Incidence and Predictors of Breakthrough and Severe Breakthrough Infections of SARS-CoV-2 After Primary Series Vaccination in Adults: A Population-Based Survey of 22 575 Participants.

BACKGROUND: Breakthrough infections of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are well documented. The current study estimates breakthrough incidence across pandemic waves, and evaluates predictors of breakthrough and severe breakthrough infections (defined as those requiring hospitalization). METHODS: In total, 89 762 participants underwent longitudinal antibody surveillance. Incidence rates were calculated using total person-days contributed. Bias-corrected and age-adjusted logistic regression determined multivariable predictors of breakthrough and severe breakthrough infection, respectively. RESULTS: The incidence was 0.45 (95% confidence interval [CI], .38-.50) during pre-Delta, 2.80 (95% CI, 2.25-3.14) during Delta, and 11.2 (95% CI, 8.80-12.95) during Omicron, per 10 000 person-days. Factors associated with elevated odds of breakthrough included Hispanic ethnicity (vs non-Hispanic white, OR = 1.243; 95% CI, 1.073-1.441), larger household size (OR = 1.251 [95% CI, 1.048-1.494] for 3-5 vs 1 and OR = 1.726 [95% CI, 1.317-2.262] for more than 5 vs 1 person), rural versus urban living (OR = 1.383; 95% CI, 1.122-1.704), receiving Pfizer or Johnson & Johnson versus Moderna, and multiple comorbidities. Of the 1700 breakthrough infections, 1665 reported on severity; 112 (6.73%) were severe. Higher body mass index, Hispanic ethnicity, vaccine type, asthma, and hypertension predicted severe breakthroughs. CONCLUSIONS: Breakthrough infection was 4-25 times more common during the Omicron-dominant wave versus earlier waves. Higher burden of severe breakthrough infections was identified in subgroups.

Antibody Duration After Infection From SARS-CoV-2 in the Texas Coronavirus Antibody Response Survey.

Understanding the duration of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus that causes COVID-19 is important to controlling the current pandemic. Participants from the Texas Coronavirus Antibody Response Survey (Texas CARES) with at least 1 nucleocapsid protein antibody test were selected for a longitudinal analysis of antibody duration. A linear mixed model was fit to data from participants (n = 4553) with 1 to 3 antibody tests over 11 months (1 October 2020 to 16 September 2021), and models fit showed that expected antibody response after COVID-19 infection robustly increases for 100 days postinfection, and predicts individuals may remain antibody positive from natural infection beyond 500 days depending on age, body mass index, smoking or vaping use, and disease severity (hospitalized or not; symptomatic or not).

Long-term immune response to SARS-CoV-2 infection and vaccination in children and adolescents.

BACKGROUND: This analysis examined the durability of antibodies present after SARS-CoV-2 infection and vaccination in children and adolescents. METHODS: Data were collected over 4 time points between October 2020-November 2022 as part of a prospective population-based cohort aged 5-to-19 years (N = 810). Results of the (1) Roche Elecsys® Anti-SARS-CoV-2 Immunoassay for detection of antibodies to the SARS-CoV-2 nucleocapsid protein (Roche N-test); and (2) qualitative and semi-quantitative detection of antibodies to the SARS CoV-2 spike protein receptor binding domain (Roche S-test); and (3) self-reported antigen/PCR COVID-19 test results, vaccination and symptom status were analyzed. RESULTS: N antibody levels reached a median of 84.10 U/ml (IQR: 20.2, 157.7) cutoff index (COI) ~ 6 months post-infection and increased slightly to a median of 85.25 (IQR: 28.0, 143.0) COI at 12 months post-infection. Peak S antibody levels were reached at a median of 2500 U/mL ~6 months post-vaccination and remained for ~12 months (mean 11.6 months, SD 1.20). CONCLUSIONS: This analysis provides evidence of robust durability of nucleocapsid and spike antibodies in a large pediatric sample up to 12 months post-infection/vaccination. This information can inform pediatric SARS-CoV-2 vaccination schedules. IMPACT: This study provided evidence of robust durability of both nucleocapsid and spike antibodies in a large pediatric sample up to 12 months after infection. Little is known about the long-term durability of natural and vaccine-induced SARS-CoV-2 antibodies in the pediatric population. Here, we determined the durability of anti-SARS-CoV-2 spike (S-test) and nucleocapsid protein (N-test) in children/adolescents after SARS-CoV-2 infection and/or vaccination lasts at least up to 12 months. This information can inform future SARS-CoV-2 vaccination schedules in this age group.

