Full text

Turn on search term navigation

© The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

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.

Details

Title
Adapting to the COVID-19 pandemic on Building Research in Diet and Cognition (BRIDGE) trial
Author
Fitzgibbon, Marian 1 ; Blumstein, Lara 2 ; Schiffer, Linda 2 ; Antonic, Mirjana A. 2 ; McLeod, Andrew 3 ; Dakers, Roxanne 2 ; Restrepo, Leo 2 ; Boots, Elizabeth A. 2 ; Sanchez-Flack, Jennifer C. 4 ; Tussing-Humphreys, Lisa 5 ; Lamar, Melissa 6 

 University of Illinois at Chicago, Institute for Health Research and Policy, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319); University of Illinois at Chicago, Department of Pediatrics, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319); University of Illinois at Chicago, School of Public Health, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319); University of Illinois at Chicago, University of Illinois Cancer Center, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319) 
 University of Illinois at Chicago, Institute for Health Research and Policy, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319) 
 University of Illinois at Chicago, Institute for Health Research and Policy, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319); University of Illinois at Chicago, Department of Kinesiology and Nutrition, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319) 
 University of Illinois at Chicago, Institute for Health Research and Policy, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319); University of Illinois at Chicago, Department of Pediatrics, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319); University of Illinois at Chicago, University of Illinois Cancer Center, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319) 
 University of Illinois at Chicago, Institute for Health Research and Policy, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319); University of Illinois at Chicago, University of Illinois Cancer Center, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319); University of Illinois at Chicago, Department of Kinesiology and Nutrition, Chicago, USA (GRID:grid.185648.6) (ISNI:0000 0001 2175 0319) 
 Rush University, Rush Alzheimer’s Disease Center, Chicago, USA (GRID:grid.262743.6) (ISNI:0000000107058297) 
Pages
459
Publication year
2021
Publication date
Dec 2021
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2730342001
Copyright
© The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.