Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design
Horwitz, Leora I; Thaweethai, Tanayott; Brosnahan, Shari B; Cicek, Mine S; Fitzgerald, Megan L; Goldman, Jason D; Hess, Rachel; Hodder, S L; Jacoby, Vanessa L; Jordan, Michael R; Krishnan, Jerry A; Laiyemo, Adeyinka O; Metz, Torri D; Nichols, Lauren; Patzer, Rachel E; Sekar, Anisha; Singer, Nora G; Stiles, Lauren E; Taylor, Barbara S; Ahmed, Shifa; Algren, Heather A; Anglin, Khamal; Aponte-Soto, Lisa; Ashktorab, Hassan; Bassett, Ingrid V; Bedi, Brahmchetna; Bhadelia, Nahid; Bime, Christian; Bind, Marie-Abele C; Black, Lora J; Blomkalns, Andra L; Brim, Hassan; Castro, Mario; Chan, James; Charney, Alexander W; Chen, Benjamin K; Chen, Li Qing; Chen, Peter; Chestek, David; Chibnik, Lori B; Chow, Dominic C; Chu, Helen Y; Clifton, Rebecca G; Collins, Shelby; Costantine, Maged M; Cribbs, Sushma K; Deeks, Steven G; Dickinson, John D; Donohue, Sarah E; Durstenfeld, Matthew S; Emery, Ivette F; Erlandson, Kristine M; Facelli, Julio C; Farah-Abraham, Rachael; Finn, Aloke V; Fischer, Melinda S; Flaherman, Valerie J; Fleurimont, Judes; Fonseca, Vivian; Gallagher, Emily J; Gander, Jennifer C; Gennaro, Maria Laura; Gibson, Kelly S; Go, Minjoung; Goodman, Steven N; Granger, Joey P; Greenway, Frank L; Hafner, John W; Han, Jenny E; Harkins, Michelle S; Hauser, Kristine S P; Heath, James R; Hernandez, Carla R; Ho, On; Hoffman, Matthew K; Hoover, Susan E; Horowitz, Carol R; Hsu, Harvey; Hsue, Priscilla Y; Hughes, Brenna L; Jagannathan, Prasanna; James, Judith A; John, Janice; Jolley, Sarah; Judd, S E; Juskowich, Joy J; Kanjilal, Diane G; Karlson, Elizabeth W; Katz, Stuart D; Kelly, J Daniel; Kelly, Sara W; Kim, Arthur Y; Kirwan, John P; Knox, Kenneth S; Kumar, Andre; Lamendola-Essel, Michelle F; Lanca, Margaret; Lee-Lannotti, Joyce K; Lefebvre, R Craig; Levy, Bruce D; Lin, Janet Y; Logarbo, Brian P; Logue, Jennifer K; Longo, Michele T; Luciano, Carlos A; Lutrick, Karen; Malakooti, Shahdi K; Mallett, Gail; Maranga, Gabrielle; Marathe, Jai G; Marconi, Vincent C; Marshall, Gailen D; Martin, Christopher F; Martin, Jeffrey N; May, Heidi T; McComsey, Grace A; McDonald, Dylan; Mendez-Figueroa, Hector; Miele, Lucio; Mittleman, Murray A; Mohandas, Sindhu; Mouchati, Christian; Mullington, Janet M; Nadkarni, Girish N; Nahin, Erica R; Neuman, Robert B; Newman, Lisa T; Nguyen, Amber; Nikolich, Janko Z; Ofotokun, Igho; Ogbogu, Princess U; Palatnik, Anna; Palomares, Kristy T S; Parimon, Tanyalak; Parry, Samuel; Parthasarathy, Sairam; Patterson, Thomas F; Pearman, Ann; Peluso, Michael J; Pemu, Priscilla; Pettker, Christian M; Plunkett, Beth A; Pogreba-Brown, Kristen; Poppas, Athena; Porterfield, J Zachary; Quigley, John G; Quinn, Davin K; Raissy, Hengameh; Rebello, Candida J; Reddy, Uma M; Reece, Rebecca; Reeder, Harrison T; Rischard, Franz P; Rosas, Johana M; Rosen, Clifford J; Rouphael, Nadine G; Rouse, Dwight J; Ruff, Adam M; Saint Jean, Christina; Sandoval, Grecio J; Santana, Jorge L; Schlater, Shannon M; Sciurba, Frank C; Selvaggi, Caitlin; Seshadri, Sudha; Sesso, Howard D; Shah, Dimpy P; Shemesh, Eyal; Sherif, Zaki A; Shinnick, Daniel J; Simhan, Hyagriv N; Singh, Upinder; Sowles, Amber; Subbian, Vignesh; Sun, Jun; Suthar, Mehul S; Teunis, Larissa J; Thorp, John M; Ticotsky, Amberly; Tita, Alan T N; Tragus, Robin; Tuttle, Katherine R; Urdaneta, Alfredo E; Utz, P J; VanWagoner, Timothy M; Vasey, Andrew; Vernon, Suzanne D; Vidal, Crystal; Walker, Tiffany; Ward, Honorine D; Warren, David E; Weeks, Ryan M; Weiner, Steven J; Weyer, Jordan C; Wheeler, Jennifer L; Whiteheart, Sidney W; Wiley, Zanthia; Williams, Natasha J; Wisnivesky, Juan P; Wood, John C; Yee, Lynn M; Young, Natalie M; Zisis, Sokratis N; Foulkes, Andrea S