School-based gardening, cooking and nutrition intervention increased vegetable intake but did not reduce BMI: Texas sprouts - a cluster randomized controlled trial.

BACKGROUND: Although school garden programs have been shown to improve dietary behaviors, there has not been a cluster-randomized controlled trial (RCT) conducted to examine the effects of school garden programs on obesity or other health outcomes. The goal of this study was to evaluate the effects of a one-year school-based gardening, nutrition, and cooking intervention (called Texas Sprouts) on dietary intake, obesity outcomes, and blood pressure in elementary school children. METHODS: This study was a school-based cluster RCT with 16 elementary schools that were randomly assigned to either the Texas Sprouts intervention (n = 8 schools) or to control (delayed intervention, n = 8 schools). The intervention was one school year long (9 months) and consisted of: a) Garden Leadership Committee formation; b) a 0.25-acre outdoor teaching garden; c) 18 student gardening, nutrition, and cooking lessons taught by trained educators throughout the school-year; and d) nine monthly parent lessons. The delayed intervention was implemented the following academic year and received the same protocol as the intervention arm. Child outcomes measured were anthropometrics (i.e., BMI parameters, waist circumference, and body fat percentage via bioelectrical impedance), blood pressure, and dietary intake (i.e., vegetable, fruit, and sugar sweetened beverages) via survey. Data were analyzed with complete cases and with imputations at random. Generalized weighted linear mixed models were used to test the intervention effects and to account for clustering effect of sampling by school. RESULTS: A total of 3135 children were enrolled in the study (intervention n = 1412, 45%). Average age was 9.2 years, 64% Hispanic, 47% male, and 69% eligible for free and reduced lunch. The intervention compared to control resulted in increased vegetable intake (+ 0.48 vs. + 0.04 frequency/day, p = 0.02). There were no effects of the intervention compared to control on fruit intake, sugar sweetened beverages, any of the obesity measures or blood pressure. CONCLUSION: While this school-based gardening, nutrition, and cooking program did not reduce obesity markers or blood pressure, it did result in increased vegetable intake. It is possible that a longer and more sustained effect of increased vegetable intake is needed to lead to reductions in obesity markers and blood pressure. CLINICAL TRIALS NUMBER: NCT02668744 .

Factor Structure of a Spanish Translation of an Obesity-Specific Parent-Report Measure of Health-Related Quality of Life.

Objective: Latino youth are disproportionately affected by pediatric obesity and consequently experience impaired health-related quality of life (HRQOL). Although many caregivers of Latino youth do not speak English fluently, no validated Spanish translations of obesity-specific HRQOL measures exist for this population. Therefore, non-English-speaking Latino parents have typically been excluded from analyses related to HRQOL. This study assesses the factor structure of a Spanish translation of a parent-report measure of obesity-specific HRQOL, Sizing Them Up, in a treatment-seeking sample of children with obesity. Methods: Structural equation modeling was used to assess the factor structure of the 6-subscale, 22-item Sizing Them Up measure in 154 parents of treatment-seeking Latino youth (5-18 years of age). Analyses exploring internal consistency and convergent validity were also conducted. Results: Acceptable measurement fit was achieved for the six-factor solution. However, the higher-order model assessing Total HRQOL did not reach acceptable levels, as results found that the Positive Social Attributes (PSA) subscale was not representative of Total HRQOL; internal consistency and convergent validity results also supported this finding. Conclusions: The current study provides support for the utility of a modified version of Sizing Them Up, excluding the PSA Scale, as a parent-report measure of obesity-specific HRQOL in treatment-seeking Latino youth with obesity.

