Table 1.
Time (activity or assessment) | Pre-enrollment (screening and consent visit) | Baseline (preintervention assessment and randomization to intervention arm) | Weeks 0-12 (intervention period) | Week 12 (postintervention assessment) | Weeks 12-24 (maintenance period) | Week 24 (postmaintenance assessment) |
Informed consent | ✓ | — | — | — | — | — |
Health history | ✓ | — | — | — | — | — |
Demographics and background information | ✓ | — | — | — | — | — |
Inclusion or exclusion criteria assessment | ✓ | — | — | — | — | — |
Craving EMAa | ✓ | — | ✓ | ✓ | ✓ | ✓ |
Laboratory-based chemistry testing | ✓ | ✓ | — | ✓ | — | ✓ |
Online self-report measures | — | ✓ | — | ✓ | — | ✓ |
24-hour dietary recall | — | ✓ | — | ✓ | — | ✓ |
Computerized cognitive assessment | ✓ | — | — | ✓ | — | ✓ |
Anthropometricsb | ✓ | — | — | ✓ | — | ✓ |
Weekly diet and/or mindful eating classes | — | — | ✓ | — | — | — |
Monthly diet and/or mindful eating follow-up classes | — | — | — | — | ✓ | — |
Ketone testing for dietary adherencec | — | — | ✓ | ✓ | ✓ | ✓ |
Home glucose testing for safetyd | — | — | ✓ | — | ✓ | — |
aEMA: ecological momentary assessment, administered over 1 week at each pre-enrollment, baseline, and weeks 7, 13, 19, and 24.
bHeight at baseline only.
cKetone testing 3 times per week during intervention period and 2 times per week during maintenance period.
dOnly for individuals using insulin and sulfonylurea medications.