Every sip counts: Understanding hydration behaviors and user-acceptability of digital tools to promote adequate intake during early and late pregnancy.

Maintaining adequate hydration over the course of pregnancy is critical for maternal and fetal health and reducing risks for adverse pregnancy outcomes (e.g., preeclampsia, low placental and amniotic fluid volume). Recent evidence suggests that women may be at risk for under-hydration in the second and third trimesters when water needs begin to increase. Scant research has examined pregnant women's knowledge of hydration recommendations, water intake behaviors, and willingness to use digital tools to promote water intake. This study aimed to: 1) describe hydration recommendation knowledge and behaviors by the overall sample and early vs late pregnancy, and 2) identify habits and barriers of using digital tools. Pregnant women (N = 137; M age = 30.9 years; M gestational age = 20.9) completed a one-time, 45-minute online survey. Descriptive statistics quantified women's knowledge of hydration recommendations, behaviors, and attitudes about utilizing digital tools to promote adequate intake, and Mann-Whitney U and chi-squared tests were used to determine group differences. Most women lacked knowledge of and were not meeting hydration recommendations (63%, 67%, respectively) and were not tracking their fluid consumption (59%). Knowledge of hydration recommendations differed by time of pregnancy, such that women in later pregnancy reported 82 ounces compared to women in early pregnancy (49 ounces). Common barriers included: forgetting to drink (47%), not feeling thirsty (47%), and increased urination (33%). Most were willing to use digital tools (69%) and believed a smart water bottle would help them achieve daily fluid recommendations (67%). These initial findings suggest that pregnant women may benefit from useful strategies to increase knowledge, decrease barriers, and maintain adequate hydration, specifically earlier in pregnancy. These findings will inform the design of a behavioral intervention incorporating smart connected water bottles, wearables for gesture detection, and behavior modification strategies to overcome barriers, promote proper hydration and examine its impact on maternal and infant health outcomes.

Methylation profiles at birth linked to early childhood obesity.

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 the methylation profiles in cord blood and placenta at birth were associated with weight outcomes (specifically, conditional weight gain, body mass index, and weight-for-length ratio) at age six months. We characterized genome-wide DNA methylation profiles using the Illumina Infinium MethylationEpic chip, and incorporated information on child and maternal health, and various environmental factors into the analysis. We used regression analysis to identify genes with methylation profiles most predictive of infant weight outcomes, finding a total of 23 relevant genes in cord blood and 10 in placenta. Notably, in cord blood, the methylation profiles of three genes (PLIN4, UBE2F, and PPP1R16B) were associated with all three weight outcomes, which are also associated with weight outcomes in an independent cohort suggesting a strong relationship with weight trajectories in the first six months after birth. Additionally, we developed a Methylation Risk Score (MRS) that could be used to identify children most at risk for developing childhood obesity. While many of the genes identified by our analysis have been associated with weight-related traits (e.g., glucose metabolism, BMI, or hip-to-waist ratio) in previous genome-wide association and variant studies, our analysis implicated several others, whose involvement in the obesity phenotype should be evaluated in future functional investigations.

Methylation profiles at birth linked to early childhood obesity.

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 methylation profiles in cord blood and placenta at birth were associated with weight outcomes (specifically, conditional weight gain, body mass index, and weight-for-length ratio) at age six months. We characterized genome-wide DNA methylation profiles using the Illumina Infinium MethylationEpic chip, and incorporated information on child and maternal health, and various environmental factors into the analysis. We used regression analysis to identify genes with methylation profiles most predictive of infant weight outcomes, finding a total of 23 relevant genes in cord blood and 10 in placenta. Notably, in cord blood, the methylation profiles of three genes (PLIN4, UBE2F, and PPP1R16B) were associated with all three weight outcomes, which are also associated with weight outcomes in an independent cohort suggesting a strong relationship with weight trajectories in the first six months after birth. Additionally, we developed a Methylation Risk Score (MRS) that could be used to identify children most at risk for developing childhood obesity. While many of the genes identified by our analysis have been associated with weight-related traits (e.g., glucose metabolism, BMI, or hip-to-waist ratio) in previous genome-wide association and variant studies, our analysis implicated several others, whose involvement in the obesity phenotype should be evaluated in future functional investigations.

