Table 2.
Schedule of study measures.
| 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).