Current recommendations suggest that women achieve a healthy weight before becoming pregnant, but evidence supporting the benefits of preconception weight loss are limited and inconsistent, with some evidence of risks. The Maternal Preconception Weight Trajectory (MatTrack) study will evaluate the impact of preconception weight change on maternal, pregnancy, and child outcomes. In this paper, we present methods used to construct the cohort and evaluate baseline characteristics. The MatTrack cohort was derived from electronic health record data from four Kaiser Permanente regions. Inclusion criteria addressed data quality, availability, and enrollment; maternal age (≥18 years); and date (pregnancy onset date in 2006-2020, delivery ≤12/31/2020). Starting body mass index (BMI) was calculated using weight closest to 24 months prior to pregnancy onset date and adult height. Preconception weight change rates from 24 months prior to and through pregnancy onset date were estimated using linear mixed effects models. Descriptive analyses characterized the baseline characteristics of the cohort. The cohort includes 297,592 pregnancies with the full spectrum of starting BMI: underweight (2.3%), normal weight (41.8%), overweight (28.4%); and obesity class I (15.3%), II (7.4%), and III (5.0%). The cohort is demographically diverse, with 8.3% covered by Medicaid; and 44.5%, 9.2%, and 10.9% Hispanic, non-Hispanic Black, or non-Hispanic Asian, respectively. Preconception weight change rates (kg/year) span weight loss to gain, with the greatest loss in those with obesity class III [median (10th, 90th percentile): -0.8 (-9.5, 4.9)] and the greatest gain in those with underweight [median (10th, 90th percentile): 1.1 (-0.7, 3.6)]. Longitudinal data from this cohort of nearly 300,000 linked maternal-child dyads will enable examination of associations between preconception weight loss and pregnancy, maternal, and child health outcomes. Findings will strengthen the evidence base for preconception weight management guidelines. ### Competing Interest Statement The authors have declared no competing interest. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The MatTrack study was reviewed and approved by the Kaiser Permanente Northwest (KPNW) Institutional Review Board (IRB) on October 4, 2021 [protocol number 1813017]. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The datasets generated and analyzed during this study are not publicly available due to sourcing patient-level data from multiple health and data systems, which have restrictions regarding the availability and rerelease of data under cross-institution agreements. Data are available on reasonable request and with permission of all relevant parties from the KP Center for Health Research (contact investigator: Dr. Kimberly K. Vesco Kimberly.K.Vesco{at}kpchr.org).

Introduction and Objective: Although achieving a healthy weight prior to pregnancy is recommended, data on the association between preconception weight changes and pregnancy outcomes are limited. We examined the relationship between preconception weight trajectories and risk of GDM in a large, diverse cohort. Methods: We conducted a retrospective cohort study of 257,017 pregnancies resulting in singleton, live birth at ≥28.0 weeks gestation for whom GDM screening was completed within 4 health care systems. Eligible pregnancies had ≥2 weight measurements in the electronic medical record in the 2 years prior to pregnancy with at least one in each of these periods: 0-12 months and 13-24 months prior to pregnancy onset. Preconception weight change rate was estimated using linear mixed effects trajectory models. GDM diagnosis was determined based on glucose levels from oral glucose tolerance testing. We modeled GDM as a function of preconception weight change, BMI category at the start of the preconception period (<25, 25-<30, ≥30 kg/m2) and covariates (maternal age, race and ethnicity, parity, insurance status, health care system) using a multilevel Poisson model with robust standard errors to estimate relative risk and absolute risk, accounting for multiple pregnancies within women. Results: Of included pregnancies, 62% were parous; 45% were Hispanic, 30% non-Hispanic White, 9% non-Hispanic Black, and 17% other races; and 11.7% had diagnosed GDM. Mean preconception BMI was 27 kg/m2 and 27% had a BMI≥30. Mean rate of weight change in the 2 years prior to pregnancy was +0.44 kg/yr (SD=3.73). Every kg/yr of increased weight was associated with 4.8% greater risk of GDM (RR=1.048, 95% CI [1.044, 1.052]). Adjusted risk of GDM was lower among those who lost weight prior to pregnancy compared to those who gained weight (9% risk of GDM for 5 kg/year loss vs 14.5% for 5 kg/yr gain). Conclusion: In this diverse, U.S. cohort, preconception weight change was positively associated with GDM risk. K.K. Vesco: None. E.S. LeBlanc: None. C.E. Oshiro: None. M. Lee: None. M.C. Leo: Research Support; PreludeDx. M. Mayhew: None. D.R. Young: None. C. McCracken: None. A. Owen-Smith: None. N.A. Rosenquist: None. J. Boone-Heinonen: None. Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD102477)

