | X | X | X | ||
Cardiopulmonary fitness | X | X | |||
Cholesterol | X | X | |||
Dietary composition | X | X | X | X | |
Glycemic controla | X | X | |||
HRQOL | X | X | X | ||
Inflammationb | X | X | |||
Liver enzymes | X | X | |||
Liver histologyc | X | X (optional) | |||
Markers of hemostasisd | X | X | |||
MRI-PDFF/liver volume | X | X | |||
Microbiome | X | X | |||
NASH biomarkerse | X | X | |||
NASH Clinical Decision Aidsf | X | X | |||
PNPLA3 genotype | X | ||||
PNPLA3 expression | X | X | |||
Covariates | |||||
Activity level | X | X | X | X | X |
Medical/surgical/social history | X | X | X | ||
NASH and other medications | X | X | X | ||
Sociodemographics | X | ||||
Sleep quality | X | X | X | X |
BMI = body mass index; HRQOL = health-related quality of life; MRI-PDFF = magnetic resonance imaging proton density fat fractionation; PNPLA3 = Patatin like phospholipase-3.
Hemoglobin A1c, Insulin level, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Ferritin and White blood cell count.
NASH Activity Score and Fibrosis assessment.
Antithrombin, Factor VII, ADAMTS-13, D-dimer, Factor VIII, Fibrinogen, International Normalized Ratio (INR), P-selection, Platelet count, Protein S, Protein C, Thromboelastography (TEG), von Willebrand Factor.
Adiponectin, Cytokeratin (CK)-18.
NAFLD Fibrosis Score, Fibrosis-4 Index (FIB-4).