Direct Sibling Influence on Eating Behavior in Early Childhood: Siblings as Role Models and Caregivers.

OBJECTIVE: Despite the majority of US children having at least 1 sibling, little is known about how siblings influence eating behavior and obesity risk. This qualitative study explored mothers' perceptions of older siblings' influences on younger siblings' eating behavior in the context of mealtimes in early childhood. METHODS: A purposive subsample of mothers (n = 30) who participated in the Intervention Nurses Start Infants Growing on Healthy Trajectories and SIBSIGHT studies completed retrospective semi-structured interviews designed to explore the implications of sibling influences on maternal feeding practices during infancy and toddlerhood. Interviews were conducted by video conference with mothers between January and March 2021. All interviews were audio-recorded, transcribed, and a qualitative content analysis approach was used to code and identify themes. RESULTS: Two main themes were identified related to the influence of older siblings on younger siblings during feeding interactions: 1) Older siblings as positive role models for younger siblings and 2) Older siblings acted as caregivers for younger siblings. Younger siblings received encouragement at mealtimes to try new foods. Older siblings assisted their mothers in caregiving and feeding tasks in developmentally appropriate ways. CONCLUSIONS: Findings may help to elucidate the role of older siblings in shaping eating behavior and obesity risk of siblings in early childhood. Better understanding the role of siblings can aid in the development of novel interventions and anticipatory nutrition guidance in family-based clinical and community care.

Sleep SAAF Responsive Parenting Intervention for Black Mothers Impacts Response to Infant Crying: A Randomized Clinical Trial.

OBJECTIVE: Many parents use food to soothe their infant, regardless of infant hunger, which can increase risk for rapid weight gain. Interventions promoting alternative soothing strategies may help parents respond more appropriately to crying. This secondary analysis aimed to examine effects of the Sleep SAAF (Strong African American Families) responsive parenting (RP) intervention on maternal responses to infant crying and to explore moderating effects of infant negativity. METHODS: Primiparous Black mothers (n = 212) were randomized to an RP or safety control intervention, delivered during home visits at 3 and 8 weeks postpartum. Parents were empowered to first use non-food soothing strategies (eg, white noise, swaddling) when responding to crying. Mothers completed the Babies Need Soothing questionnaire at 8 and 16 weeks, and the Infant Behavior Questionnaire at 16 weeks. Data were analyzed using linear or logistic regression. RESULTS: RP mothers were significantly more likely than controls to use shushing/white noise to soothe their infant at 8 (OR = 4.9, 95% CI: 2.2-10.6) and 16 weeks (OR = 4.8, 95% CI: 2.2-10.5), to go for a walk in stroller/ride in car at 8 weeks (OR = 2.3, 95% CI: 1.2-4.6), and to swing/rock/bounce their infant at 16 weeks (OR = 5.5, 95% CI: 1.2-25.7). RP mothers also reported significantly more frequent use of deep breathing, exercising, and bathing/showering than controls when frustrated with crying. Infant negativity moderated some intervention effects such that the RP intervention was more effective at increasing use of some soothing practices among mothers with less negative infants. CONCLUSIONS: An RP intervention positively impacted first-time Black mothers' responses to infant crying.

Toddler dietary patterns from the INSIGHT randomized clinical trial comparing responsive parenting versus control: A latent class analysis.

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 their infants. Mothers reported on feeding practices, as well as toddler diet with a Food Frequency Questionnaire (n = 229). Trained research staff obtained child anthropometrics at age 2 years. RESULTS: Latent class analysis identified three dietary patterns: high fruits and vegetables (HFV, 31%); meat, potatoes, and added sugars (MPAS, 24%); and high juice, low fruits and vegetables (JLFV, 45%). Toddler dietary pattern was not related to study group (RP, control) or child weight status at age 2 years. Mothers who reported more structure-based feeding had toddlers that were more likely to have the healthier, HFV dietary pattern than MPAS and JLFV. Findings for control-based feeding practices were mixed; maternal restriction was associated with the HFV dietary pattern, whereas the use of food as a reward was associated with MPAS and JLFV. CONCLUSIONS: Mothers' structure-based feeding practices in infancy, as well as some control-based feeding practices, were associated with later healthier toddler dietary patterns.

