Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design
Gross, Rachel S; Thaweethai, Tanayott; Rosenzweig, Erika B; Chan, James; Chibnik, Lori B; Cicek, Mine S; Elliott, Amy J; Flaherman, Valerie J; Foulkes, Andrea S; Gage Witvliet, Margot; Gallagher, Richard; Gennaro, Maria Laura; Jernigan, Terry L; Karlson, Elizabeth W; Katz, Stuart D; Kinser, Patricia A; Kleinman, Lawrence C; Lamendola-Essel, Michelle F; Milner, Joshua D; Mohandas, Sindhu; Mudumbi, Praveen C; Newburger, Jane W; Rhee, Kyung E; Salisbury, Amy L; Snowden, Jessica N; Stein, Cheryl R; Stockwell, Melissa S; Tantisira, Kelan G; Thomason, Moriah E; Truong, Dongngan T; Warburton, David; Wood, John C; Ahmed, Shifa; Akerlundh, Almary; Alshawabkeh, Akram N; Anderson, Brett R; Aschner, Judy L; Atz, Andrew M; Aupperle, Robin L; Baker, Fiona C; Balaraman, Venkataraman; Banerjee, Dithi; Barch, Deanna M; Baskin-Sommers, Arielle; Bhuiyan, Sultana; Bind, Marie-Abele C; Bogie, Amanda L; Bradford, Tamara; Buchbinder, Natalie C; Bueler, Elliott; Bükülmez, Hülya; Casey, B J; Chang, Linda; Chrisant, Maryanne; Clark, Duncan B; Clifton, Rebecca G; Clouser, Katharine N; Cottrell, Lesley; Cowan, Kelly; D'Sa, Viren; Dapretto, Mirella; Dasgupta, Soham; Dehority, Walter; Dionne, Audrey; Dummer, Kirsten B; Elias, Matthew D; Esquenazi-Karonika, Shari; Evans, Danielle N; Faustino, E Vincent S; Fiks, Alexander G; Forsha, Daniel; Foxe, John J; Friedman, Naomi P; Fry, Greta; Gaur, Sunanda; Gee, Dylan G; Gray, Kevin M; Handler, Stephanie; Harahsheh, Ashraf S; Hasbani, Keren; Heath, Andrew C; Hebson, Camden; Heitzeg, Mary M; Hester, Christina M; Hill, Sophia; Hobart-Porter, Laura; Hong, Travis K F; Horowitz, Carol R; Hsia, Daniel S; Huentelman, Matthew; Hummel, Kathy D; Irby, Katherine; Jacobus, Joanna; Jacoby, Vanessa L; Jone, Pei-Ni; Kaelber, David C; Kasmarcak, Tyler J; Kluko, Matthew J; Kosut, Jessica S; Laird, Angela R; Landeo-Gutierrez, Jeremy; Lang, Sean M; Larson, Christine L; Lim, Peter Paul C; Lisdahl, Krista M; McCrindle, Brian W; McCulloh, Russell J; McHugh, Kimberly; Mendelsohn, Alan L; Metz, Torri D; Miller, Julie; Mitchell, Elizabeth C; Morgan, Lerraughn M; Müller-Oehring, Eva M; Nahin, Erica R; Neale, Michael C; Ness-Cochinwala, Manette; Nolan, Sheila M; Oliveira, Carlos R; Osakwe, Onyekachukwu; Oster, Matthew E; Payne, R Mark; Portman, Michael A; Raissy, Hengameh; Randall, Isabelle G; Rao, Suchitra; Reeder, Harrison T; Rosas, Johana M; Russell, Mark W; Sabati, Arash A; Sanil, Yamuna; Sato, Alice I; Schechter, Michael S; Selvarangan, Rangaraj; Sexson Tejtel, S Kristen; Shakti, Divya; Sharma, Kavita; Squeglia, Lindsay M; Srivastava, Shubika; Stevenson, Michelle D; Szmuszkovicz, Jacqueline; Talavera-Barber, Maria M; Teufel, Ronald J; Thacker, Deepika; Trachtenberg, Felicia; Udosen, Mmekom M; Warner, Megan R; Watson, Sara E; Werzberger, Alan; Weyer, Jordan C; Wood, Marion J; Yin, H Shonna; Zempsky, William T; Zimmerman, Emily; Dreyer, Benard P; ,
IMPORTANCE/OBJECTIVE:The prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults. OBSERVATIONS/METHODS:We describe the protocol for the Pediatric Observational Cohort Study of the NIH's REsearching COVID to Enhance Recovery (RECOVER) Initiative. RECOVER-Pediatrics is an observational meta-cohort study of caregiver-child pairs (birth through 17 years) and young adults (18 through 25 years), recruited from more than 100 sites across the US. This report focuses on two of four cohorts that comprise RECOVER-Pediatrics: 1) a de novo RECOVER prospective cohort of children and young adults with and without previous or current infection; and 2) an extant cohort derived from the Adolescent Brain Cognitive Development (ABCD) study (n = 10,000). The de novo cohort incorporates three tiers of data collection: 1) remote baseline assessments (Tier 1, n = 6000); 2) longitudinal follow-up for up to 4 years (Tier 2, n = 6000); and 3) a subset of participants, primarily the most severely affected by PASC, who will undergo deep phenotyping to explore PASC pathophysiology (Tier 3, n = 600). Youth enrolled in the ABCD study participate in Tier 1. The pediatric protocol was developed as a collaborative partnership of investigators, patients, researchers, clinicians, community partners, and federal partners, intentionally promoting inclusivity and diversity. The protocol is adaptive to facilitate responses to emerging science. CONCLUSIONS AND RELEVANCE/CONCLUSIONS:RECOVER-Pediatrics seeks to characterize the clinical course, underlying mechanisms, and long-term effects of PASC from birth through 25 years old. RECOVER-Pediatrics is designed to elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC. The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions. CLINICAL TRIALS.GOV IDENTIFIER/BACKGROUND:Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.