The association between current use of oral contraceptives (OCs) among women younger than 50 years (n = 306 541), and hormone therapy (HT) among women aged 50 years or older (n = 323 203), and coronavirus 2019 (COVID-19) infection and hospitalization was evaluated in this population-based cohort. Current OC/HT use was recorded monthly using prescription dispensing data. COVID-19 infections were identified from March 2020 through February 2021. COVID-19 infections and hospitalizations were identified through diagnosis codes and laboratory tests. We used weighted generalized estimating equations models to estimate multivariable adjusted odds ratios (aORs) for COVID-19 infection associated with time-varying OC/HT use. Among women with COVID-19, logistic regression models were used to evaluate OC/HT use and COVID-19 hospitalization. Over 12 months, 11 727 (3.8%) women younger than 50 years and 8661 (2.7%) women aged 50 years or older experienced COVID-19 infections. There was no evidence of an association between OC use and infection (aOR = 1.05; 95% CI, 0.97-1.12). There was a modest association between HT use and infection (aOR = 1.19; 95% CI, 1.03-1.38). Women using OCs had a 39% lower risk of hospitalization (aOR = 0.61; 95% CI, 0.38-1.00), but there was no association of HT use with hospitalization (aOR = 0.89; 95% CI, 0.51-1.53). These findings do not suggest a meaningfully greater risk of COVID-19 infection associated with OC or HT use. OC use may be associated with lower COVID-19 hospitalization risk.

We conducted a large surveillance study among members of an integrated healthcare delivery system in Pacific Northwest of the United States to estimate medical costs attributable to medically attended acute gastroenteritis (MAAGE) on the day care was sought and during 30-day follow-up. We used multivariable regression to compare costs of MAAGE and non-MAAGE cases matched on age, gender, and index time. Differences accounted for confounders, including race, ethnicity, and history of chronic underlying conditions. Analyses included 73,140 MAAGE episodes from adults and 18,617 from children who were Kaiser Permanente Northwest members during 2014-2016. Total costs were higher for MAAGE cases relative to non-MAAGE comparators as were costs on the day care was sought and costs during follow-up. Costs of MAAGE are substantial relative to the cost of usual-care medical services, and much of the burden accrues during short-term follow-up.

Little is known about whether diabetes increases the risk of COVID-19 infection and whether measures of diabetes severity are related to COVID-19 outcomes. Investigate diabetes severity measures as potential risk factors for COVID-19 infection and COVID-19 outcomes. In integrated healthcare systems in Colorado, Oregon, and Washington, we identified a cohort of adults on February 29, 2020 (n = 1,086,918) and conducted follow-up through February 28, 2021. Electronic health data and death certificates were used to identify markers of diabetes severity, covariates, and outcomes. Outcomes were COVID-19 infection (positive nucleic acid antigen test, COVID-19 hospitalization, or COVID-19 death) and severe COVID-19 (invasive mechanical ventilation or COVID-19 death). Individuals with diabetes (n = 142,340) and categories of diabetes severity measures were compared with a referent group with no diabetes (n = 944,578), adjusting for demographic variables, neighborhood deprivation index, body mass index, and comorbidities. Of 30,935 patients with COVID-19 infection, 996 met the criteria for severe COVID-19. Type 1 (odds ratio [OR] 1.41, 95% CI 1.27–1.57) and type 2 diabetes (OR 1.27, 95% CI 1.23–1.31) were associated with increased risk of COVID-19 infection. Insulin treatment was associated with greater COVID-19 infection risk (OR 1.43, 95% CI 1.34–1.52) than treatment with non-insulin drugs (OR 1.26, 95% 1.20–1.33) or no treatment (OR 1.24; 1.18–1.29). The relationship between glycemic control and COVID-19 infection risk was dose-dependent: from an OR of 1.21 (95% CI 1.15–1.26) for hemoglobin A1c (HbA1c) < 7% to an OR of 1.62 (95% CI 1.51–1.75) for HbA1c ≥ 9%. Risk factors for severe COVID-19 were type 1 diabetes (OR 2.87; 95% CI 1.99–4.15), type 2 diabetes (OR 1.80; 95% CI 1.55–2.09), insulin treatment (OR 2.65; 95% CI 2.13–3.28), and HbA1c ≥ 9% (OR 2.61; 95% CI 1.94–3.52). Diabetes and greater diabetes severity were associated with increased risks of COVID-19 infection and worse COVID-19 outcomes.