Designing a childhood obesity preventive intervention using the multiphase optimization strategy: The Healthy Bodies Project.

BACKGROUND/AIMS: Preventing the development of childhood obesity requires multilevel, multicomponent, comprehensive approaches. Study designs often do not allow for systematic evaluation of the efficacy of individual intervention components before the intervention is fully tested. As such, childhood obesity prevention programs may contain a mix of effective and ineffective components. This article describes the design and rationale of a childhood obesity preventive intervention developed using the multiphase optimization strategy, an engineering-inspired framework for optimizing behavioral interventions. Using a series of randomized experiments, the objective of the study was to systematically test, select, and refine candidate components to build an optimized childhood obesity preventive intervention to be evaluated in a subsequent randomized controlled trial. METHODS: A 24 full factorial design was used to test the individual and combined effects of four candidate intervention components intended to reduce the risk for childhood obesity. These components were designed with a focus on (a) improving children's healthy eating behaviors and nutrition knowledge, (b) increasing physical activity and reducing sedentary activity in the childcare setting, (c) improving children's behavioral self-regulation, and (d) providing parental web-based education to address child target outcomes. The components were tested with approximately 1400 preschool children, ages 3-5 years in center-based childcare programs in Pennsylvania, the majority of which served predominantly Head-Start eligible households. Primary child outcomes included healthy eating knowledge, physical and sedentary activity, and behavioral self-regulation. Secondary outcomes included children's body mass index and appetitive traits related to appetite regulation. RESULTS: Four intervention components were developed, including three classroom curricula designed to increase preschool children's nutrition knowledge, physical activity, and behavioral, emotional, and eating regulation. A web-based parent education component included 18 lessons designed to improve parenting practices and home environments that would bolster the effects of the classroom curricula. A plan for analyzing the specific contribution of each component to a larger intervention was developed and is described. The efficacy of the four components can be evaluated to determine the extent to which they, individually and in combination, produce detectable changes in childhood obesity risk factors. The resulting optimized intervention should later be evaluated in a randomized controlled trial, which may provide new information on promising targets for obesity prevention in young children. CONCLUSION: This research project highlights the ways in which an innovative approach to the design and initial evaluation of preventive interventions may increase the likelihood of long-term success. The lessons from this research project have implications for childhood obesity research as well as other preventive interventions that include multiple components, each targeting unique contributors to a multifaceted problem.

Effect of the INSIGHT Responsive Parenting Intervention on Parenting and Child Behavior at Ages 3 and 6 Years.

OBJECTIVES: To examine effects of the INSIGHT study responsive 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 home visits at infant ages 3-4, 16, 28, and 40 weeks and research center visits at 1 and 2 years. At age 3 (n = 220) and 6 years (n = 171) parenting and child behavior were observed during dyadic interactions and coded using the Iowa Family Interaction Rating Scales. Mothers also reported on child behavior (age 3) and aspects of general parenting (age 6) via the Child Behavior Checklist and The Comprehensive General Parenting Questionnaire, respectively. RESULTS: RP group children had fewer mother-reported externalizing (F = 8.69, P = .004) and problem behaviors at age 3 (F = 4.53, P = .03), and higher observed prosocial (F = 4.73, P = .03) and lower antisocial (ie, externalizing; F = 4.79, P = .03) behavior at age 6 vs controls. There were no study group differences in observed maternal sensitivity at age 3 or 6 years. At age 6, RP group mothers reported higher use of structure defined by establishing consistent rules and routines (F = 5.45, P = .02) and organization of their child's environment (F = 7.12, P = .008) compared with controls. CONCLUSIONS: The INSIGHT RP intervention increased parental organization of the child's environment to facilitate competence, and had beneficial impacts on child behavior at 3 and 6 years. No impacts were found on maternal sensitivity in childhood. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01167270.

Nutritional Status Differs by Prescription Opioid Use among Women of Reproductive Age: NHANES 1999-2018.