Development and use of an index for measuring implementation of a weight management program in children in primary care clinics in Texas.

BACKGROUND: The Texas Childhood Obesity Research Demonstration study was an integrated, systems-oriented intervention that incorporated primary and secondary obesity prevention approaches targeting multiple sectors, including primary care clinics, to address childhood obesity. The primary care clinic component included the American Academy of Pediatrics' Next Steps weight management counseling materials that support brief healthy lifestyle-focused visits. The current study describes the methodology and assesses the implementation of the Next Steps program in the participating primary care clinics, as well as the association of implementation with enrollment of children with overweight and obesity in the secondary prevention intervention. METHODS: The study used a serial cross-sectional study design to collect data from 11 primary care clinics in Houston (n = 5) and Austin (n = 6), Texas, in 2013-2014. Responses of primary care providers on 42 self-reported survey questions assessing acceptability, adoption, appropriateness, and feasibility of the program were utilized to create a mean standardized clinic implementation index score. Provider scores were aggregated to represent Next Steps implementation scores at the clinic level. A mixed effects logistic regression test was conducted to determine the association between program implementation and the enrollment of children in the secondary prevention. RESULTS: Mean implementation index score was lower at Year 2 of implementation (2014) than Year 1 (2013) although the decrease was not significant [63.2% (12.2%) in 2013 vs. 55.3% (16.5%) in 2014]. There were no significant associations between levels of implementation of Next Steps and enrollment into TX CORD secondary prevention study. CONCLUSIONS: The development of an index using process evaluation measures can be used to assess the implementation and evaluation of provider-based obesity prevention tools in primary care clinics.

Strategies to Recruit a Diverse Low-Income Population to Child Weight Management Programs From Primary Care Practices.

PURPOSE AND OBJECTIVES: Primary care practices can be used to engage children and families in weight management programs. The Texas Childhood Obesity Research Demonstration (TX CORD) study targeted patients at 12 primary care practices in diverse and low-income areas of Houston, Texas, and Austin, Texas for recruitment to a trial of weight management programs. This article describes recruitment strategies developed to benefit both families and health care practices and the modification of electronic health records (EHRs) to reflect recruitment outcomes. INTERVENTION APPROACH: To facilitate family participation, materials and programs were provided in English and Spanish, and programs were conducted in convenient locations. To support health care practices, EHRs and print materials were provided to facilitate obesity recognition, screening, and study referral. We provided brief training for providers and their office staffs that covered screening patients for obesity, empathetic communication, obesity billing coding, and use of counseling materials. EVALUATION METHODS: We collected EHR data from 2012 through 2014, including demographics, weight, and height, for all patients aged 2 to 12 years who were seen in the 12 provider practices during the study's recruitment phase. The data of patients with a body mass index (BMI) at or above the 85th percentile were compared with the same data for patients who were referred to the study and patients who enrolled in the study. We also examined reasons that patients referred to the study declined to participate. RESULTS: Overall, 26% of 7,845 patients with a BMI at or above the 85th percentile were referred to the study, and 27% of referred patients enrolled. Enrollment among patients with a BMI at or above the 85th percentile was associated with being Hispanic and with more severe obesity than with patients of other races/ethnicities or less severe obesity, respectively. Among families of children aged 2 to 5 years who were referred, 20% enrolled, compared with 30% of families of older children (>5 y to 12 y). Referral rates varied widely among the 12 primary care practices, and referral rates were not associated with EHR modifications. IMPLICATIONS FOR PUBLIC HEALTH: Engagement and recruitment strategies for enrolling families in primary care practice in weight management programs should be strengthened. Further study of factors associated with referral and enrollment, better systems for EHR tools, and data on provider and office adherence to study protocols should be examined. EHRs can track referral and enrollment to capture outcomes of recruitment efforts.

Predictors of Severe Obesity in Low-Income, Predominantly Hispanic/Latino Children: The Texas Childhood Obesity Research Demonstration Study.

