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.

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.

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.

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.

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).

Methodology to estimate natural- and vaccine-induced antibodies to SARS-CoV-2 in a large geographic region.

Accurate estimates of natural and/or vaccine-induced antibodies to SARS-CoV-2 are difficult to obtain. Although model-based estimates of seroprevalence have been proposed, they require inputting unknown parameters including viral reproduction number, longevity of immune response, and other dynamic factors. In contrast to a model-based approach, the current study presents a data-driven detailed statistical procedure for estimating total seroprevalence (defined as antibodies from natural infection or from full vaccination) in a region using prospectively collected serological data and state-level vaccination data. Specifically, we conducted a longitudinal statewide serological survey with 88,605 participants 5 years or older with 3 prospective blood draws beginning September 30, 2020. Along with state vaccination data, as of October 31, 2021, the estimated percentage of those 5 years or older with naturally occurring antibodies to SARS-CoV-2 in Texas is 35.0% (95% CI = (33.1%, 36.9%)). This is 3× higher than, state-confirmed COVID-19 cases (11.83%) for all ages. The percentage with naturally occurring or vaccine-induced antibodies (total seroprevalence) is 77.42%. This methodology is integral to pandemic preparedness as accurate estimates of seroprevalence can inform policy-making decisions relevant to SARS-CoV-2.

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.

Strategies to Estimate Prevalence of SARS-CoV-2 Antibodies in a Texas Vulnerable Population: Results From Phase I of the Texas Coronavirus Antibody Response Survey.

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and immunity remains uncertain in populations. The state of Texas ranks 2nd in infection with over 2.71 million cases and has seen a disproportionate rate of death across the state. The Texas CARES project was funded by the state of Texas to estimate the prevalence of SARS-CoV-2 antibody status in children and adults. Identifying strategies to understand natural as well as vaccine induced antibody response to COVID-19 is critical. Materials and Methods: The Texas CARES (Texas Coronavirus Antibody Response Survey) is an ongoing prospective population-based convenience sample from the Texas general population that commenced in October 2020. Volunteer participants are recruited across the state to participate in a 3-time point data collection Texas CARES to assess antibody response over time. We use the Roche Elecsys® Anti-SARS-CoV-2 Immunoassay to determine SARS-CoV-2 antibody status. Results: The crude antibody positivity prevalence in Phase I was 26.1% (80/307). The fully adjusted seroprevalence of the sample was 31.5%. Specifically, 41.1% of males and 21.9% of females were seropositive. For age categories, 33.5% of those 18-34; 24.4% of those 35-44; 33.2% of those 45-54; and 32.8% of those 55+ were seropositive. In this sample, 42.2% (89/211) of those negative for the antibody test reported having had a COVID-19 test. Conclusions: In this survey we enrolled and analyzed data for 307 participants, demonstrating a high survey and antibody test completion rate, and ability to implement a questionnaire and SARS-CoV-2 antibody testing within clinical settings. We were also able to determine our capability to estimate the cross-sectional seroprevalence within Texas's federally qualified community centers (FQHCs). The crude positivity prevalence for SARS-CoV-2 antibodies in this sample was 26.1% indicating potentially high exposure to COVID-19 for clinic employees and patients. Data will also allow us to understand sex, age and chronic illness variation in seroprevalence by natural and vaccine induced. These methods are being used to guide the completion of a large longitudinal survey in the state of Texas with implications for practice and population health.

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.

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 .

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.

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.

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.

Behavior Modification of Diet and Parent Feeding Practices in a Community- Vs Primary Care-Centered Intervention for Childhood Obesity.

OBJECTIVE: To evaluate behavior modification of diet and parent feeding practices in childhood obesity interventions. DESIGN: Secondary analysis of randomized, controlled trial comparing Mind, Exercise, Nutrition … Do It! (MEND2-5 and MEND/Coordinated Approach to Child Health [CATCH6-12]) vs Next Steps at baseline and 3 and 12 months. SETTING: Austin and Houston, TX. PARTICIPANTS: A total of 549 Hispanic and black children randomized to programs by age groups (2-5, 6-8, and 9-12 years) INTERVENTIONS: Twelve-month MEND2-5 and MEND/CATCH6-12 vs Next Steps. MAIN OUTCOME MEASURE(S): Diet (MEND-friendly/unfriendly food groups and Healthy Eating Index-2010) and parent feeding practices (parental overt control, discipline, limit setting, monitoring, reinforcement, modeling, and covert control; and food neophobia). ANALYSIS: Mixed-effects linear regression. RESULTS: Changes in diet quality, consumption of MEND-unfriendly foods, and parent feeding practices did not differ between programs. In both interventions, MEND-unfriendly vegetables, grains, dairy and protein, added fat and desserts/sugar-sweetened beverages declined in 2-5- and 6-8-year-olds (P < .001). Healthy Eating Index-2010 improved in 2-5- (treatment; P = .002) and 6-8-year-olds (P = .001). Parental overt control decreased and limit setting, discipline, monitoring, reinforcement, and covert control increased with both interventions in 2-5- and 6-8-year-olds (P < 0.01-0.001). CONCLUSIONS: Diet quality, consumption of MEND-unfriendly foods, and parent feeding practices were altered constructively in 2 pediatric obesity interventions, especially in 2-5- and 6-8-year-olds.

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.

Improvement in Primary Care Provider Self-Efficacy and Use of Patient-Centered Counseling To Address Child Overweight and Obesity after Practice-Based Changes: Texas Childhood Obesity Research Demonstration Study.

BACKGROUND: The Texas Childhood Obesity Research Demonstration project, a multicenter, multisystem approach to childhood overweight and obesity (OW/OB), included training and materials to support primary care clinics (PCCs) in addressing child OW/OB in the office. This study evaluated the impact over 24 months of brief training and practice-based support on primary care providers' (PCPs) perceived self-efficacy and practice behaviors. METHODS: The PCPs at five Houston and seven Austin PCCs completed questionnaires at baseline (2012, n = 36), 12 months (2013, n = 30), and 24 months (2014, n = 34) follow-up. Mixed-effects linear regression models were used to compare changes in self-efficacy (15 items, responses 1-4: not at all confident to very confident) and practice behaviors (30 items, responses 0-4: never to always) in obesity-related screening and counseling, and to assess association between prior training and these outcomes. RESULTS: Self-efficacy items for identification of (2.9 [0.1] vs. 3.3 [0.1]) and counseling about (2.8 [0.1] vs. 3.4 [0.1]) OW/OB-related parenting practices, and setting behavioral goals (2.9 [0.2] vs. 3.3 [0.2]) improved significantly (p < 0.05) between baseline and 24-month follow-up. Self-efficacy items with "confident" mean baseline scores that further improved included determining child OW/OB (3.6 [0.1] vs. 3.9 [0.1]) and interpreting BMI (3.6 [0.1] vs. 3.9 [0.1]). At all measurements, PCPs reported frequently addressing medical problems and lifestyle behaviors. Use of patient-centered counseling techniques, which was low at baseline, increased significantly, including asking permission before discussing lifestyle (1.5 [0.3] vs. 2.4 [0.3]). Prior training was associated with improved self-efficacy. CONCLUSIONS: The improvement in PCPs' self-efficacy and patient-centered counseling to address childhood OW/OB supports implementation of brief training and practice support in clinics that serve Medicaid-eligible children.