Prescription opioid use among pregnant women has increased in recent years. Prenatal exposure to opioids and poor nutrition can both negatively impact maternal-fetal outcomes. The objective of this study was to characterize the nutrition and health status of reproductive-age women taking prescription opioids, compared to women not taking opioids. Using NHANES 1999-2018 data, non-pregnant women aged 20-44 years were classified as taking a prescription opioid in the last 30 days (n = 404) or unexposed controls (n = 7234). Differences in anthropometric, cardiovascular, hematologic, and micronutrient status indicators between opioid-exposed and unexposed women were examined. Opioid-exposed women were older, had lower income and education, and were more likely to be non-Hispanic White, to smoke, and to have chronic health conditions compared to unexposed women. In unadjusted analyses, several nutrition and health markers were significantly different between opioid exposure groups. After controlling for covariates, women taking opioids had higher odds of Class II (OR = 1.6, 95% CI = 1.1-2.3) or III obesity (OR = 1.6, 95% CI = 1.1-2.5), and lower levels of serum folate, iron, and transferrin saturation. Reproductive-age women taking prescription opioids may be at risk for poorer nutritional and cardiometabolic health. Future research is needed to explore whether nutritional status impacts maternal-fetal outcomes for women exposed to opioids during pregnancy.

Effects of a Responsive Parenting Intervention Among Black Families on Infant Sleep: A Secondary Analysis of the Sleep SAAF Randomized Clinical Trial.

Importance: Black individuals in the US experience sleep disparities beginning in infancy and continuing throughout the lifespan, suggesting early interventions are needed to improve sleep. Objective: To investigate whether a responsive parenting (RP) intervention for Black mothers improves infant sleep and increases responsive sleep parenting practices. Design, Setting, and Participants: This is a post hoc secondary analysis of the Sleep SAAF (Strong African American Families) study, a randomized clinical trial comparing an RP intervention with a safety control condition over the first 16 weeks post partum. Data were collected between spring 2018 and summer 2021. Families were recruited from the mother-infant nursery at Augusta University Medical Center, Augusta, Georgia, and completed home visits at 1, 3, 8, and 16 weeks post partum. Primiparous Black mother-infant dyads were screened for eligibility using medical records. Results were analyzed on an intention-to-treat model. Data were analyzed from March 2022 to January 2023. Interventions: The RP intervention curriculum focused on infant sleep, soothing and crying, and feeding. The control group received a safety intervention. Community research associates delivered the interventions during home visits at 3 and 8 weeks post partum. Main Outcomes and Measures: The primary end point was infant sleep duration at 16 weeks. Mothers reported on bedtime routine and sleep behaviors, infant sleep duration, and nighttime waking and feeding at 8 and 16 weeks post partum using questionnaires. Results: A total of 212 Black mothers (mean [SD] age, 22.7 [4.5] years) were randomized, including 208 mothers (98.6%) who identified as non-Hispanic and 3 mothers (1.4%) who identified as Hispanic; 108 mothers were randomized to the RP group and 104 mothers were randomized to the control group. At 16 weeks post partum, infants in the RP group had longer reported nighttime sleep duration (mean difference, 40 [95% CI, 3 to 77] minutes), longer total sleep duration (mean difference, 73 [95% CI, 14 to 131] minutes), fewer nighttime wakings (mean difference, -0.4 [95% CI, -0.6 to -0.1] wakings), and greater likelihood of meeting guidelines of at least 12 hours of total sleep per day (risk ratio [RR], 1.4 [95% CI, 95% CI, 1.1 to 1.8]) than controls. Relative to controls, mothers in the RP group more frequently reported engaging in some RP practices, including giving the baby a few minutes to fall back asleep on their own (RR, 1.6 [95% CI, 1.0 to 2.6]) and being less likely to feed their baby as the last activity before bed (RR, 0.5 [95% CI, 0.3 to 0.8]). Conclusions and Relevance: This secondary analysis of a randomized clinical trial found that an RP intervention for Black families improved infant sleep and increased some responsive sleep parenting practices. Trial Registration: ClinicalTrials.gov Identifier: NCT03505203.

Constructing a polygenic risk score for childhood obesity using functional data analysis.