INTRODUCTION: The objective of this study was to identify predictors of severe obesity in a low-income, predominantly Hispanic/Latino sample of children in Texas. METHODS: This cross-sectional analysis examined baseline data on 517 children from the secondary prevention component of the Texas Childhood Obesity Research Demonstration (TX CORD) study; data were collected from September 2012 through February 2014. Self-administered surveys were used to collect data from parents of children who were aged 2 to 12 years, had a body mass index (BMI) in the 85th percentile or higher, and resided in Austin, Texas, or Houston, Texas. Multivariable logistic regression models adjusted for sociodemographic covariates were used to examine associations of children's early-life and maternal factors (large-for-gestational-age, exclusive breastfeeding for ≥4 months, maternal severe obesity [BMI ≥35.0 kg/m2]) and children's behavioral factors (fruit and vegetable consumption, physical activity, screen time) with severe obesity (BMI ≥120% of 95th percentile), by age group (2-5 y, 6-8 y, and 9-12 y). RESULTS: Across all ages, 184 (35.6%) children had severe obesity. Among children aged 9 to 12 years, large-for-gestational-age at birth (odds ratio [OR] = 2.31; 95% confidence interval [CI], 1.13-4.73) was significantly associated with severe obesity. Maternal severe obesity was significantly associated with severe obesity among children aged 2 to 5 years (OR = 2.67; 95% CI, 1.10-6.47) and 9 to 12 years (OR = 4.12; 95% CI, 1.84-9.23). No significant association was observed between behavioral factors and severe obesity in any age group. CONCLUSION: In this low-income, predominantly Hispanic/Latino sample of children, large-for-gestational-age and maternal severe obesity were risk factors for severe obesity among children in certain age groups. Promoting healthy lifestyle practices during preconception and prenatal periods could be an important intervention strategy for addressing childhood obesity.

Prozone masks elevated SARS-CoV-2 antibody level measurements.

We report a prozone effect in measurement of SARS-CoV-2 spike protein antibody levels from an antibody surveillance program. Briefly, the prozone effect occurs in immunoassays when excessively high antibody concentration disrupts the immune complex formation, resulting in a spuriously low reported result. Following participant inquiries, we observed anomalously low measurement of SARS-CoV-2 spike protein antibody levels using the Roche Elecsys® Anti-SARS-CoV-2 S immunoassay from participants in the Texas Coronavirus Antibody Research survey (Texas CARES), an ongoing prospective, longitudinal antibody surveillance program. In July, 2022, samples were collected from ten participants with anomalously low results for serial dilution studies, and a prozone effect was confirmed. From October, 2022 to March, 2023, serial dilution of samples detected 74 additional cases of prozone out of 1,720 participants' samples. Prozone effect may affect clinical management of at-risk populations repeatedly exposed to SARS-CoV-2 spike protein through multiple immunizations or serial infections, making awareness and mitigation of this issue paramount.

Baseline characteristics of SARS-CoV-2 vaccine non-responders in a large population-based sample.

INTRODUCTION: Studies indicate that individuals with chronic conditions and specific baseline characteristics may not mount a robust humoral antibody response to SARS-CoV-2 vaccines. In this paper, we used data from the Texas Coronavirus Antibody REsponse Survey (Texas CARES), a longitudinal state-wide seroprevalence program that has enrolled more than 90,000 participants, to evaluate the role of chronic diseases as the potential risk factors of non-response to SARS-CoV-2 vaccines in a large epidemiologic cohort. METHODS: A participant needed to complete an online survey and a blood draw to test for SARS-CoV-2 circulating plasma antibodies at four-time points spaced at least three months apart. Chronic disease predictors of vaccine non-response are evaluated using logistic regression with non-response as the outcome and each chronic disease + age as the predictors. RESULTS: As of April 24, 2023, 18,240 participants met the inclusion criteria; 0.58% (N = 105) of these are non-responders. Adjusting for age, our results show that participants with self-reported immunocompromised status, kidney disease, cancer, and "other" non-specified comorbidity were 15.43, 5.11, 2.59, and 3.13 times more likely to fail to mount a complete response to a vaccine, respectively. Furthermore, having two or more chronic diseases doubled the prevalence of non-response. CONCLUSION: Consistent with smaller targeted studies, a large epidemiologic cohort bears the same conclusion and demonstrates immunocompromised, cancer, kidney disease, and the number of diseases are associated with vaccine non-response. This study suggests that those individuals, with chronic diseases with the potential to affect their immune system response, may need increased doses or repeated doses of COVID-19 vaccines to develop a protective antibody level.