IMPORTANCE/OBJECTIVE:SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. METHODS:RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. DISCUSSION/CONCLUSIONS:RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options. REGISTRATION/BACKGROUND:NCT05172024.
PMID: 37352211
ISSN: 1932-6203
CID: 5538502
The U.S. COVID-19 County Policy Database: a novel resource to support pandemic-related research
Hamad, Rita; Lyman, Kristin A; Lin, Feng; Modrow, Madelaine F; Ozluk, Pelin; Azar, Kristen M J; Goodin, Amie; Isasi, Carmen R; Kitzman, Heather E; Knight, Sara J; Marcus, Gregory M; McMahill-Walraven, Cheryl N; Meissner, Paul; Nair, Vinit; O'Brien, Emily C; Olgin, Jeffrey E; Peyser, Noah D; Sylwestrzak, Gosia; Williams, Natasha; Pletcher, Mark J; Carton, Thomas
BACKGROUND:It is increasingly recognized that policies have played a role in both alleviating and exacerbating the health and economic consequences of the COVID-19 pandemic. There has been limited systematic evaluation of variation in U.S. local COVID-19-related policies. This study introduces the U.S. COVID-19 County Policy (UCCP) Database, whose objective is to systematically gather, characterize, and assess variation in U.S. county-level COVID-19-related policies. METHODS:In January-March 2021, we collected an initial wave of cross-sectional data from government and media websites for 171 counties in 7 states on 22 county-level COVID-19-related policies within 3 policy domains that are likely to affect health: (1) containment/closure, (2) economic support, and (3) public health. We characterized the presence and comprehensiveness of policies using univariate analyses. We also examined the correlation of policies with one another using bivariate Spearman's correlations. Finally, we examined geographical variation in policies across and within states. RESULTS:There was substantial variation in the presence and comprehensiveness of county policies during January-March 2021. For containment and closure policies, the percent of counties with no restrictions ranged from 0% (for public events) to more than half for public transportation (67.8%), hair salons (52.6%), and religious gatherings (52.0%). For economic policies, 76.6% of counties had housing support, while 64.9% had utility relief. For public health policies, most were comprehensive, with 70.8% of counties having coordinated public information campaigns, and 66.7% requiring masks outside the home at all times. Correlations between containment and closure policies tended to be positive and moderate (i.e., coefficients 0.4-0.59). There was variation within and across states in the number and comprehensiveness of policies. CONCLUSIONS:This study introduces the UCCP Database, presenting granular data on local governments' responses to the COVID-19 pandemic. We documented substantial variation within and across states on a wide range of policies at a single point in time. By making these data publicly available, this study supports future research that can leverage this database to examine how policies contributed to and continue to influence pandemic-related health and socioeconomic outcomes and disparities. The UCCP database is available online and will include additional time points for 2020-2021 and additional counties nationwide.