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 of thousands of individuals for whom a single summary measurement (e.g., BMI) is collected. An alternative approach is to focus on a smaller, more deeply characterized sample in conjunction with advanced statistical models that leverage longitudinal phenotypes. Novel functional data analysis (FDA) techniques are used to capitalize on longitudinal growth information from a cohort of children between birth and three years of age. In an ultra-high dimensional setting, hundreds of thousands of single nucleotide polymorphisms (SNPs) are screened, and selected SNPs are used to construct two polygenic risk scores (PRS) for childhood obesity using a weighting approach that incorporates the dynamic and joint nature of SNP effects. These scores are significantly higher in children with (vs. without) rapid infant weight gain-a predictor of obesity later in life. Using two independent cohorts, it is shown that the genetic variants identified in very young children are also informative in older children and in adults, consistent with early childhood obesity being predictive of obesity later in life. In contrast, PRSs based on SNPs identified by adult obesity GWAS are not predictive of weight gain in the cohort of young children. This provides an example of a successful application of FDA to GWAS. This application is complemented with simulations establishing that a deeply characterized sample can be just as, if not more, effective than a comparable study with a cross-sectional response. Overall, it is demonstrated that a deep, statistically sophisticated characterization of a longitudinal phenotype can provide increased statistical power to studies with relatively small sample sizes; and shows how FDA approaches can be used as an alternative to the traditional GWAS.

Feasibility and user acceptability of Breezing™, a mobile indirect calorimetry device, in pregnant women with overweight or obesity.

Emerging evidence has suggested that prenatal resting energy expenditure (REE) may be an important determinant of gestational weight gain. Advancements in technology such as the real-time, mobile indirect calorimetry device (Breezing™) have offered the novel opportunity to continuously assess prenatal REE while also potentially capturing fluctuations in REE. The purpose of this study was to examine feasibility and user acceptability of Breezing™ to assess weekly REE from 8-36 weeks gestation in pregnant women with overweight or obesity participating in the Healthy Mom Zone intervention study. Participants (N=27) completed REE assessments once per week from 8-36 gestation using Breezing™. Feasibility of the device was calculated as compliance (# of weeks used/total # of weeks). User acceptability was measured by asking women to report on the device's enjoyability and barriers. Median compliance was 68%. However, when weeks women experienced technical difficulties (11 of 702 total events) and the device was unavailable were removed (13 of 702 total events), median compliance increased to 71%. Over half (56%) of the women reported that the device was enjoyable or they had neutral feelings about it whereas the remaining 44% reported that it was not enjoyable. The most common barrier reported (44%) was the experience of technical issues. Study compliance data suggest the feasibility of using Breezing™ to assess prenatal REE is promising. However, acceptability data suggest future interventionists should develop transparent and informative protocols to address any barriers prior to implementing the device to increase use.

Appraisal of Clinical Care Practices for Child Obesity Treatment. Part II: Comorbidities.

The objective of this technical report is to provide clinicians with actionable evidence-based information upon which to make treatment decisions. In addition, this report will provide an evidence base on which to inform clinical practice guidelines for the management and treatment of overweight and obesity in children and adolescents. To this end, the goal of this report was to identify all relevant studies to answer 2 overarching key questions: (KQ1) "What are effective clinically based treatments for obesity?" and (KQ2) "What is the risk of comorbidities among children with obesity?" See Appendix 1 for the conceptual framework and a priori Key Questions.

Appraisal of Clinical Care Practices for Child Obesity Treatment. Part I: Interventions.

The objective of this technical report is to provide clinicians with evidence-based, actionable information upon which to make assessment and treatment decisions for children and adolescents with obesity. In addition, this report will provide an evidence base to inform clinical practice guidelines for the management and treatment of overweight and obesity in children and adolescents. To this end, the goal of this report was to identify all relevant studies to answer 2 overarching key questions: (KQ1) "What are clinically based, effective treatments for obesity?" and (KQ2) "What is the risk of comorbidities among children with obesity?" See Appendix 1 for the conceptual framework and a priori key questions.

Coordination Between Primary Care and Women, Infants, and Children to Prevent Obesity for Infants from Low-Income Families: A Pragmatic Randomized Clinical Trial.

