Ian M Paul

• MD
• University Professor at Penn State Hershey Medical Center and Penn State College of Medicine

Importance Behavioral interventions to treat childhood obesity have had limited success. Primary prevention is desirable, but whether intervention effectiveness can be sustained is unknown. Objective To examine the effect of an intervention designed for the primary prevention of obesity and delivered through age 2 years on weight outcomes through...

Background Early childhood obesity prevention interventions that aim to change parent/caregiver practices related to infant (milk) feeding, food provision and parent feeding, movement (including activity, sedentary behaviour) and/or sleep health (i.e. target parental behaviour domains) are diverse and heterogeneously reported. We aimed to 1) system...

Objective Suboptimal sleep is associated with disruptive behaviors in childhood. We evaluate associations of mean and variability (SD) of sleep duration, quality, and timing with emotion regulation, impulsivity, and prosocial and antisocial behavior in children. Methods Intervention Nurses Start Infants Growing on Healthy Trajectories, a randomize...

Self-regulation encompasses the ability to modulate behavior, cognition, and emotions. Parents can promote child self-regulation with responsive parenting (RP). RP shapes various components of self-regulation and is associated with numerous developmental outcomes. Here, we examine long-term effects of an early-life RP intervention designed for obes...

Background: Maternal pre-pregnancy body mass index (BMI) is positively associated with offspring overweight. We investigated behaviors that may confer resilience to childhood overweight development by examining appetitive traits in at-risk children born to mothers with pre-pregnancy overweight. Methods: This secondary analysis included children bor...

Childhood obesity represents a significant global health concern and identifying its risk factors is crucial for developing intervention programs. Many “omics” factors associated with the risk of developing obesity have been identified, including genomic, microbiomic, and epigenomic factors. Here, using a sample of 48 infants, we investigated how t...

Childhood obesity represents a significant global health concern and identifying risk factors is crucial for developing intervention programs. Many "omics" factors associated with the risk of developing obesity have been identified, including genomic, microbiomic, and epigenomic factors. Here, using a sample of 48 infants, we investigated how the m...

Objective: The aim of this study was to examine the effect of a responsive parenting (RP) intervention on toddler diet and explore associations with mothers' infant feeding practices and child weight status. Methods: INSIGHT tested an RP intervention designed for the prevention of obesity against a safety control among primiparous mothers and th...

Objective: A 2015 survey of primary care providers (PCPs) found that while many believed that milliliter (mL)-only dosing was safest for oral liquid medications, few would use mL alone in dosing instructions. Since 2015, many recommendations have promoted "mL-only" dosing. In 2019, a follow-up survey was conducted to assess if PCP perceptions and...

Introduction Poor sleep health is associated with increased risk for childhood obesity, but the underlying mechanisms are unclear. Eating behaviors may play a role. We examined the association between appetitive traits and objectively-measured sleep variables in 6-year-old children. We hypothesized that poorer or more variable sleep health measures...

Introduction The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention for first-time mothers resulted in more responsive bedtime parenting and longer infant sleep duration in the first year after birth. The current analysis evaluates intervention effects on parent-reported sleep behavior...

In the context of the childhood obesity epidemic, this narrative review aims to explore opportunities to promote physical activity (PA) between birth and age 5 years as well as the health outcomes associated with PA in early childhood. Although early childhood is an ideal time to promote healthy habits, guidelines for PA have often ignored early ch...

Background Internalized weight bias (IWB) refers to an individual's belief in negative weight‐related stigma. Children and adolescents are particularly vulnerable to IWB, but little is known about IWB in this population. Objective To conduct a systematic review to (1) identify the instruments that measure IWB among children and adolescents and (2)...

Unlabelled: To reduce gastroesophageal reflux, infants are commonly placed in an inclined position. We sought to observe the extent to which infants exhibit (1) oxygen desaturation and bradycardia in supine and inclined positions and (2) signs and symptoms of post-feed regurgitation in these positions. Study design: Healthy infants aged 1-5 mont...

Objective To compare the proportion of female and male fetuses classified as microcephalic (head circumference [HC] < 3rd percentile) and macrocephalic (>97th percentile) by commonly used sex-neutral growth curves.Methods For fetuses evaluated at a single center, we retrospectively determined the percentile of the first fetal HC measurement between...

Background: Rapid weight gain during infancy is associated with risk for later obesity, yet little research to date has examined the effect of a responsive parenting (RP) intervention with care coordination between pediatric primary care providers and Women, Infants, and Children nutritionists on infant weight. Methods: The Women, Infants, and Chil...