AbstractBackgroundHealthier lifestyles in early pregnancy are associated with lower rates of pregnancy complications, childhood adiposity, and maternal and child cardiovascular risks. However, it is not known whether lifestyle coaching initiated prior to pregnancy can affect behavior and attitudes during pregnancy.MethodsThree hundred and twenty six women planning pregnancy within 2 years with BMI ≥27 kg/m2 were randomized to a behavioral weight loss intervention or to usual care. Analyses reported here examined the intervention’s impact on mid‐pregnancy diet quality and activity levels; program acceptability; and effects of pregnancy on intervention engagement.ResultsOne hundred and sixty eight participants experienced pregnancy during the study (intervention: 91; usual care: 77). From randomization to mid‐pregnancy, participants who received the intervention had larger increases in fruit intake than usual care participants (+0.67 vs. +0.06 cups; p = 0.02) and engaged in more vigorous‐intensity activity (3.9 [5.5] vs. 1.2 [3.0] Met‐hr/week p = 0.002) and sports/exercise (17.0 [14.1] vs. 11.0 [9.5] Met‐hr/week; p = 0.03); the groups also differed in changes in sedentary time (−4.9 [15.0] vs. +0.5 [7.6] Met‐hr/week; p = 0.02). Intervention satisfaction was high (>80%), and experiencing pregnancy during the intervention was associated with higher engagement.ConclusionA coaching‐based intervention beginning in pre‐pregnancy successfully helped women attain healthier diet and exercise habits in mid‐pregnancy.Clinical trials registrationRegistered with ClinicalTrials.gov, NCT02346162, first registered on January 26, 2015, before date of initial participant enrollment (May 2015), https://clinicaltrials.gov/ct2/show/NCT02346162.

Abstract We assessed rotavirus vaccine impact using data on acute gastroenteritis (AGE) encounters within an integrated healthcare delivery system during 2000–2018. Following rotavirus vaccine introduction, all-cause AGE rates among children <5 years declined by 36% (95% confidence interval [CI]: 32%–40%) for outpatient and 54% (95% CI: 46%–60%) for inpatient encounters.

COVID-19 inequities have been well-documented. We evaluated whether higher rates of severe COVID-19 in racial and ethnic minority groups were driven by higher infection rates by evaluating if disparities remained when analyses were restricted to people with infection. We conducted a retrospective cohort study of adults insured through Kaiser Permanente (Colorado, Northwest, Washington), follow-up in March-September 2020. Laboratory results and hospitalization diagnosis codes identified individuals with COVID-19. Severe COVID-19 was defined as invasive mechanical ventilation or mortality. Self-reported race and ethnicity, demographics, and medical comorbidities were extracted from health records. Modified Poisson regression estimated adjusted relative risks (aRRs) of severe COVID-19 in full cohort and among individuals with infection. Our cohort included 1,052,774 individuals, representing diverse racial and ethnic minority groups (e.g., 68,887 Asian, 41,243 Black/African American, 93,580 Hispanic or Latino/a individuals). Among 7,399 infections, 442 individuals experienced severe COVID-19. In the full cohort, severe COVID-19 aRRs for Asian, Black/African American, and Hispanic individuals were 2.09 (95% CI: 1.36, 3.21), 2.02 (1.39, 2.93), and 2.09 (1.57, 2.78), respectively, compared to non-Hispanic Whites. In analyses restricted to individuals with COVID-19, all aRRs were near 1, except among Asian Americans (aRR 1.82 [1.23, 2.68]). These results indicate increased incidence of severe COVID-19 among Black/African American and Hispanic individuals is due to higher infection rates, not increased susceptibility to progression. COVID-19 disparities most likely result from social, not biological, factors. Future work should explore reasons for increased severe COVID-19 risk among Asian Americans. Our findings highlight the importance of equity in vaccine distribution.

Background Anxiety disorders are the most common mental health problem among youth, contribute to reduced quality of daily life, and are associated with high rates of comorbidity. However, treatment rates for anxiety are very low, causing a sizeable treatment gap. There is an immediate need to identify treatment interventions that are effective, affordable, and can be delivered easily to the youth population. Cognitive Bias Modification (CBM) is one potentially effective intervention that could reach youth on a large scale, especially when self-administered at home. Thus, we aim to assess the benefit of CBM to treat youth anxiety. Further, we aim to test whether adding an adherence promotion (AP) component to the CBM intervention can improve outcomes, and whether CBM delivered both with and without the AP component is cost effective. Methods This is a 12-month randomized controlled trial (RCT) conducted within an existing healthcare system. Potentially eligible youth (ages 12 to 17) will be identified by reviewing the electronic health record (EHR) for clinical anxiety diagnoses, which are then confirmed via research interview. We aim to enroll 498 participants and randomize them 1:1:1 to one of three arms: Arm 1 is a Low-Ratio version of the CBM program (nearly identical to the other CBM versions, but minimally effective); Arm 2 is a High-Ratio “active” CBM program; and Arm 3 is the High-Ratio CBM program with an added AP component. Participants will complete assessments at baseline, 1-, 3-, 6- and 12-months post-baseline. Youth in all three arms will self-administer the CBM program at home and will be asked to complete twelve intervention sessions over a four-week period. Arm 3 participants (High-Ratio CBM + AP) will also receive up to four telephone calls from phone coaches during the intervention period to provide technical assistance, encouragement, and motivational enhancement to increase adherence. The primary clinical outcome will be anxiety remission at 6-month follow-up. Discussion This study protocol describes the method and design for an RCT to test whether self-administered CBM both with and without adherence promotion can be an effective at-home treatment for anxious youth. Trial registration ClinicalTrials.gov : NCT02156531, First Posted June 5, 2014.