Factors associated with elevated SARS-CoV-2 immune response in children and adolescents.

Background: Understanding the distinct immunologic responses to SARS-CoV-2 infection among pediatric populations is pivotal in navigating the COVID-19 pandemic and informing future public health strategies. This study aimed to identify factors associated with heightened antibody responses in children and adolescents to identify potential unique immune dynamics in this population. Methods: Data collected between July and December 2023 from the Texas Coronavirus Antibody REsponse Survey (Texas CARES), a statewide prospective population-based antibody survey among 1-to-19-year-old participants, were analyzed. Each participant had the following data available for analysis: (1) Roche Elecsys® Anti-SARS-CoV-2 Immunoassay for Nucleocapsid protein antibodies (Roche N-test), (2) qualitative and semi-quantitative detection of antibodies to the SARS CoV-2 spike protein receptor binding domain (Roche S-test), and (3) self-reported antigen/PCR COVID-19 test results, vaccination, and health status. Statistical analysis identified associations between participant characteristics and spike antibody quartile group. Results: The analytical sample consisted of 411 participants (mean age 12.2 years, 50.6% female). Spike antibody values ranged from a low of 6.3 U/ml in the lowest quartile to a maximum of 203,132.0 U/ml in the highest quartile in the aggregate sample. Older age at test date (OR = 1.22, 95% CI: 1.12, 1.35, p < .001) and vaccination status (primary series/partially vaccinated, one or multiple boosters) showed significantly higher odds of being in the highest spike antibody quartile compared to younger age and unvaccinated status. Conversely, fewer days since the last immunity challenge showed decreased odds (OR = 0.98, 95% CI: 0.96, 0.99, p = 0.002) of being in the highest spike antibody quartile vs. more days since last immunity challenge. Additionally, one out of every three COVID-19 infections were asymptomatic. Conclusions: Older age, duration since the last immunity challenge (vaccine or infection), and vaccination status were associated with heightened spike antibody responses, highlighting the nuanced immune dynamics in the pediatric population. A significant proportion of children/adolescents continue to have asymptomatic infection, which has important public health implications.

SARS-CoV-2 Serostatus and COVID-19 Illness Characteristics by Variant Time Period in Non-Hospitalized Children and Adolescents.

OBJECTIVE: To describe COVID-19 illness characteristics, risk factors, and SARS-CoV-2 serostatus by variant time period in a large community-based pediatric sample. DESIGN: Data were collected prospectively over four timepoints between October 2020 and November 2022 from a population-based cohort ages 5 to 19 years old. SETTING: State of Texas, USA. PARTICIPANTS: Participants ages 5 to 19 years were recruited from large pediatric healthcare systems, Federally Qualified Healthcare Centers, urban and rural clinical practices, health insurance providers, and a social media campaign. EXPOSURE: SARS-CoV-2 infection. MAIN OUTCOME(S) AND MEASURE(S): SARS-CoV-2 antibody status was assessed by the Roche Elecsys® Anti-SARS-CoV-2 Immunoassay for detection of antibodies to the SARS-CoV-2 nucleocapsid protein (Roche N-test). Self-reported antigen or PCR COVID-19 test results and symptom status were also collected. RESULTS: Over half (57.2%) of the sample (N = 3911) was antibody positive. Symptomatic infection increased over time from 47.09% during the pre-Delta variant time period, to 76.95% during Delta, to 84.73% during Omicron, and to 94.79% during the Omicron BA.2. Those who were not vaccinated were more likely (OR 1.71, 95% CI 1.47, 2.00) to be infected versus those fully vaccinated. CONCLUSIONS: Results show an increase in symptomatic COVID-19 infection among non-hospitalized children with each progressive variant over the past two years. Findings here support the public health guidance that eligible children should remain up to date with COVID-19 vaccinations.