Objectives To examine effects of the INSIGHT studyresponsive parenting (RP) intervention on reported and observed general parenting and child behavior during early and middle childhood. Study design Primiparous mother-newborn dyads (n=279) were randomized to RP intervention or a safety control, with intervention content delivered at research nurse...

BACKGROUND AND OBJECTIVES The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention for first-time mothers improved firstborn infant sleep compared with controls. The goals of this analysis were to test intervention spillover effects on secondborn siblings and examine birth order differen...

BACKGROUND AND OBJECTIVE The Newborn Weight Tool (NEWT) can inform newborn feeding decisions and might reduce health care utilization by preventing excess weight loss. Clinical decision support (CDS) displaying NEWT might facilitate its use. Our study’s objective is to determine the effect of CDS displaying NEWT on feeding and health care utilizati...

The Millennial Generation, also known as Generation Y, is the demographic cohort following Generation X, and is generally regarded to be composed of those individuals born between 1980 and 2000. They are the first to grow up in an environment where health-related information is widely available by internet, TV and other electronic media, yet we kno...

Background Firstborn children are more likely to have obesity than secondborns, which may partially be explained by differential use of food to soothe (FTS) infant distress, which has been inked to higher weight status. Objectives To test associations between the birth order and maternal FTS and whether differences in sibling temperament and body...

Introduction Little is known about how early (eg, commencing antenatally or in the first 12 months after birth) obesity prevention interventions seek to change behaviour and which components are or are not effective. This study aims to (1) characterise early obesity prevention interventions in terms of target behaviours, delivery features and behav...

Introduction: Behavioural interventions in early life appear to show some effect in reducing childhood overweight and obesity. However, uncertainty remains regarding their overall effectiveness, and whether effectiveness differs among key subgroups. These evidence gaps have prompted an increase in very early childhood obesity prevention trials wor...

Objective The aim of this study was to test whether the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) responsive parenting (RP) intervention, delivered to parents of firstborn children, is associated with the BMI of first- and second-born siblings during infancy. Methods Participants included 117 firstborn infants enr...

Medication administration errors that take place in the home are common, especially when liquid preparations are used and complex medication schedules with multiple medications are involved; children with chronic conditions are disproportionately affected. Parents and other caregivers with low health literacy and/or limited English proficiency are...

Obesity is a highly heritable condition that affects increasing numbers of adults and, concerningly, of children. However, only a small fraction of its heritability has been attributed to specific genetic variants. These variants are traditionally ascertained from genome-wide association studies (GWAS), which utilize samples with tens or hundreds o...

Background and objectives: In 2008, over-the-counter cough and cold medications (CCMs) underwent labeling changes in response to safety concerns, including fatalities, reported in children exposed to CCMs. The objective of this study is to describe fatalities associated with exposures to CCMs in children <12 years old that were detected by a safet...

Background Metabolomic analysis is commonly used to understand the biological underpinning of diseases such as obesity. However, our knowledge of gut metabolites related to weight outcomes in young children is currently limited. Objectives To (1) explore the relationships between metabolites and child weight outcomes, (2) determine the potential e...

Studies from diverse cultures report mixed results in the relationship between birth order and risk for obesity. Explanations may thus lie in the postnatal period when growth is shaped by the family environment, including parental feeding practices, which may be affected by siblings. Consistent with a family systems perspective, we describe two pro...

Background: INSIGHT tested an early life responsive parenting (RP) intervention designed for obesity prevention. BMIz at age 3 years was lower for the RP group versus controls with a larger effect for girls than boys. We sought to determine if child sex was associated with differing maternal feeding practices and whether sex moderated intervention...

Abstract Objective A narrative review of randomized, blinded, controlled studies assessing the antipyretic effect of ibuprofen versus acetaminophen or combined or alternating treatment in children was conducted. Methods Searches of the PubMed and Embase literature databases were conducted to identify relevant articles. Selected articles were limit...

Background and objectives: The Best Pharmaceuticals for Children Act (BPCA) incentivizes the study of on-patent medicines in children and mandates that the National Institutes of Health sponsor research on off-patent drugs important to pediatric therapeutics. Failing to enroll cohorts that reflect the pediatric population at large restricts the ge...

Expert guidance encourages interventions promoting structure-based practices to establish predictable eating environments in order to foster children's self-regulatory skills. However, few studies have examined whether and how child characteristics may moderate effects of interventions on maternal feeding practices. This analysis aimed to examine t...

