Marian Fitzgibbon1,2,3,4, Lara Blumstein5, Linda Schiffer5, Mirjana A Antonic5, Andrew McLeod5,6, Roxanne Dakers5, Leo Restrepo5, Elizabeth A Boots5, Jennifer C Sanchez-Flack5,7,8, Lisa Tussing-Humphreys5,8,6, Melissa Lamar9. 1. Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL, 60608, USA. mlf@uic.edu. 2. Department of Pediatrics, University of Illinois at Chicago, 1200 West Harrison Street, Chicago, IL, 60607, USA. mlf@uic.edu. 3. School of Public Health, University of Illinois at Chicago, 1603 W Taylor St, Chicago, IL, 60612, USA. mlf@uic.edu. 4. University of Illinois Cancer Center, University of Illinois at Chicago, 818 South Wolcott Avenue, Chicago, IL, 60612, USA. mlf@uic.edu. 5. Institute for Health Research and Policy, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL, 60608, USA. 6. Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 W. Taylor St, Chicago, IL, 60612, USA. 7. Department of Pediatrics, University of Illinois at Chicago, 1200 West Harrison Street, Chicago, IL, 60607, USA. 8. University of Illinois Cancer Center, University of Illinois at Chicago, 818 South Wolcott Avenue, Chicago, IL, 60612, USA. 9. Rush Alzheimer's Disease Center, Rush University, 1750 West Harrison Street, Chicago, IL, 60612, USA.
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.
RCT Entities:
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.
Authors: Robert S Wilson; Sue E Leurgans; Tatiana M Foroud; Robert A Sweet; Neill Graff-Radford; Richard Mayeux; David A Bennett Journal: Arch Neurol Date: 2010-07
Authors: Lisa Tussing-Humphreys; Melissa Lamar; James A Blumenthal; Michael Babyak; Giamila Fantuzzi; Lara Blumstein; Linda Schiffer; Marian L Fitzgibbon Journal: Contemp Clin Trials Date: 2017-06-07 Impact factor: 2.226
Authors: W C Willett; L Sampson; M J Stampfer; B Rosner; C Bain; J Witschi; C H Hennekens; F E Speizer Journal: Am J Epidemiol Date: 1985-07 Impact factor: 4.897
Authors: Vladimir Hachinski; Costantino Iadecola; Ron C Petersen; Monique M Breteler; David L Nyenhuis; Sandra E Black; William J Powers; Charles DeCarli; Jose G Merino; Raj N Kalaria; Harry V Vinters; David M Holtzman; Gary A Rosenberg; Anders Wallin; Martin Dichgans; John R Marler; Gabrielle G Leblanc Journal: Stroke Date: 2006-08-17 Impact factor: 7.914