Reporting of Unanticipated Problems, Adverse Events or Deviations Participants will be queried at bi-weekly intervention sessions for adverse events (AE). Events will be recorded on AE tracking forms and categorized based on severity (mild/moderate/severe), seriousness (yes/no), and relatedness to the study intervention (unrelated, possibly, probably, and definitely). Any unanticipated problems, including serious and unexpected adverse events, as well as deviations or protocol changes will be promptly reported by the principal investigator or project manager to the IRB, the WFUSM OAIC DSMB, and Medifast.