Women with excessive gestational weight gain (GWG) are at risk for poor psychoso-cial well-being and postpartum weight retention (PPWR). Scant research has examined longitudinal interrelations of GWG, psychosocial factors, and PPWR. This study examined: (a) pre-pregnancy weight status (ie, normal, overweight, obesity) differences in PPWR and its ps...

Newborns with neonatal abstinence syndrome (NAS) display symptoms related to neurologic excitability and autonomic dysfunction that result in increased metabolic demands. These infants also exhibit feeding difficulties and/or hyperphagia. Because the effects of these symptoms and behaviors on growth are unknown, we sought to measure serial body com...

Background/aims: When conducting clinical trials comparing over-the-counter (OTC) medications, the wide availability of these treatments are a potential challenge to maintaining study integrity. We seek to describe adherence to a study protocol involving widely available OTC medications. Methods: To prospectively evaluate associations between ac...

Rapid infant growth increases the risk for adult obesity. The gut microbiome is associated with early weight status; however, no study has examined how interactions between microbial and host ribonucleic acid (RNA) expression influence infant growth. We hypothesized that dynamics in infant stool micro-ribonucleic acids (miRNAs) would be associated...

Introduction Behavioural interventions in early life appear to show some effect in reducing childhood overweight and obesity. However, uncertainty remains regarding their overall effectiveness, and whether effectiveness differs among key subgroups. These evidence gaps have prompted an increase in very early childhood obesity prevention trials world...

Introduction Little is known about how early (e.g., commencing antenatally or in the first 12 months after birth) obesity prevention interventions seek to change behaviour and which components are or are not effective. This study aims to 1) characterise early obesity prevention interventions in terms of target behaviours, delivery features, and beh...

Background Socioeconomically disadvantaged newborns receive care from primary care providers (PCPs) and Women, Infants, and Children (WIC) nutritionists. However, care is not coordinated between these settings, which can result in conflicting messages. Stakeholders support an integrated approach that coordinates services between settings with care...

An amendment to this paper has been published and can be accessed via the original article.

Background: With increased use of telehealth, interventions to improve infant sleep environments have not been explored. This study sought to assess the feasibility and efficacy of using electronic health record patient portals to transmit photographs of infant sleep between mothers and healthcare professionals as part of an intervention to promot...

Introduction: Initial research following regulatory changes addressing the pediatric safety of cough and cold medications (CCMs) demonstrated decreases in adverse events (AEs). Using a national multi-source surveillance system, we studied subsequent CCM-related AE case rate trends and associated health-care facility (HCF) evaluation in children....

BACKGROUND Socioeconomically-disadvantaged newborns receive care from primary-ambulatory-care providers (PCPs) and Women, Infant and Children (WIC) Nutritionists; however, care is not coordinated between these settings, which can result in conflicting messages. Previous studies have shown these stakeholders support an integrated approach that coord...

Objective Women with elevated body mass index are encouraged to lose weight before pregnancy, but no trials have tested the effects of pre-pregnancy weight loss on health outcomes. Our objective was to determine whether pre-pregnancy weight loss reduces gestational weight gain and improves pregnancy outcomes. Study Design Pragmatic randomized clin...

Objectives: Previous research has demonstrated that accidental unsupervised ingestions (AUIs) were responsible for the majority of cough and cold medication (CCM) ingestions leading to significant adverse events (AEs) in children. The objective of this analysis was to characterize the role of AUIs in the morbidity associated with CCM exposure in c...

On 26 May, 2019, the nutrition community lost a visionary ambassador, trusted advisor, and cherished mentor. Leann Birch was a pioneer in bringing a developmental psychology perspective to the study of children's nutrition as a means to respond to real-world questions raised by parents. Leann Elsie Traub was born in Owosso, Michigan 25 June, 1946....

Biography of Leann L. Birch, PhD

Background: Although previous work has shown that children with older siblings tend to have poorer diet quality, no study has directly compared diets of infant siblings. Objective: The goals of this analysis were to examine birth-order differences in dietary intake between firstborn (FB) and secondborn (SB) siblings, and to determine whether a r...

Background Although sleep duration is a risk factor for obesity in young children, less is known about other aspects of sleep health, including bedtime, on obesity risk. Objective To determine whether bedtime is associated with body mass index (BMI) z‐score or obesity risk in children ages 2 to 5 years, and to determine if associations are indepen...

Background Child emotional overeating is a risk factor for obesity that is learned in the home environment. Parents' use of food to soothe child distress may contribute to the development of children's emotional overeating. Objectives To examine the effect of a responsive parenting (RP) intervention on mother‐reported child emotional overeating, a...

