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

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 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.

Trial registration: ClinicalTrials.gov NCT03129048.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

References

    1. McDermott MM, Newman AB. Preserving clinical trial integrity during the coronavirus pandemic. JAMA. 2020;323(21):2135–2136. doi: 10.1001/jama.2020.4689.
    1. Coleman BC, Kean J, Brandt CA, Peduzzi P, Kerns RD. Adapting to disruption of research during the COVID-19 pandemic while testing nonpharmacological approaches to pain management. Transl Behav Med. 2020;10(4):827–834. doi: 10.1093/tbm/ibaa074.
    1. Trends, Charts, and Maps. (2021). . Accessed on January 22, 2021. Retrieved from .
    1. WHO coronavirus disease (COVID-19) dashboard. (2020). Geneva: World Health Organization. Accessed on January 19, 2021. Retrieved from .
    1. Tussing-Humphreys L, Lamar M, Blumenthal JA, Babyak M, Fantuzzi G, Blumstein L, Schiffer L, Fitzgibbon ML. Building research in diet and cognition: the BRIDGE randomized controlled trial. Contemp Clin Trials. 2017;59:87–97. doi: 10.1016/j.cct.2017.06.003.
    1. Sanchez-Flack JC, Tussing-Humphreys L, Lamar M, Fantuzzi G, Schiffer L, Blumstein L, et al. Building Research in Diet and Cognition (BRIDGE): baseline characteristics of older obese African American adults in a randomized controlled trial to examine the effect of the Mediterranean Diet with and without weight loss on cognitive functioning. Prev Med Rep. 2020;22:101302. 10.1016/j.pmedr.2020.101302.
    1. COVID-19. Center for Disease Control and Prevention. Accessed on January 12, 2021. Retrieved from
    1. Coronavirus Disease 2019 (COVID-19): Information for NIH applicants and recipients of NIH funding. National Institutes of Health. Accessed on January 12, 2021. Retrieved from .
    1. Hachinski V, Iadecola C, Petersen RC, Breteler MM, Nyenhuis DL, Black SE, et al. National Institute of Neurological Disorders and Stroke–Canadian stroke network vascular cognitive impairment harmonization standards. Stroke. 2006;37(9):2220–2241. doi: 10.1161/01.STR.0000237236.88823.47.
    1. Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, et al. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol. 1985;122(1):51–65. doi: 10.1093/oxfordjournals.aje.a114086.
    1. Santos-Lozano A, Marín PJ, Torres-Luque G, Ruiz JR, Lucía A, Garatachea N. Technical variability of the GT3X accelerometer. Med Eng Phys. 2012;34(6):787–790. doi: 10.1016/j.medengphy.2012.02.005.
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166(1):111–7. 10.1164/ajrccm.166.1.at1102.
    1. Wilson RS, Leurgans SE, Foroud TM, Sweet RA, Graff-Radford N, Mayeux R, Bennett DA. Telephone assessment of cognitive function in the late-onset Alzheimer’s disease family study. Arch Neurol. 2010;67(7):855–861. doi: 10.1001/archneurol.2010.129.
    1. Ricker JH, Axelrod BN. Analysis of an oral paradigm for the Trail Making Test. Assessment. 1994;1(1):47–51. doi: 10.1177/1073191194001001007.
    1. Kaemmerer T, Riordan P. Oral adaptation of the trail making test: a practical review. Appl Neuropsychol Adult. 2016;23(5):384–389. doi: 10.1080/23279095.2016.1178645.
    1. Wechsler D. Wechsler Memory Scale (3rd ed.) San Antonio, TX: Psychological Corporation; 1997.
    1. Stroop JR. Studies of interference in serial verbal reactions. J Exp Psychol. 1935;18(6):643–662. doi: 10.1037/h0054651.
    1. Singh JA, Bandewar SV, Bukusi EA. The impact of the COVID-19 pandemic response on other health research. Bull World Health Organ. 2020;98(9):625–631. doi: 10.2471/BLT.20.257485.
    1. Alcendor DJ. Racial disparities-associated COVID-19 mortality among minority populations in the US. J Clin Med. 2020;9(8):2442. doi: 10.3390/jcm9082442.
    1. Reyes C, Husain N, Gutowski C, St Clair, S., & Pratt, G. Chicago’s coronavirus disparity: Black Chicagoans are dying at nearly six times the rate of white residents, data show. Chicago Tribune. 2020, 7.
    1. Shadlen MF, Siscovick D, Fitzpatrick AL, Dulberg C, Kuller LH, Jackson S. Education, cognitive test scores, and black-white differences in dementia risk. J Am Geriatr Soc. 2006;54(6):898–905. doi: 10.1111/j.1532-5415.2006.00747.x.
    1. Mehta KM, Simonsick EM, Rooks R, Newman AB, Pope SK, Rubin SM, et al. Black and white differences in cognitive function test scores: what explains the difference? J Am Geriatr Soc. 2004;52(12):2120–2127. doi: 10.1111/j.1532-5415.2004.52575.x.
    1. Rovner BW, Casten RJ, Harris LF. Cultural diversity and views on Alzheimer’s disease in older African Americans. Alzheimer Dis Assoc Disord. 2013;27(2):133–137. doi: 10.1097/WAD.0b013e3182654794.
    1. Lourida I, Soni M, Thompson-Coon J, Purandare N, Lang IA, Ukoumunne OC, Llewellyn DJ. Mediterranean diet, cognitive function, and dementia: a systematic review. Epidemiology. 2013;24(4):479–489. doi: 10.1097/EDE.0b013e3182944410.
    1. Valls-Pedret C, Ros E. Commentary: Mediterranean diet and cognitive outcomesEpidemiological Evidence Suggestive, Randomized Trials Needed. Epidemiology. 2013;24(4):503–506. doi: 10.1097/EDE.0b013e318296bf8e.
    1. Rolland Y, van Kan GA, Vellas B. Healthy brain aging: role of exercise and physical activity. Clin Geriatr Med. 2010;26(1):75–87. doi: 10.1016/j.cger.2009.11.002.

Source: PubMed

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