Health literacy, self-efficacy, and patients' assessment of medical disclosure and consent documentation.

Informed consent documents are designed to convey the risks of medical procedures to patients, yet they are often difficult to understand; this is especially true for individuals with limited health literacy. An important opportunity for advancing knowledge about health literacy and informed consent involves examining the theoretical pathways that help to explain how health literacy relates to information processing when patients read consent forms. In this study, we proposed and tested a model that positioned self-efficacy as a mediator of the association between health literacy and patients' comprehension and assessment of informed consent documentation. Findings from structured interviews with patients (n = 254) indicated that lower health literacy predicted lower self-efficacy, which predicted feeling less well informed and less prepared, being more confused about the procedure and its hazards, and wanting more information about risks. Incorporating awareness of self-efficacy into disclosure documents and consent conversations may be a useful means of prompting patients to ask questions that can help them make informed decisions about care.

Comparison of Persistent Symptoms Following SARS-CoV-2 Infection by Antibody Status in Nonhospitalized Children and Adolescents.

BACKGROUND: The prevalence of long-term symptoms of coronavirus disease 2019 (COVID-19) in nonhospitalized pediatric populations in the United States is not well described. The objective of this analysis was to examine the presence of persistent COVID symptoms in children by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody status. METHODS: Data were collected between October 2020 and May 2022 from the Texas Coronavirus Antibody REsponse Survey, a statewide prospective population-based survey among 5-90 years old. Serostatus was assessed by the Roche Elecsys Anti-SARS-CoV-2 Immunoassay for detection of antibodies to the SARS-CoV-2 nucleocapsid protein. Self-reported antigen/polymerase chain reaction COVID-19 test results and persistent COVID symptom status/type/duration were collected simultaneously. Risk ratios for persistent COVID symptoms were calculated versus adults and by age group, antibody status, symptom presence/severity, variant, body mass index and vaccine status. RESULTS: A total of 82 (4.5% of the total sample [n = 1813], 8.0% pre-Delta, 3.4% Delta and beyond) participants reported persistent COVID symptoms (n = 27 [1.5%] 4-12 weeks, n = 58 [3.3%] >12 weeks). Compared with adults, all pediatric age groups had a lower risk for persistent COVID symptoms regardless of length of symptoms reported. Additional increased risk for persistent COVID symptoms >12 weeks included severe symptoms with initial infection, not being vaccinated and having unhealthy weight (body mass index ≥85th percentile for age and sex). CONCLUSIONS: These findings highlight the existence of nonhospitalized youth who may also experience persistent COVID symptoms. Children and adolescents are less likely to experience persistent COVID symptoms than adults and more likely to be symptomatic, experience severe symptoms and have unhealthy weight compared with children/adolescents without persistent COVID symptoms.

Deaths in Children and Adolescents Associated With COVID-19 and MIS-C in the United States.

OBJECTIVES: To describe the demographics, clinical characteristics, and hospital course among persons <21 years of age with a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated death. METHODS: We conducted a retrospective case series of suspected SARS-CoV-2-associated deaths in the United States in persons <21 years of age during February 12 to July 31, 2020. All states and territories were invited to participate. We abstracted demographic and clinical data, including laboratory and treatment details, from medical records. RESULTS: We included 112 SARS-CoV-2-associated deaths from 25 participating jurisdictions. The median age was 17 years (IQR 8.5-19 years). Most decedents were male (71, 63%), 31 (28%) were Black (non-Hispanic) persons, and 52 (46%) were Hispanic persons. Ninety-six decedents (86%) had at least 1 underlying condition; obesity (42%), asthma (29%), and developmental disorders (22%) were most commonly documented. Among 69 hospitalized decedents, common complications included mechanical ventilation (75%) and acute respiratory failure (82%). The sixteen (14%) decedents who met multisystem inflammatory syndrome in children (MIS-C) criteria were similar in age, sex, and race and/or ethnicity to decedents without MIS-C; 11 of 16 (69%) had at least 1 underlying condition. CONCLUSIONS: SARS-CoV-2-associated deaths among persons <21 years of age occurred predominantly among Black (non-Hispanic) and Hispanic persons, male patients, and older adolescents. The most commonly reported underlying conditions were obesity, asthma, and developmental disorders. Decedents with coronavirus disease 2019 were more likely than those with MIS-C to have underlying medical conditions.