Importance More than 20% of births globally are by cesarean delivery, including more than 30% in the US. Prior studies have reported lower rates of childbearing after cesarean delivery, but it is not clear if this is due to maternal choice or lower conception rates. Objective To investigate the association between mode of first delivery and subseq...

Background: Weight is critical for the medical management of infants; however, scales can be unavailable or inaccessible in some practice settings. We recently developed and validated a robust infant weight estimation method based on chest circumference (CC) and head circumference (HC). This study was designed to determine the human factors (HF) e...

Heteroplasmy is the presence of variable mitochondrial DNA (mtDNA) within the same individual. The dynamics of heteroplasmy allele frequency among tissues of the human body is not well understood. Here, we measured allele frequency at heteroplasmic sites in two to eight hairs from each of 11 humans using next-generation sequencing. We observed a hi...

Background: The Intervention Nurses Start Infant Growing on Healthy Trajectories (INSIGHT) study's responsive parenting (RP) intervention, initiated in early infancy, prevented the use of nonresponsive, controlling feeding practices and promoted use of structure-based feeding among first-time parents compared with controls. Objectives: We sought...

Heteroplasmy—the presence of multiple mitochondrial DNA (mtDNA) haplotypes in an individual—can lead to numerous mitochondrial diseases. The presentation of such diseases depends on the frequency of the heteroplasmic variant in tissues, which, in turn, depends on the dynamics of mtDNA transmissions during germline and somatic development. Thus, und...

Abstract Background Use of food to soothe infant distress has been linked to greater weight in observational studies. We used ecological momentary assessment to capture detailed patterns of food to soothe and evaluate if a responsive parenting intervention reduced parents’ use of food to soothe. Methods Primiparous mother-newborn dyads were randomi...

Objective: Out of hospital medication-related adverse events (AEs) from cough and cold medications (CCMs) can have significant public health impact. The objective of this study was to characterize pediatric medication error AEs involving over-the-counter (OTC) CCMs to identify preventable factors. Methods: Multi-source national data surveillance...

Importance Breastfeeding through 6 and 12 months are 2 goals of the Centers for Disease Control and Prevention Healthy People 2020 initiative, but the 6-month goal is met for only 52% of US infants and the 12-month goal for 30% of US infants. Objective To determine whether structured, short-term formula supplementation for at-risk neonates affects...

Objectives: To explore the discordance of maternal feeding practices by birth order and weight status between FBs participating in the Intervention Nurses Start Infants Growing on Health Trajectories (INSIGHT) trial and their secondborn (SB) siblings. Methods: Structure and control-based parent feeding practices were assessed at 1 year in FBs an...

Introduction: Diphenhydramine (DPH) exposures in children may be the result of accidental unsupervised ingestions, caregiver error, and intentional misuse of DPH-containing cough and cold medications (CCM). We sought to understand the nature of pediatric ingestions of DPH, particularly the toxicity and outcome of a single product, single ingredient...

Obesity is highly heritable, yet only a small fraction of its heritability has been attributed to specific genetic variants. These variants are traditionally ascertained from genome-wide association studies (GWAS), which utilize samples with tens or hundreds of thousands of individuals for whom a single summary measurement (e.g., BMI) is collected....

Introduction: Flow restrictors are child-resistant packaging innovations designed to limit the amount of liquid dispensed from a medication bottle. In 2011, flow restrictors were added to pediatric liquid single-ingredient acetaminophen formulations. The hypothesis of this study is that implementation would be associated with reduced volume and se...

Responsive parenting is a promising framework for obesity prevention, yet attempts to date have largely relied on parents accurately interpreting their child's cues. Infant signing or “baby sign language” could enhance these interventions by improving bidirectional parent‐child communication during the preverbal and emerging language years. In a cl...

Background The purpose of this report is to evaluate the quality of data sources used to study cough and cold medication (CCM) safety in children via the Pediatric Cough and Cold Safety Surveillance System. Methods The System utilized the National Poison Data System (NPDS), FDA Adverse Event Reporting System (FAERS), English-language medical liter...

Introduction: Factors that occur between consecutive pregnancies may influence repeated excessive gestational weight gain (GWG) and infants born large-for-gestational age (LGA). We examined interpregnancy interval, weight retention, and GWG in women's first pregnancy as predictors of excessive GWG and LGA in women's second pregnancy. Methods: We...

Background Infants with neonatal abstinence syndrome (NAS) initially experience neurologic excitability, poor feeding, and/or hyperphagia in the setting of increased metabolic demand. Because the longitudinal effects of these early symptoms and behaviors on weight trends are unknown, we sought to contrast weight gain patterns through age 1 year for...

Figure S1. Visual predictive check results stratified by age from final population PK model. Figure S2. Histograms of age and weight of the subjects use in dosing simulations.

Table S1. Covariate model‐testing process.

Code S1. NONMEM code for final population PK model describing diazepam in children with SE.

Supplementary Information S1. PK sample collection and bioanalytical assay methods description.

Despite the known benefits of breastmilk, associations between breastfeeding and child overall health outcomes remain unclear. We aimed to understand associations between breastfeeding and health outcomes, including child weight, through age 3. Analysis included women (N = 3006) in the longitudinal, prospective First Baby Study from 2009 to 2014. F...

Gut and oral microbiota perturbations have been observed in obese adults and adolescents; less is known about their influence on weight gain in young children. Here we analyzed the gut and oral microbiota of 226 two-year-olds with 16S rRNA gene sequencing. Weight and length were measured at seven time points and used to identify children with rapid...

Background: Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information techn...

Background In recent years, there has been increasing recognition of the importance of early maternal‐newborn contact for the health and well‐being of the newborn and promotion of breastfeeding. However, little research has investigated the association between early maternal‐newborn contact and the mother's birth experience. Methods As part of a l...

Objective: Maternal return to work within 12 weeks of delivery is associated with poor child health and development. However, little is known about the impact of return to work on child obesity risk. We examined whether timing of maternal return to work is associated with rapid infant weight gain from 0-6 months and weight-for-length at 1 year. M...

Background: What, when, how, how much, and how often infants are fed have been associated with childhood obesity risk. The objective of this secondary analysis was to examine the effect of a responsive parenting (RP) intervention designed for obesity prevention on parents' infant feeding practices in the first year after birth. Methods: Primipar...

Importance Rapid growth and elevated weight status in early childhood increase risk for later obesity, but interventions that improve growth trajectories are lacking. Objective To examine effects of a responsive parenting intervention designed to promote developmentally appropriate, prompt, and contingent responses to a child’s needs on weight out...

Objective: Infants higher on negative reactivity and lower on regulation, aspects of temperament, have increased obesity risk. Responsive parenting (RP) has been shown to impact the expression of temperament, including the developing ability to regulate negative emotions. The aim of this analysis was to test the effects of the INSIGHT study's RP i...

Background: Until recently most of the scrutiny of opioid-containing cough and cold medications (CCMs) by the US Food and Drug Administration (FDA) was focused on codeine, only recently shifting equal focus to those containing hydrocodone. We characterized adverse events (AEs) in children <12 years old associated with CCMs that include both an opio...

Objective: To examine the impact from Family Foundations, a transition-to-parenting intervention, on parent and child outcomes 2 years after birth. Background: Couples transitioning to parenthood face many stressors and challenges that are not typically addressed through commonly available childbirth preparatory classes. The Family Foundations p...

Abstract Background Sedentary behaviors, including screen time, in childhood have been associated with an increased risk for overweight. Beginning in infancy, we sought to reduce screen time and television exposure and increase time spent in interactive play as one component of a responsive parenting (RP) intervention designed for obesity preventio...

Retrospective studies have demonstrated associations between acetaminophen and exacerbations in asthma, purportedly due to reductions in the antioxidant, glutathione. In this study of young children with mild asthma treated with acetaminophen, baseline levels of glutathione were not associated with future exacerbations.

Objective: To determine whether using 10 mL formula after each breastfeeding before copious maternal milk production affects breastfeeding duration, readmission, and intestinal microbiota through 1 month of age. Study design: In this randomized controlled trial, we enrolled 164 exclusively breastfeeding newborns, 24-72 hours old, whose weight lo...

New care delivery models call for integrating health services to coordinate care and improve patient-centeredness. Such models have been embraced to coordinate care with evidence-based strategies to prevent obesity. Both the Special Supplemental Program for Women, Infants and Children (WIC) Program and pediatricians are considered credible sources...

Weight is the foremost marker of health outcomes in infants; however, the majority of community workers and health care providers in remote, resource-constrained settings have limited access to functional scales. This study develops and validates a simple weight estimation strategy for infants that addresses the limitations of current approaches. C...

Objective: Guidelines recommend closer outpatient follow-up for exclusively breastfed newborns, especially those with pronounced weight loss, because of increased risk of hyperbilirubinemia and dehydration that might require readmission. Our objective was to determine how feeding method and weight loss are associated with neonatal healthcare utili...