Data monitoring
obesity, ideation, injuries or cardiac health problems)., disordered eating
OBESITY, EVENTS, ADVERSE EVENTS
Dr. Edmond Wickham (Investigator and a board-certified physician in pediatric, internal, and obesity medicine) serves as the internal medical and safety advisor. Dr. Bean (a licensed clinical psychologist) oversees psychological safety (including self-harm, suspected or confirmed child abuse/neglect, or psychopathology) of participants. Any medical or psychological safety concerns that arise are prioritized over intervention participation. As such, intervention and/or assessments are suspended as appropriate until the safety concerns are resolved. Stopping rules for suspending intervention participation are based on identification of serious psychological distress (e.g., clinically significant disordered eating, significant suicidal ideation or self-harm) or child abuse/neglect. A detailed protocol specifies the conditions that must be met before participants can resume participation in the trial if these concerns are identified (e.g., written clearance after an evaluation by a non-study psychologist; Child Protective Service investigation). A similar series of stopping or suspend rules (and associated protocols) addresses medical safety concerns (e.g., injuries or cardiac health problems). Any intervention suspension is reported to the DSMB. If additional mental or physical health concerns emerge during the course of the intervention, Dr. Bean provides appropriate referrals. The study team maintains a current list of providers for referrals, which is continually updated. If desired, the program coordinator can facilitate scheduling an appointment if the participant wishes to see a VCUHS or Children’s Hospital of Richmond provider.An independent DSMB is responsible for monitoring the safety of the data obtained in this study. The DSMB is comprised of a physician, health psychologist, and biostatistician. Formal DSMB meetings occur twice a year, with more frequent meetings on an as-needed basis.A record of adverse events is retained in a study binder for review by the study team, and the independent DSMB. All adverse events are initially evaluated by the PI (Bean) and medical investigator (Wickham). Those events classified as moderate or severe are reported to DSMB Committee Chair for review within 24 hours. The entire DSMB meets to review all serious adverse events, should they occur. In addition, all serious adverse events, both anticipated and unanticipated, are reported to the IRB within 48 hours (and to the NIH within a timeframe consistent with the policy of the institute). Additionally, a summary of all adverse events is submitted to the VCU IRB annually as part of the protocol’s continuing review.