Who benefits from the intervention? Correlates of successful BMI reduction in the Texas Childhood Obesity Demonstration Project (TX-CORD).

BACKGROUND: Many childhood obesity intervention studies report mean outcomes but do not explore the variation in responses and the characteristics of those who respond well. OBJECTIVE: To identify child and family characteristics associated with improvement in the primary outcome, %BMIp95 , of the Texas Childhood Obesity Research Demonstration project (TX-CORD). METHODS: The 12-month TX-CORD secondary prevention study randomized 549 children, ages 2 to 12 years, with BMI ≥85th percentile to the intensive intervention vs. the comparison program, with measurements at baseline, 3-, and 12-months. A growth mixture model was used to identify mutually exclusive latent %BMIp95 trajectories. Latent class regression tested associations between baseline characteristics and latent class membership. RESULTS: A 2-class solution emerged after accounting for the effect of intervention randomization. Latent Class 1 participants (86% of sample) were characterized by mild-to-moderate obesity and demonstrated a significantly greater response to the intensive intervention between 0 and 3 months (slope-on-group = -0.931, p = 0.03). A rebound between 3 and 12 months was not significantly different between arms. Latent Class 2 participants (14%), who had severe obesity, demonstrated no difference in response between intervention groups. Characteristics associated with Class 1 membership included younger age (2-5 years vs. 6-12 years: OR 3.70, p = .035) and lower maternal BMI category (< 35 kg/m2 vs. ≥ 35 kg/m2 : OR 7.14, p < .0001). CONCLUSIONS: The optimal target population for the intensive intervention are children who have milder obesity, are younger, and do not have a mother with severe obesity. Children with severe obesity may require different approaches.

Evaluation of BMI Metrics to Assess Change in Adiposity in Children with Overweight and Moderate and Severe Obesity.

OBJECTIVE: This study aimed to examine the relation between change in different BMI metrics and change in adiposity over a 12-month weight management intervention. METHODS: Baseline and 12-month weights and heights from 399 children aged 2 to 12 years with BMI ≥ 85th percentile were used to calculate BMI, %BMIp95, %BMIp50, BMI z-score (BMIz), and modified BMI z-score (BMImz). Changes (Δ) in these measures were compared with changes in body fat percent (Δfat%) from bioelectrical impedance assessment. Correlation and regression models predicting associations between ΔBMI metrics and Δfat% were examined. RESULTS: A total of 89% of the cohort was Hispanic, and 34% had class 2 or 3 obesity. In models predicting Δfat% adjusting for age, sex, and weight category, R2 for ΔBMI, ΔBMIz, BMImz, Δ%BMIp95, and Δ%BMIp50 were 0.53, 0.38, 0.45, 0.53, and 0.54, respectively (all P < 0.001). Only the ΔBMIz model had an interaction with weight status. Among the models with the highest R2, age group and sex interacted with the Δ%BMIp95 model but not ΔBMI or ΔBMIp50 models. CONCLUSIONS: Longitudinal analyses demonstrate the utility of several BMI metrics other than z-score in capturing adiposity change consistently across a range of obesity severity. Characteristics of studied groups and interpretability could influence metric choice.

National rates of diarrhea-associated ambulatory visits in children.