PMCID:11075869
PMID: 38713673
ISSN: 1932-6203
CID: 5658342
Infant Feeding Outcomes from a Culturally-Adapted Early Obesity Prevention Program for Immigrant Chinese American Parents
Duh-Leong, Carol; Au, Loretta; Chang, Lucy Y; Feldman, Naumi M; Pierce, Kristyn A; Mendelsohn, Alan L; Perrin, Eliana M; Sanders, Lee M; Velazquez, Jessica J; Lei, Yuxiao; Xing, Samantha X; Shonna Yin, H
OBJECTIVE:To examine whether a cultural adaptation of an early childhood obesity prevention program promotes healthy infant feeding practices. STUDY DESIGN/METHODS:Prospective quasi-experimental study of a community-engaged multiphasic cultural adaptation of an obesity prevention program set at a federally qualified health center serving immigrant Chinese American parent-child dyads (N=298). In a group of historical controls, we assessed early infant feeding practices (breastfeeding, sugar-sweetened beverage intake) in 6-month-olds and then the same practices alongside early solid food feeding practices (bottle weaning, fruit, vegetable, sugary or salty snack consumption) in 12-month-olds. After implementation, we assessed these practices in an intervention cohort group at 6 and 12 months. We used cross-sectional groupwise comparisons and adjusted regression analyses to evaluate group differences. RESULTS:At 6 months, the intervention group had increased odds of no sugar-sweetened beverage intake (aOR: 5.69 [95% CI: 1.65, 19.63], p=0.006). At 12 months, the intervention group also had increased odds of no sugar-sweetened beverage intake (aOR: 15.22 [95% CI: 6.33, 36.62], p<0.001), increased odds of bottle weaning (aOR: 2.34 [95% CI: 1.05, 5.23], p=0.03), and decreased odds of sugary snack consumption (aOR: 0.36 [0.18, 0.70], p= 0.003). We did not detect improvements in breastfeeding, fruit, vegetable, or salty snack consumption. CONCLUSION/CONCLUSIONS:A cultural adaptation of a primary care-based educational obesity prevention program for immigrant Chinese American families with low-income is associated with certain healthy infant feeding practices. Future studies should evaluate cultural adaptations of more intensive interventions that better address complex feeding practices like breastfeeding and evaluate long-term weight outcomes.
PMID: 38880393
ISSN: 1876-2867
CID: 5671732
Prenatal Risks to Healthy Food Access and High Birthweight Outcomes
Duh-Leong, Carol; Perrin, Eliana M; Heerman, William J; Schildcrout, Jonathan S; Wallace, Shelby; Mendelsohn, Alan L; Lee, David C; Flower, Kori B; Sanders, Lee M; Rothman, Russell L; Delamater, Alan M; Gross, Rachel S; Wood, Charles; Yin, Hsiang Shonna
OBJECTIVE:Infants with high birthweight have increased risk for adverse outcomes at birth and across childhood. Prenatal risks to healthy food access may increase odds of high birthweight. We tested whether having a poor neighborhood food environment and/or food insecurity had associations with high birthweight. METHODS:We analyzed cross-sectional baseline data in Greenlight Plus, an obesity prevention trial across six US cities (n = 787), which included newborns with a gestational age greater than 34 weeks and a birthweight greater than 2500 g. We assessed neighborhood food environment using the Place-Based Survey and food insecurity using the US Household Food Security Module. We performed logistic regression analyses to assess the individual and additive effects of risk factors on high birthweight. We adjusted for potential confounders: infant sex, race, ethnicity, gestational age, birthing parent age, education, income, and study site. RESULTS:Thirty-four percent of birthing parents reported poor neighborhood food environment and/or food insecurity. Compared to those without food insecurity, food insecure families had greater odds of delivering an infant with high birthweight (adjusted odds ratios [aOR] 1.96, 95% confidence intervals [CI]: 1.01, 3.82) after adjusting for poor neighborhood food environment, which was not associated with high birthweight (aOR 1.35, 95% CI: 0.78, 2.34). Each additional risk to healthy food access was associated with a 56% (95% CI: 4%-132%) increase in high birthweight odds. CONCLUSIONS:Prenatal risks to healthy food access may increase high infant birthweight odds. Future studies designed to measure neighborhood factors should examine infant birthweight outcomes in the context of prenatal social determinants of health.
PMID: 37659601
ISSN: 1876-2867
CID: 5618142