Key result
Remote data collection during the COVID-19 pandemic achieved an 86.9% retention rate at 14 months, which was comparable to the 87.9% retention rate of previous in-person cohorts.
Why the study?
The COVID-19 pandemic significantly altered the research landscape for clinical trials, requiring consideration of how to handle the risks and benefits of continuing them.
Does a Mediterranean Diet, with or without weight loss, improve cognitive functioning in older obese African American adults?
Does a Mediterranean Diet, with or without weight loss, improve cognitive functioning in older obese African American adults?
Absolute Event Rate: 86.9% vs 87.9%
p-value: p=0.84
Adapting a clinical trial to remote data collection during the COVID-19 pandemic yielded high retention rates comparable to in-person visits, demonstrating the feasibility of remote assessments in older, vulnerable populations.
Remote assessments maintain high retention in older adults; extends RCT methodology for remote adaptations in vulnerable populations.
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
No takes yet. Share an insight, caveat, or question.
Fitzgibbon et al. (2021) studied Obesity and cognitive functioning (n=185). Remote data collection (telephone and mail) vs. In-person, face-to-face data collection was evaluated on Any data collected at 14-month follow-up (p=0.84). Remote data collection during the COVID-19 pandemic achieved an 86.9% retention rate at 14 months, which was comparable to the 87.9% retention rate of previous in-person cohorts.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: