The Effect of an Obesity Prevention Intervention Among Specific Subpopulations: A Heterogeneity of Treatment Effect Analysis of the Greenlight Trial.

Background: Understanding how different populations respond to a childhood obesity intervention could help optimize personalized treatment strategies, especially with the goal to reduce disparities in obesity. Methods: We conducted a secondary analysis of the Greenlight Cluster Randomized Controlled Trial, a health communication focused pediatric obesity prevention trial, to evaluate for heterogeneity of treatment effect (HTE) by child biological sex, caregiver BMI, caregiver reported race and ethnicity, primary language, and health literacy. To examine HTE on BMI z-score from 2 to 24 months of age, we fit linear mixed effects models. Results: We analyzed 802 caregiver-child pairs, of which 52% of children were female, 58% of households reported annual family income of <$20,000, and 83% did not have a college degree. We observed evidence to suggest HTE by primary language (p = 0.047 for Spanish vs. English) and the combination of primary language and health literacy (p = 0.01). There was insufficient evidence to suggest that the Greenlight intervention effect differed by biological sex, caregiver BMI, or by race/ethnicity. Conclusions: This HTE analysis found that the Greenlight obesity prevention intervention had a more beneficial effect on child BMI z-score over 2 years for children of caregivers with limited health literacy and for caregivers for whom Spanish was the primary language.

The Injury Prevention Program to Reduce Early Childhood Injuries: A Cluster Randomized Trial.

BACKGROUND AND OBJECTIVES: The American Academy of Pediatrics designed The Injury Prevention Program (TIPP) in 1983 to help pediatricians prevent unintentional injuries, but TIPP's effectiveness has never been formally evaluated. We sought to evaluate the impact of TIPP on reported injuries in the first 2 years of life. METHODS: We conducted a stratified, cluster-randomized trial at 4 academic medical centers: 2 centers trained their pediatric residents and implemented TIPP screening and counseling materials at all well-child checks (WCCs) for ages 2 to 24 months, and 2 centers implemented obesity prevention. At each WCC, parents reported the number of child injuries since the previous WCC. Proportional odds logistic regression analyses with generalized estimating equation examined the extent to which the number of injuries reported were reduced at TIPP intervention sites compared with control sites, adjusting for baseline child, parent, and household factors. RESULTS: A total of 781 parent-infant dyads (349 TIPP; 432 control) were enrolled and had sufficient data to qualify for analyses: 51% Hispanic, 28% non-Hispanic Black, and 87% insured by Medicaid. Those at TIPP sites had significant reduction in the adjusted odds of reported injuries compared with non-TIPP sites throughout the follow-up (P = .005), with adjusted odds ratios (95% CI) of 0.77 (0.66-0.91), 0.60 (0.44-0.82), 0.32 (0.16-0.62), 0.26 (0.12-0.53), and 0.27 (0.14-0.52) at 4, 6, 12, 18, and 24 months, respectively. CONCLUSIONS: In this cluster-randomized trial with predominantly low-income, Hispanic, and non-Hispanic Black families, TIPP resulted in a significant reduction in parent-reported injuries. Our study provides evidence for implementing the American Academy of Pediatrics' TIPP in routine well-child care.

Hormonal Contraception and Risk of Cardiometabolic Disease in Women with HIV.

Objective: We sought to determine the association of hormonal contraception (HC) and cardiometabolic outcomes among women with human immunodeficiency virus (HIV). Methods: We included women with HIV aged 18-45 years in clinical care in the Southeastern United States between 1998 and 2018. Oral and injectable HC use was captured from medication records. Our outcomes included incident cardiovascular/thrombotic disease (CVD) (atherosclerosis, hypertension, cerebrovascular disease, thrombosis, and heart failure) and incident metabolic disorders (diabetes, dyslipidemia, obesity, and non-alcoholic steatohepatitis). We excluded women with prevalent conditions. We used multivariable marginal structural models to examine time-varying current and cumulative HC use and cardiometabolic outcomes in separate analyses, adjusting for age, race, smoking, time-varying comorbidities, CD4 cell count, HIV RNA, and antiretroviral use. Women with HC exposure were compared with women without HC exposure. Results: Among the 710 women included, 201 women (28%) used HC. CVD analyses included 603 women without prevalent CVD and 93 incident events; metabolic analyses included 365 women without prevalent metabolic disease and 150 incident events. Current and cumulative oral HC use was associated with increased odds of CVD, though this was not statistically significant (adjusted odds ratio [aOR] = 2.08, [95% confidence interval (CI): 0.80-5.43] and aOR = 1.24 [95% CI: 0.96-1.60] per year of use, respectively). Oral HC was not associated with risk of incident metabolic disorders. Depot medroxyprogesterone acetate (DMPA) was not associated with risk of incident CVD. Current and cumulative DMPA use was significantly associated with decreased odds of incident metabolic disorders (aOR = 0.48 [95% CI: 0.23, 1.00] and aOR = 0.65 [95% CI: 0.42-1.00] per year of use, respectively). Conclusion: Our results suggest that cardiovascular risk should be considered when selecting contraception for women with HIV.

Associations Between Gestational Weight Gain, Gestational Diabetes, and Childhood Obesity Incidence.

INTRODUCTION: Excessive maternal gestational weight gain (GWG) is strongly correlated with childhood obesity, yet how excess maternal weight gain and gestational diabetes mellitus (GDM) interact to affect early childhood obesity is poorly understood. The purpose of this study was to investigate whether overall and trimester-specific maternal GWG and GDM were associated with obesity in offspring by age 6 years. METHODS: A cohort of 10,335 maternal-child dyads was established from electronic health records. Maternal weights at conception and delivery were estimated from weight trajectory fits using functional principal components analysis. Kaplan-Meier curves and Cox regression, together with generalized raking, examined time-to-childhood-obesity. RESULTS: Obesity diagnosed prior to age 6 years was estimated at 19.7% (95% CI: 18.3, 21.1). Maternal weight gain during pregnancy was a strong predictor of early childhood obesity (p < 0.0001). The occurrence of early childhood obesity was lower among mothers with GDM compared with those without diabetes (adjusted hazard ratio = 0.58, p = 0.014). There was no interaction between maternal weight gain and GDM (p = 0.55). Higher weight gain during the first trimester was associated with lower risk of early childhood obesity (p = 0.0002) whereas higher weight gain during the second and third trimesters was associated with higher risk (p < 0.0001). DISCUSSION: Results indicated total and trimester-specific maternal weight gain was a strong predictor of early childhood obesity, though obesity risk by age 6 was lower for children of mothers with GDM. Additional research is needed to elucidate underlying mechanisms directly related to trimester-specific weight gain and GDM that impede or protect against obesity prevalence during early childhood.

Excessive maternal gestational weight gain (GWG) and gestational diabetes mellitus (GDM) have been linked to childhood obesity. Yet, research on how excessive total and trimester-specific GWG and GDM interact to affect early childhood obesity remains inconclusive. This study found that inadequate weight gain in the first trimester and excessive weight gain in the second and third trimester were associated with higher risks of childhood obesity by age 6. No significant interaction between maternal GWG and GDM was noted suggesting that these two important maternal conditions do not have a combined effect on the risk of early childhood obesity.

Characterizing residential mobility among people with HIV in Tennessee and its impact on HIV care outcomes.

OBJECTIVE: Our objective was to assess the prevalence and patterns of mobility among people with HIV (PWH) in Tennessee and its impact on HIV care outcomes. DESIGN: Retrospective cohort study. METHODS: We combined residential address and HIV surveillance data from PWH in Tennessee from 2016 to 2018. Using Poisson regression, we estimated associations between in-state mobility (change in address or total miles moved) in 1 year and outcomes in the subsequent year; retention: having two CD4 + /HIV RNA values (labs) in a calendar year at least 3 months apart, loss to follow-up (LTFU): having labs at baseline but not the subsequent year, and viral suppression: HIV RNA less than 200 copies/ml. We applied a kernel density estimator to origin-destination address lines to visualize mobility patterns across demographic subgroups. RESULTS: Among 17 428 PWH [median age 45 years (interquartile range; IQR 34-53)], 6564 (38%) had at least one move. Median miles moved was 8.9 (IQR 2.6-143.4)). We observed in-state movement between major cities (Chattanooga, Knoxville, Memphis and Nashville) and out-of-state movement to and from Georgia and Florida. Having at least one in-state move was associated with a decreased likelihood of retention [adjusted relative risk (aRR) = 0.91; 95% confidence interval (CI) 0.88-0.95], and an increased risk of LTFU (aRR = 1.17; 95% CI 1.04-1.31, two to three moves vs. none). Greater distance moved in-state was associated with decreased retention and increased LTFU (aRR = 0.53; 95% CI 0.49-0.58, aRR = 2.52; 95% CI 2.25-2.83, respectively for 1000 vs. 0 miles). There was no association between mobility and viral suppression. CONCLUSION: Mobility is common among PWH in Tennessee and is associated with initial poor engagement in HIV care.

TV Time, Especially During Meals, is Associated with Less Healthy Dietary Practices in Toddlers.

BACKGROUND: While several studies examine the relationship between screen time and dietary practices in children and teenagers, there is limited research in toddlers. This study evaluates the association between television (TV) exposure and dietary practices in two-year-old children. METHODS: We conducted a cross-sectional, secondary data analysis from the Greenlight Intervention Study. Toddlers' daily TV watching time, mealtime TV, and dietary practices were assessed by caregiver report at the 24-month well child visit. Separate regression models were used and adjusted for sociodemographic/household characteristics and clinic site. RESULTS: 532 toddlers were included (51% Latino; 30% non-Latino Black; 59% ≤$20,000 annual household income). Median daily TV watching time was 42 minutes [IQR: 25, 60]; 25% reported the TV was "usually on" during mealtimes. After adjustment, toddlers who watched more TV daily had higher odds of consuming sugar-sweetened beverages (SSB), fast food, and more junk food; those watching less TV had higher odds of consuming more fruits/vegetables. Those with the TV "usually on" during mealtimes were more likely to consume SSB [aOR 3.72 (95%CI 2.16-6.43)], fast food [aOR 2.83 (95%CI 1.54-5.20)], and more junk food [aOR 4.25 (95%CI 2.71-6.65)]. CONCLUSIONS: Among toddlers from primarily minoritized populations and of lower socioeconomic status, those who watched more TV daily and usually had the TV on during meals had significantly less healthy dietary practices, even after adjusting for known covariates. This study supports the current American Academy of Pediatrics screen time guidelines and underscores the importance of early counseling on general and mealtime TV.

Variation in missed doses and reasons for discontinuation of anti-tuberculosis drugs during hospital treatment for drug-resistant tuberculosis in South Africa.

BACKGROUND: Updated World Health Organization (WHO) treatment guidelines prioritize all-oral drug-resistant tuberculosis (DR-TB) regimens. Several poorly tolerated drugs, such as amikacin and para-aminosalicylic acid (PAS), remain treatment options for DR-TB in WHO-recommended longer regimens as Group C drugs. Incomplete treatment with anti-TB drugs increases the risk of treatment failure, relapse, and death. We determined whether missed doses of individual anti-TB drugs, and reasons for their discontinuation, varied in closely monitored hospital settings prior to the 2020 WHO DR-TB treatment guideline updates. METHODS: We collected retrospective data on adult patients with microbiologically confirmed DR-TB between 2008 and 2015 who were selected for a study of acquired drug resistance in the Western Cape Province of South Africa. Medical records through mid-2017 were reviewed. Patients received directly observed treatment during hospitalization at specialized DR-TB hospitals. Incomplete treatment with individual anti-TB drugs, defined as the failure to take medication as prescribed, regardless of reason, was determined by comparing percent missed doses, stratified by HIV status and DR-TB regimen. We applied a generalized mixed effects model. RESULTS: Among 242 patients, 131 (54%) were male, 97 (40%) were living with HIV, 175 (72%) received second-line treatment prior to first hospitalization, and 191 (79%) died during the study period. At initial hospitalization, 134 (55%) patients had Mycobacterium tuberculosis with resistance to rifampicin and isoniazid (multidrug-resistant TB [MDR-TB]) without resistance to ofloxacin or amikacin, and 102 (42%) had resistance to ofloxacin and/or amikacin. Most patients (129 [53%]) had multiple hospitalizations and DST changes occurred in 146 (60%) by the end of their last hospital discharge. Incomplete treatment was significantly higher for amikacin (18%), capreomycin (18%), PAS (17%) and kanamycin (16%) than other DR-TB drugs (P<0.001), including ethionamide (8%), moxifloxacin (7%), terizidone (7%), ethambutol (7%), and pyrazinamide (6%). Among the most frequently prescribed drugs, second-line injectables had the highest rates of discontinuation for adverse events (range 0.56-1.02 events per year follow-up), while amikacin, PAS and ethionamide had the highest rates of discontinuation for patient refusal (range 0.51-0.68 events per year follow-up). Missed doses did not differ according to HIV status or anti-TB drug combinations. CONCLUSION: We found that incomplete treatment for second-line injectables and PAS during hospitalization was higher than for other anti-TB drugs. To maximize treatment success, interventions to improve person-centered care and mitigate adverse events may be necessary in cases when PAS or amikacin (2020 WHO recommended Group C drugs) are needed.

Relationships Between Patient Race and Residential Race Context With Missed Human Immunodeficiency Virus Care Visits in the United States, 2010-2015.

BACKGROUND: Racial inequities exist in retention in human immunodeficiency virus (HIV) care and multilevel analyses are needed to contextualize and address these differences. Leveraging data from a multisite clinical cohort of people with HIV (PWH), we assessed the relationships between patient race and residential characteristics with missed HIV care visits. METHODS: Medical record and patient-reported outcome (PRO; including mental health and substance-use measures) data were drawn from 7 participating Center for AIDS Research Network of Integrated Clinical Systems (CNICS) sites including N = 20 807 PWH from January 2010 through December 2015. Generalized estimating equations were used to account for nesting within individuals and within census tracts in multivariable models assessing the relationship between race and missed HIV care visits, controlling for individual demographic and health characteristics and census tract characteristics. RESULTS: Black PWH resided in more disadvantaged census tracts, on average. Black PWH residing in census tracts with higher proportion of Black residents were more likely to miss an HIV care visit. Non-Black PWH were less likely to miss a visit regardless of where they lived. These relationships were attenuated when PRO data were included. CONCLUSIONS: Residential racial segregation and disadvantage may create inequities between Black PWH and non-Black PWH in retention in HIV care. Multilevel approaches are needed to retain PWH in HIV care, accounting for community, healthcare setting, and individual needs and resources.

Multiwave validation sampling for error-prone electronic health records.

Electronic health record (EHR) data are increasingly used for biomedical research, but these data have recognized data quality challenges. Data validation is necessary to use EHR data with confidence, but limited resources typically make complete data validation impossible. Using EHR data, we illustrate prospective, multiwave, two-phase validation sampling to estimate the association between maternal weight gain during pregnancy and the risks of her child developing obesity or asthma. The optimal validation sampling design depends on the unknown efficient influence functions of regression coefficients of interest. In the first wave of our multiwave validation design, we estimate the influence function using the unvalidated (phase 1) data to determine our validation sample; then in subsequent waves, we re-estimate the influence function using validated (phase 2) data and update our sampling. For efficiency, estimation combines obesity and asthma sampling frames while calibrating sampling weights using generalized raking. We validated 996 of 10,335 mother-child EHR dyads in six sampling waves. Estimated associations between childhood obesity/asthma and maternal weight gain, as well as other covariates, are compared to naïve estimates that only use unvalidated data. In some cases, estimates markedly differ, underscoring the importance of efficient validation sampling to obtain accurate estimates incorporating validated data.

Social Support and Breastfeeding Outcomes Among a Racially and Ethnically Diverse Population.

INTRODUCTION: Social support is a modifiable social determinant of health that shapes breastfeeding outcomes and may contribute to racial and ethnic breastfeeding disparities. This study characterizes the relationship between social support and early breastfeeding. METHODS: This is a cross-sectional analysis of baseline data collected in 2019-2021 for an RCT. Social support was measured using the Enhancing Recovery in Coronary Heart Disease Social Support Instrument. Outcomes, collected by self-report, included (1) early breastfeeding within the first 21 days of life, (2) planned breastfeeding duration, and (3) confidence in meeting breastfeeding goals. Each outcome was modeled using proportional odds regression, adjusting for covariates. Analysis was conducted in 2021-2022. RESULTS: Self-reported race and ethnicity among 883 mothers were 50% Hispanic, 17% Black, 23% White, and 10% other. A large proportion (88%) of mothers were breastfeeding. Most breastfeeding mothers (82%) planned to breastfeed for at least 6 months, with more than half (58%) planning to continue for 12 months or more. Most women (65%) were confident or very confident in meeting their breastfeeding duration goal. In adjusted models, perceived social support was associated with planned breastfeeding duration (p=0.042) but not with early breastfeeding (p=0.873) or confidence in meeting breastfeeding goals (p=0.427). Among the covariates, maternal depressive symptoms were associated with lower breastfeeding confidence (p<0.001). CONCLUSIONS: The associations between perceived social support and breastfeeding outcomes are nuanced. In this sample of racially and ethnically diverse mothers, social support was associated with longer planned breastfeeding duration but not with early breastfeeding or breastfeeding confidence.

High mortality among patients hospitalized for drug-resistant tuberculosis with acquired second-line drug resistance and high HIV prevalence.

OBJECTIVES: We compared mortality between HIV-positive and HIV-negative South African adults with drug-resistant tuberculosis (DR-TB) and high incidence of acquired second-line drug resistance. METHODS: We performed a retrospective review of DR-TB patients with serial second-line TB drug susceptibility tests (2008-2015) who were hospitalized at a specialized TB hospital. We used Kaplan-Meier analysis and Cox models to examine associations with mortality. RESULTS: Of 245 patients, the median age was 33 years, 54% were male and 40% were HIV-positive, 96% of whom had ever received antiretroviral therapy (ART). At initial drug resistance detection, 99% of patients had resistance to at least rifampicin and isoniazid, and 18% had second-line drug resistance (fluoroquinolones and/or injectable drugs). At later testing, 88% of patients had acquired additional second-line drug resistance. Patient-initiated treatment interruptions (> 2 months) occurred in 47%. Mortality was 79%. Those with HIV had a shorter time to death (p = 0.02; log-rank): median survival time from DR-TB treatment initiation was 2.44 years [95% confidence interval (CI): 2.09-3.15] versus 3.99 years (95% CI: 3.12-4.75) for HIV-negative patients. HIV-positive patients who received ART within 6 months before DR-TB treatment had a higher mortality hazard than HIV-negative patients [adjusted hazard ratio (aHR) ratio = 1.82, 95% CI: 1.21-2.74]. By contrast, HIV-positive patients who did not receive ART within 6 months before DR-TB treatment did not have a significantly higher mortality hazard than HIV-negative patients (aHR = 1.09; 95% CI: 0.72-1.65), although those on ART had lower median CD4 counts than those not on ART (157 vs. 281 cells/µL, respectively; p = 0.02). CONCLUSIONS: A very high incidence of acquired second-line drug resistance and high overall mortality were observed, reinforcing the need to reduce the risk of acquired resistance and for more effective treatment.

Tissue Sodium in Patients With Early Stage Hypertension: A Randomized Controlled Trial.

Background Sodium (Na+) stored in skin and muscle tissue is associated with essential hypertension. Sodium magnetic resonance imaging is a validated method of quantifying tissue stores of Na+. In this study, we evaluated tissue Na+ in patients with elevated blood pressure or stage I hypertension in response to diuretic therapy or low Na+ diet. Methods and Results In a double-blinded, placebo-controlled trial, patients with systolic blood pressure 120 to 139 mm Hg were randomized to low sodium diet (<2 g of sodium), chlorthalidone, spironolactone, or placebo for 8 weeks. Muscle and skin Na+ using sodium magnetic resonance imaging and pulse wave velocity were assessed at the beginning and end of the study. Ninety-eight patients were enrolled to undergo baseline measurements and 54 completed randomization. Median baseline muscle and skin Na+ in 98 patients were 16.4 mmol/L (14.9, 18.9) and 13.1 mmol/L (11.1, 16.1), respectively. After 8 weeks, muscle Na+ increased in the diet and chlorthalidone arms compared with placebo. Skin sodium was decreased only in the diet arm compared with placebo. These associations remained significant after adjustment for age, sex, body mass index, systolic blood pressure, and urinary sodium. No changes were observed in pulse wave velocity among the different groups when compared with placebo. Conclusions Diuretic therapy for 8 weeks did not decrease muscle or skin sodium or improve pulse wave velocity in patients with elevated blood pressure or stage I hypertension. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02236520.

Low Rates of Contraception Use in Women With Human Immunodeficiency Virus.

Background: Women with human immunodeficiency virus (WWH) have low rates of hormonal or long-acting contraceptive use. Few studies have described contraception use among WWH over time. Methods: We examined contraception (including all forms of hormonal contraception, intrauterine devices, and bilateral tubal ligations) use among cisgender women aged 18-45 years in care at Vanderbilt's human immunodeficiency virus (HIV) clinic in Nashville, Tennessee, from 1998 through 2018. Weighted annual prevalence estimates of contraception use were described. Cox proportional hazards models examined factors associated with incident contraception use and pregnancy. Results: Of the 737 women included, median age at clinic entry was 31 years; average follow-up was 4.1 years. At clinic entry, 47 (6%) women were on contraception and 164 (22%) were pregnant. The median annual percentage of time on any contraception use among nonpregnant women was 31.7% and remained stable throughout the study period. Younger age was associated with increased risk of pregnancy and contraceptive use. Psychiatric comorbidity decreased likelihood of contraception (adjusted hazard ratio [aHR], 0.52 [95% CI {confidence interval}, .29-.93]) and increased likelihood of pregnancy (aHR, 1.77 [95% CI, .97-3.25]). While not associated with contraceptive use, more recent year of clinic entry was associated with higher pregnancy risk. Race, substance use, CD4 cell count, HIV RNA, smoking, and antiretroviral therapy were not associated with contraception use nor pregnancy. Conclusions: Most WWH did not use contraception at baseline nor during follow-up. Likelihood of pregnancy increased with recent clinic entry while contraception use remained stable over time. Continued efforts to ensure access to effective contraception options are needed in HIV clinics.

CD4/CD8 Ratio and Cancer Risk Among Adults With HIV.

BACKGROUND: Independent of CD4 cell count, a low CD4/CD8 ratio in people with HIV (PWH) is associated with deleterious immune senescence, activation, and inflammation, which may contribute to carcinogenesis and excess cancer risk. We examined whether low CD4/CD8 ratios predicted cancer among PWH in the United States and Canada. METHODS: We examined all cancer-free PWH with 1 or more CD4/CD8 values from North American AIDS Cohort Collaboration on Research and Design observational cohorts with validated cancer diagnoses between 1998 and 2016. We evaluated the association between time-lagged CD4/CD8 ratio and risk of specific cancers in multivariable, time-updated Cox proportional hazard models using restricted cubic spines. Models were adjusted for age, sex, race and ethnicity, hepatitis C virus, and time-updated CD4 cell count, HIV RNA, and history of AIDS-defining illness. RESULTS: Among 83 893 PWH, there were 5628 incident cancers, including lung cancer (n = 755), Kaposi sarcoma (n = 501), non-Hodgkin lymphoma (n = 497), and anal cancer (n = 439). The median age at cohort entry was 43 years. The overall median 6-month lagged CD4/CD8 ratio was 0.52 (interquartile range = 0.30-0.82). Compared with a 6-month lagged CD4/CD8 of 0.80, a CD4/CD8 of 0.30 was associated with increased risk of any incident cancer (adjusted hazard ratio = 1.24 [95% confidence interval = 1.14 to 1.35]). The CD4/CD8 ratio was also inversely associated with non-Hodgkin lymphoma, Kaposi sarcoma, lung cancer, anal cancer, and colorectal cancer in adjusted analyses (all 2-sided P < .05). Results were similar using 12-, 18-, and 24-month lagged CD4/CD8 values. CONCLUSIONS: A low CD4/CD8 ratio up to 24 months before cancer diagnosis was independently associated with increased cancer risk in PWH and may serve as a clinical biomarker.

Development and Validation of a Multivariable Prediction Model for Missed HIV Health Care Provider Visits in a Large US Clinical Cohort.

BACKGROUND: Identifying individuals at high risk of missing HIV care provider visits could support proactive intervention. Previous prediction models for missed visits have not incorporated data beyond the individual level. METHODS: We developed prediction models for missed visits among people with HIV (PWH) with ≥1 follow-up visit in the Center for AIDS Research Network of Integrated Clinical Systems from 2010 to 2016. Individual-level (medical record data and patient-reported outcomes), community-level (American Community Survey), HIV care site-level (standardized clinic leadership survey), and structural-level (HIV criminalization laws, Medicaid expansion, and state AIDS Drug Assistance Program budget) predictors were included. Models were developed using random forests with 10-fold cross-validation; candidate models with the highest area under the curve (AUC) were identified. RESULTS: Data from 382 432 visits among 20 807 PWH followed for a median of 3.8 years were included; the median age was 44 years, 81% were male, 37% were Black, 15% reported injection drug use, and 57% reported male-to-male sexual contact. The highest AUC was 0.76, and the strongest predictors were at the individual level (prior visit adherence, age, CD4+ count) and community level (proportion living in poverty, unemployed, and of Black race). A simplified model, including readily accessible variables available in a web-based calculator, had a slightly lower AUC of .700. CONCLUSIONS: Prediction models validated using multilevel data had a similar AUC to previous models developed using only individual-level data. The strongest predictors were individual-level variables, particularly prior visit adherence, though community-level variables were also predictive. Absent additional data, PWH with previous missed visits should be prioritized by interventions to improve visit adherence.

A Health-Literacy Intervention for Early Childhood Obesity Prevention: A Cluster-Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Children who become overweight by age 2 have greater risk of long-term obesity and health problems. The study aim was to assess the effectiveness of a primary care-based intervention on the prevalence of overweight at age 24 months. METHODS: In a cluster-randomized trial, sites were randomly assigned to the Greenlight intervention or an attention-control arm. Across 4 pediatric residency clinics, we enrolled infant-caregiver dyads at the 2-month well-child visit. Inclusion criteria included parent English- or Spanish-speaking and birth weight ≥1500 g. Designed with health-literacy principles, the intervention included a parent toolkit at each well-child visit, augmented by provider training in clear-health communication. The primary outcome was proportion of children overweight (BMI ≥85th percentile) at age 24 months. Secondary outcomes included weight status (BMI z score). RESULTS: A total of 459 intervention and 406 control dyads were enrolled. In total, 49% of all children were overweight at 24 months. Adjusted odds for overweight at 24 months (treatment versus control) was 1.02 (95% confidence interval [CI]: 0.63 to 1.64). Adjusted mean BMI z score differences (treatment minus control) were -0.04 (95% CI: -0.07 to -0.01), -0.09 (95% CI: -0.14 to -0.03), -0.19 (-0.33 to -0.05), -0.20 (-0.36 to -0.03), -0.16 (95% CI: -0.34 to 0.01), and 0.00 (95% CI -0.21 to 0.21) at 4, 6, 12, 15, 18, and 24 months, respectively. CONCLUSIONS: The intervention resulted in less weight gain through age 18 months, which was not sustained through 24 months. Clinic-based interventions may be beneficial for early weight gain, but greater intervention intensity may be needed to maintain positive effects.

Risk of Incident Diabetes Mellitus, Weight Gain, and Their Relationships With Integrase Inhibitor-Based Initial Antiretroviral Therapy Among Persons With Human Immunodeficiency Virus in the United States and Canada.

BACKGROUND: Integrase strand transfer inhibitor (INSTI)-based combination antiretroviral therapy (cART) is associated with greater weight gain among persons with human immunodeficiency virus (HIV), though metabolic consequences, such as diabetes mellitus (DM), are unclear. We examined the impact of initial cART regimen and weight on incident DM in a large North American HIV cohort (NA-ACCORD). METHODS: cART-naive adults (≥18 years) initiating INSTI-, protease inhibitor (PI)-, or nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimens from January 2007 through December 2017 who had weight measured 12 (±6) months after treatment initiation contributed time until clinical DM, virologic failure, cART regimen switch, administrative close, death, or loss to follow-up. Multivariable Cox regression yielded adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for incident DM by cART class. Mediation analyses, with 12-month weight as mediator, similarly adjusted for all covariates. RESULTS: Among 22 884 eligible individuals, 47% started NNRTI-, 30% PI-, and 23% INSTI-based cART with median follow-up of 3.0, 2.3, and 1.6 years, respectively. Overall, 722 (3%) developed DM. Persons starting INSTIs vs NNRTIs had incident DM risk (HR, 1.17 [95% CI, .92-1.48]), similar to PI vs NNRTI initiators (HR, 1.27 [95% CI, 1.07-1.51]). This effect was most pronounced for raltegravir (HR, 1.42 [95% CI, 1.06-1.91]) vs NNRTI initiators. The INSTI-DM association was attenuated (HR, 1.03 [95% CI, .71-1.49] vs NNRTIs) when accounting for 12-month weight. CONCLUSIONS: Initiating first cART regimens with INSTIs or PIs vs NNRTIs may confer greater risk of DM, likely mediated through weight gain.

Infant Television Watching Predicts Toddler Television Watching in a Low-Income Population.

OBJECTIVE: This study examines the development of active television (TV) watching behaviors across the first 2 years of life in a racially and ethnically diverse, low-income cohort and identifies caregiver and child predictors of early TV watching. METHODS: We used longitudinal data from infants enrolled in the active control group (N = 235; 39% Latino; 29% Black; 15% White) of Greenlight, a cluster randomized multisite trial to prevent childhood obesity. At preventive health visits from 2 months to 2 years, caregivers were asked: "How much time does [child's first name] spend watching television each day?" Proportional odds models and linear regression analyses were used to assess associations among TV introduction age, active TV watching amount at 2 years, and sociodemographic factors. RESULTS: Sixty-eight percent of children watched TV by 6 months, and 88% by 2 years. Age of TV introduction predicted amount of daily active TV watching at 2 years, with a mean time of 93 minutes if starting at 2 months; 64 minutes if starting at 4 or 6 months; and 42 minutes if starting after 6 months. Factors predicting earlier introduction included lower income, fewer children in household, care away from home, male sex, and non-Latino ethnicity of child. CONCLUSIONS: Many caregivers report that their infants actively watch TV in the first 6 months of life. Earlier TV watching is related to sociodemographic factors yet predicts more daily TV watching at 2 years even controlling those factors. Interventions to limit early TV watching should be initiated in infancy.

A Description of Risk Factors for Non-alcoholic Fatty Liver Disease in the Southern Community Cohort Study: A Nested Case-Control Study.

Background: Non-alcoholic fatty liver disease (NAFLD) is associated with obesity and hypercholesterolemia. In addition, total fat and folate intake have been associated with NAFLD. Aims: We investigated risk factors for NAFLD among individuals of largely low socioeconomic status, and whether these associations differed by race. Methods: A nested case-control study was conducted within the Southern Community Cohort Study. Through linkage of the cohort with Centers for Medicare and Medicaid Services, International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to identify incident NAFLD cases. Controls were matched 4:1 to cases on enrollment age, sex, and race. A logistic regression was used to estimate odds ratios for the associations of NAFLD with covariates of interest. Results: Neither total fat nor folate intake was significantly associated with NAFLD. Hypercholesterolemia (odds ratio 1.21) and body mass index (75th vs. 25th percentile) for blacks (odds ratio 1.96) and whites (odds ratio 2.33) were associated with an increased risk of non-alcoholic fatty liver disease. No significant interaction with race for any of the studied variables was noted. Conclusions: Both hypercholesterolemia and increasing body mass index, but not total fat and folate intake, were risk factors for NAFLD in the Southern Community Cohort Study.

Nephrology Provider Surprise Question Response and Hospitalizations in Older Adults with Advanced CKD.

BACKGROUND: Older adults with advanced non-dialysis-dependent chronic kidney disease (NDD-CKD) face a high risk of hospitalization and related adverse events. METHODS: This prospective cohort study followed nephrology clinic patients ≥60 years old with NDD-CKD stages 4-5. After an eligible patient's office visit, study staff asked the patient's provider to rate the patient's risk of death within the next year using the surprise question ("Would you be surprised if this patient died in the next 12 months?") with a 5-point Likert scale response (1, "definitely not surprised" to 5, "very surprised"). We used a statewide database to ascertain hospitalization during follow-up. RESULTS: There were 488 patients (median age 72 years, 51% female, 17% black) with median estimated glomerular filtration rate 22 mL/min/1.73 m2. Over a median follow-up of 2.1 years, the rates of hospitalization per 100 person-years in the respective response groups were 41 (95% confidence interval [CI]: 34-50), "very surprised"; 65 (95% CI: 55-76), "surprised"; 98 (95% CI: 85-113), "neutral"; 125 (95% CI: 107-144), "not surprised"; and 120 (95% CI: 94-151), "definitely not surprised." In a fully adjusted cumulative probability ordinal regression model for proportion of follow-up time spent hospitalized, patients whose providers indicated that they would be "definitely not surprised" if they died spent a greater proportion of follow-up time hospitalized compared with those whose providers indicated that they would be "very surprised" (odds ratio 2.4, 95% CI: 1.0-5.7). There was a similar association for time to first hospitalization. CONCLUSION: Nephrology providers' responses to the surprise question for older patients with advanced NDD-CKD were independently associated with proportion of future time spent hospitalized and time to first hospitalization. Additional studies should examine how to use this information to provide patients with anticipatory guidance on their possible clinical trajectory and to target potentially preventable hospitalizations.