PMCID:9548418
PMID: 36217102
ISSN: 1471-2458
CID: 5351962
Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial
Popp, Collin J; Hu, Lu; Kharmats, Anna Y; Curran, Margaret; Berube, Lauren; Wang, Chan; Pompeii, Mary Lou; Illiano, Paige; St-Jules, David E; Mottern, Meredith; Li, Huilin; Williams, Natasha; Schoenthaler, Antoinette; Segal, Eran; Godneva, Anastasia; Thomas, Diana; Bergman, Michael; Schmidt, Ann Marie; Sevick, Mary Ann
Importance:Interindividual variability in postprandial glycemic response (PPGR) to the same foods may explain why low glycemic index or load and low-carbohydrate diet interventions have mixed weight loss outcomes. A precision nutrition approach that estimates personalized PPGR to specific foods may be more efficacious for weight loss. Objective:To compare a standardized low-fat vs a personalized diet regarding percentage of weight loss in adults with abnormal glucose metabolism and obesity. Design, Setting, and Participants:The Personal Diet Study was a single-center, population-based, 6-month randomized clinical trial with measurements at baseline (0 months) and 3 and 6 months conducted from February 12, 2018, to October 28, 2021. A total of 269 adults aged 18 to 80 years with a body mass index (calculated as weight in kilograms divided by height in meters squared) ranging from 27 to 50 and a hemoglobin A1c level ranging from 5.7% to 8.0% were recruited. Individuals were excluded if receiving medications other than metformin or with evidence of kidney disease, assessed as an estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration equation, to avoid recruiting patients with advanced type 2 diabetes. Interventions:Participants were randomized to either a low-fat diet (<25% of energy intake; standardized group) or a personalized diet that estimates PPGR to foods using a machine learning algorithm (personalized group). Participants in both groups received a total of 14 behavioral counseling sessions and self-monitored dietary intake. In addition, the participants in the personalized group received color-coded meal scores on estimated PPGR delivered via a mobile app. Main Outcomes and Measures:The primary outcome was the percentage of weight loss from baseline to 6 months. Secondary outcomes included changes in body composition (fat mass, fat-free mass, and percentage of body weight), resting energy expenditure, and adaptive thermogenesis. Data were collected at baseline and 3 and 6 months. Analysis was based on intention to treat using linear mixed modeling. Results:Of a total of 204 adults randomized, 199 (102 in the personalized group vs 97 in the standardized group) contributed data (mean [SD] age, 58 [11] years; 133 women [66.8%]; mean [SD] body mass index, 33.9 [4.8]). Weight change at 6 months was -4.31% (95% CI, -5.37% to -3.24%) for the standardized group and -3.26% (95% CI, -4.25% to -2.26%) for the personalized group, which was not significantly different (difference between groups, 1.05% [95% CI, -0.40% to 2.50%]; P = .16). There were no between-group differences in body composition and adaptive thermogenesis; however, the change in resting energy expenditure was significantly greater in the standardized group from 0 to 6 months (difference between groups, 92.3 [95% CI, 0.9-183.8] kcal/d; P = .05). Conclusions and Relevance:A personalized diet targeting a reduction in PPGR did not result in greater weight loss compared with a low-fat diet at 6 months. Future studies should assess methods of increasing dietary self-monitoring adherence and intervention exposure. Trial Registration:ClinicalTrials.gov Identifier: NCT03336411.
PMID: 36169954
ISSN: 2574-3805
CID: 5334302