Adapting to the impact of the COVID-19 pandemic on a randomized controlled trial examining lifestyle behaviors on cognitive functioning in obese African American adults: Building Research in Diet and Cognition (BRIDGE)

Marian Fitzgibbon, Lara Blumstein, Linda Schiffer, Mirjana A Antonic, Andrew McLeod, Roxanne Dakers, Leo Restrepo, Elizabeth A Boots, Jennifer C Sanchez-Flack, Lisa Tussing-Humphreys, Melissa Lamar, Marian Fitzgibbon, Lara Blumstein, Linda Schiffer, Mirjana A Antonic, Andrew McLeod, Roxanne Dakers, Leo Restrepo, Elizabeth A Boots, Jennifer C Sanchez-Flack, Lisa Tussing-Humphreys, Melissa Lamar

Abstract

Background . The COVID-19 pandemic has significantly 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. For the Cohort 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 Cohort 3 and earlier cohorts: data were collected for 86.9% of cohort 3 (remote) and 87.9% of cohorts 1 and2 (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. ClinicalTrials.gov NCT03129048.

Conflict of interest statement

Competing interests: The authors declare that they have no competing interests.

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Source: PubMed

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