Adapting to the COVID-19 pandemic on Building Research in Diet and Cognition (BRIDGE) trial

Abstract

Abstract Background The COVID-19 pandemic has altered the research landscape for clinical trials, requiring thoughtful consideration regarding how to handle the risks and benefits of continuing them. Design This brief report describes the experience of adapting the Building Research in Diet and Cognition (BRIDGE) study, a randomized clinical trial examining the effects of the Mediterranean diet, with and without weight loss, on cognitive functioning in 185 older obese African American adults during the COVID-19 pandemic. Measurement The University of Illinois at Chicago (UIC) developed an expedited amendment process for research shifting to remote data collection. We conducted the study in three consecutive groups. For group 3, 14-month data collection period, we adapted our protocol to allow data collection via telephone and e-mail. We were unable to collect certain measures that required face-to-face contact. Results For measures that could be collected remotely, 14-month retention was similar for group 3 compared to groups 1 and 2: data were collected for 86.9% of group 3 (remote) and 87.9% of groups 1 and 2 (face to face), p = .84. Conclusions In order to preserve the integrity of our clinical trial and ensure the safety of our participants and staff during the COVID-19 pandemic, we had to carefully and efficiently adapt our data collection procedures. The procedures put in place allowed us to collect our primary outcomes and the majority of our secondary outcomes and will enable us to examine the role of dietary intake, with and without weight loss, on cognitive functioning in a vulnerable and high-risk population. Trial registration ClinicalTrials.gov NCT3129048. Registration Date: 4/17/2017.