OBJECTIVE: To estimate national rates of ambulatory healthcare visits due to diarrhea- and rotavirus-associated illness before the introduction of rotavirus vaccine. STUDY DESIGN: Annual rates for diarrhea-associated visits in children age < 5 years were calculated for 1995-2004 using National Ambulatory Medical Care Survey, National Hospital Ambulatory Medical Care Survey, and US Census Bureau data. Rates by age, race, and time period were compared using Poisson regression. RESULTS: Annual rates of outpatient and emergency department (ED) visits for 1995-2004 were 955 (95% confidence interval [CI] = 803 to 1107) and 314 (95% CI = 278 to 350)/10,000 person-years, respectively. Annual outpatient (P = .470) and ED (P = .734) visit rates remained stable from 1995 to 2004. Outpatient visits were less frequent in African Americans than Caucasians (716/10,000 person-years vs 1012/10,000 person-years; P < .05; incidence rate ratio [IRR] = 0.71; 95% CI = 0.51 to 0.99), whereas ED visits were more frequent in African Americans than Caucasians (520/10,000 person-years vs 286/10,000 person-years; P < .05; IRR = 1.83; 95% CI = 1.58 to 2.11). Approximately 29% of outpatient diarrhea-associated outpatient visits (273/10,000 person-years; 95% CI = 145 to 401) and 25% of diarrhea-associated ED visits (78/10,000 person-years; 95% CI = 64 to 83) were due to rotavirus. CONCLUSIONS: Diarrhea- and rotavirus-associated illness is associated with significant healthcare utilization. Future studies are needed to investigate factors causing differences in healthcare use by race and to explore the impact of the rotavirus vaccine.

Design and participant characteristics of TX sprouts: A school-based cluster randomized gardening, nutrition, and cooking intervention.

AIMS: To outline the study design, outcome measures, protocol and baseline characteristics of enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial. METHODS: Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to the delayed intervention over three years (2016-2019). The intervention arm received: formation/training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly during school hours by hired educators throughout one school year; and nine parent lessons taught monthly to families. The delayed intervention was implemented the following academic year and received the same protocol as the intervention arm. Primary outcomes included: dietary intake, dietary-related behaviors, obesity, and metabolic parameters. Child measures included: height, weight, waist circumference, body composition, blood pressure, and dietary psychosocial variables. A subsample of children were measured for glucose, hemoglobin-A1C, and 24-hour dietary recalls. Parent measures included: height and weight, dietary intake, and related dietary psychosocial variables. RESULTS: Of the 4239 eligible students, 3137 students consented and provided baseline clinical measures; 3132 students completed child surveys, with 92% of their parents completing parent surveys. The subsamples of blood draws and dietary recalls were 34% and 24%, respectively. Intervention arm baseline descriptives, clinical and dietary data for children and parents are reported. CONCLUSION: The TX Sprouts intervention targeted primarily low-income Hispanic children and their parents; utilized an interactive gardening, nutrition, and cooking program; and measured a battery of dietary behaviors, obesity and metabolic outcomes.

Trends in healthcare usage attributable to diarrhea, 1995-2004.

OBJECTIVE: To determine current diarrhea-associated healthcare usage rates and associated sociodemographic factors. These data can be used to determine the impact of the rotavirus vaccine. STUDY DESIGN: Using discharge diagnosis codes, we determined diarrhea-associated visit rates for children aged 0 to 18 years enrolled in Tennessee Medicaid, 1995-2004. Poisson regression compared data across time and within strata. The winter residual excess method estimated the rotavirus burden. RESULTS: Analyzing approximately 500 000 person-years annually, outpatient and hospitalization rates remained stable from 1995 to 2004; emergency department (ED) rates approximately doubled, incidence rate ratio (IRR): 1.92 (1.81-2.04). White children used healthcare at greater rates than black children: outpatient IRR 1.90: (1.85-1.95), ED IRR: 1.69 (1.64-1.74), and inpatient IRR: 1.82 (1.73-1.92); and rural children greater than urban: outpatient IRR 1.66 (1.62-1.70), ED IRR 1.14 (1.11-1.17), inpatient IRR 1.88 (1.80-1.97). Children aged 0 to 35 months experienced 1627 outpatient and 792 ED visits, and 148 hospitalizations per 10 000 child-years; rotavirus may have affected up to 40% of these hospitalizations. CONCLUSIONS: Diarrhea-associated ED visit rates nearly doubled from 1995 to 2004. Future studies could explore factors resulting in increased healthcare usage by white children and those living in rural areas and document the rotavirus vaccine's impact after its release.