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 Children Enhancements to Early Healthy Lifestyles for Baby (WEE Baby) Care study is a pragmatic, randomized clinical trial for mothers and infants (n = 288) designed to examine the effect of a patient-centered RP intervention that used advanced health information technology strategies to coordinate care to reduce rapid infant weight gain compared with standard care. General linear models examined intervention effects on infant conditional weight gain scores, weight-for-age z scores, BMI, and overweight status (BMI-for-age ≥85th percentile) from birth to age 6 months, and mothers' use of food to soothe from age 2 to 6 months. Results: There were no intervention effects on infant conditional weight gain scores or overweight status at 6 months. Infants in the RP intervention had lower mean weight-for-age z scores [M = -0.04, standard error (SE) = 0.04 vs. M = 0.05, SE = 0.04; p = 0.008] and lower mean BMI (M = 16.05, SE = 0.09 vs. M = 16.24, SE = 0.09; p = 0.03) compared with standard care. Mothers' use of emotion-based food to soothe was lower in the RP intervention compared with standard care from age 2 to 6 months [M difference = -0.32, standard deviation (SD) = 0.81 vs. 0.00, SD = 0.90; p = 0.01]. Conclusions: This pragmatic, patient-centered RP intervention did not reduce rapid infant weight gain or overweight but was associated with modestly lower infant BMI and reduced mothers' use of emotion-based food to soothe. Trial Registration: clinicaltrials.gov identifier: NCT03482908.

Resource dilution in maternal feeding practices after birth of a secondborn.

Firstborn children have higher prevalence of obesity than secondborn siblings. The birth of a sibling typically results in resource dilution when mothers begin to divide their time and attention between two children. This mixed-methods analysis applies the family systems process of resource dilution to test the hypothesis that characteristics of the secondborn impact how parents feed the firstborn. Participants (n = 76) were mothers of consecutively born firstborn and secondborn siblings who participated in the INSIGHT trial and an observational cohort. Quantitative analyses involved multilevel models to test if characteristics of secondborns (temperament at 16 weeks, appetite at 28 weeks) were associated with maternal feeding practices of firstborns (structure and control-based feeding) at 1, 2, and 3 years, adjusting for firstborn child characteristics. A purposive subsample (n = 30) of mothers participated in semi-structured interviews to contextualize potential sibling influences on maternal feeding practices during infancy and toddlerhood. Quantitative data showed secondborn temperament and appetite were associated with how mothers fed their firstborn. Qualitative data explained maternal feeding practices in three primary ways: 1) Mothers explained shifting predictable meal and snack routines after birth of the secondborn, but did not perceive sibling characteristics as the source; 2) Family chaos following the secondborn's birth led to "survival mode" in feeding; and 3) Social support was protective against feeding resource dilution. The family systems process of resource dilution is a focus for future research and support for families during key transitions and a direction for efforts to reduce risk for child obesity.

Development and Psychometric Properties of the Sleep Parenting Scale for Infants.

Although infants' sleep behaviors are shaped by their interactions with parents at bedtime, few tools exist to capture parents' sleep parenting practices. This study developed a Sleep Parenting Scale for Infants (SPS-I) and aimed to (1) explore and validate its factorial structure, (2) examine its measurement invariance across mothers and fathers, and (3) investigate its reliability and concurrent and convergent validity. SPS-I was developed via a combination of items modified from existing scales and the development of novel items. Participants included 188 mothers and 152 mother-father dyads resulting in 340 mothers and 152 fathers; about half were non-Hispanic white. Mothers and fathers completed a 14-item SPS-I for their 12-month-old infant. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to explore and validate SPS-I's underlying structure. Multigroup CFA was used to examine measurement invariance across mothers and fathers. Reliability was examined using Cronbach's alpha. Concurrent validity was assessed using linear regressions examining associations between SPS-I factors and parent-reported infants nighttime sleep duration. Convergent validity was assessed using paired-sample t-tests to test whether the SPS-I subscale scores were similar between mothers and fathers in the same household. EFA and CFA confirmed a 3-factor, 12-item model: sleep routines, sleep autonomy, and screen media in the sleep environment. SPS-I was invariant across mothers and fathers and was reliable. Concurrent and convergent validity were established. SPS-I has good psychometric properties, supporting its use for characterizing sleep routines, sleep autonomy, and screen media in the sleep environment by mothers and fathers.Supplemental data for this article is available online at https://doi.org/10.1080/08964289.2021.2002799 .

Comparing enhancements to well-child visits in the prevention of obesity: ENCIRCLE cluster-randomized controlled trial.

BACKGROUND: Obesity disproportionally impacts rural, lower-income children in the United States. Primary care providers are well-positioned to engage parents in early obesity prevention, yet there is a lack of evidence regarding the most effective care delivery models. The ENCIRCLE study, a pragmatic cluster-randomized controlled trial, will respond to this gap by testing the comparative effectiveness of standard care well-child visits (WCV) versus two enhancements: adding a patient-reported outcome (PRO) measure (PRO WCV) and PRO WCV plus Food Care (telehealth coaching and a grocery store tour). METHODS: A total of 2,025 parents and their preschool-aged children (20-60 months of age) will be recruited from 24 Geisinger primary care clinics, where providers are randomized to the standard WCV, PRO WCV, or PRO WCV plus Food Care intervention arms. The PRO WCV includes the standard WCV plus collection of the PRO-the Family Nutrition and Physical Activity (FNPA) risk assessment-from parents. Parents complete the PRO in the patient-portal or in the clinic (own device, tablet, or kiosk), receive real-time feedback, and select priority topics to discuss with the provider. These results are integrated into the child's electronic health record to inform personalized preventive counseling by providers. PRO WCV plus Food Care includes referrals to community health professionals who deliver evidence-based obesity prevention and food resource management interventions via telehealth following the WCV. The primary study outcome is change in child body mass index z-score (BMIz), based on the World Health Organization growth standards, 12 months post-baseline WCV. Additional outcomes include percent of children with overweight and obesity, raw BMI, BMI50, BMIz extended, parent involvement in counseling, health behaviors, food resource management, and implementation process measures. DISCUSSION: Study findings will inform health care systems' choices about effective care delivery models to prevent childhood obesity among a high-risk population. Additionally, dissemination will be informed by an evaluation of mediating, moderating, and implementation factors. TRIAL REGISTRATION: ClinicalTrials.gov identifier (NCT04406441); Registered May 28, 2020.

Patient-reported outcome measures can advance population health, but is access to instruments and use equitable?

Patient reported outcome measures (PROM) can engage patients and clinicians to improve health outcomes. Their population health impact may be limited by systematic barriers inhibiting access to completion. In this analysis we evaluated the association between individual parent/child characteristics and clinic factors with parental completion of a locally developed PROM, the Early Healthy Lifestyles (EHL) questionnaire. Participants included parent-child dyads who presented at 14 pediatric clinics for regularly scheduled well-child visits (WCV) prior to age 26 months. EHL items include feeding practices, diet, play time, screen exposure, and sleep. Completion was categorized at patient- (i.e., parent-child dyad) and clinic-levels. Parents completed the 15-item EHL in the patient portal before arrival or in the clinic; ninety-three percent of EHL questionnaires were completed in the clinic vs. 7% in the patient portal. High-completers completed EHL for half of WCVs; low-completers completed at least once; and non-completers never completed. Clinics were classified by EHL adoption level (% high completion): High-adoption: >50%; Moderate-adoption: 10%-50%; and Low-adoption: <10%. Individual-level factors had negligible impact on EHL completion within moderate/low EHL adoption sites; high-adoption sites were used to evaluate infant and maternal factors in association with EHL completion using hierarchical logistic regression. Noncompletion of EHL was significantly associated (p < 0.05) with infant use of public insurance (OR = 1.92 [1.42, 2.59]), >1 clinic site for WCV (OR = 1.83 [1.34, 2.50]), non-White birth mother (OR = 1.78 [1.28, 2.47]), and body weight <2,500 grams or gestational age <34 weeks (OR = 1.74 [1.05, 2.90]). The number of WCVs, a proxy for clinic size, was evaluated but was not associated with completion. Findings indicate potential disparities between populations exposed to, completing, and benefitting from these tools.