CONSERVE (CONSORT and SPIRIT Extension for Randomized Clinical Trials Revised in Extenuating Circumstances) Detailing the Alterations Made to Intervention and Assessments Based on COVID-19
Questionnaires were all conducted online. In-person weight and laboratory assessments were delayed until June 2020 when approval from the university was granted. The following adjustments were made to laboratory procedures to ensure social distancing and safety of participants:Appointment times were lengthened to avoid overlap between participants.For cohort 1, 24-mo weight, blood pressure, and blood samples were collected.No dual-energy x-ray absorptiometry scans or body circumference measures were taken to reduce appointment time and close contact.For cohort 2, 12-mo weight, blood pressure, blood samples, and dual-energy x-ray absorptiometry were collected.For participants who did not want to return to in-person assessments, staff provided an option for participants to have their weight assessed outside or to provide a self-reported weight.We continued the nutrition intervention components until assessments could be completed.