Costs to Implement a Pediatric Weight Management Program Across 3 Distinct Contexts.

BACKGROUND: The Connect for Health program is an evidence-based program that aligns with national recommendations for pediatric weight management and includes clinical decision support, educational handouts, and community resources. As implementation costs are a major driver of program adoption and maintenance decisions, we assessed the costs to implement the Connect for Health program across 3 health systems that primarily serve low-income communities with a high prevalence of childhood obesity. METHODS: We used time-driven activity-based costing methods. Each health system (site) developed a process map and a detailed report of all implementation actions taken, aligned with major implementation requirements (eg, electronic health record integration) or strategies (eg, providing clinician training). For each action, sites identified the personnel involved and estimated the time they spent, allowing us to estimate the total costs of implementation and breakdown costs by major implementation activities. RESULTS: Process maps indicated that the program integrated easily into well-child visits. Overall implementation costs ranged from $77,103 (Prisma Health) to $84,954 (Denver Health) to $142,721 (Massachusetts General Hospital). Across implementation activities, setting up the technological aspects of the program was a major driver of costs. Other cost drivers included training, engaging stakeholders, and audit and feedback activities, though there was variability across systems based on organizational context and implementation choices. CONCLUSIONS: Our work highlights the major cost drivers of implementing the Connect for Health program. Accounting for context-specific considerations when assessing the costs of implementation is crucial, especially to facilitate accurate projections of implementation costs in future settings.

Examining Health Conditions, Impairments, and Quality of Life for Pediatric Feeding Disorders.

By understanding health conditions, impairments, and impact on quality of life for pediatric feeding disorders, assessment and treatment approaches can target multiple levels of health-related domains that improve child health and well-being. The purpose of this study was to characterize medical diagnoses and feeding impairments for children with feeding disorders; examine child quality of life and caregiver impact; and compare quality of life differences between children with feeding disorders and children with other conditions. A cross-sectional study was conducted in the Greater Boston Area, between October 2017 and June 2018. Fifty children with a feeding disorder diagnosis, ages 2-5 years, were enrolled. Demographic and clinical data were abstracted from the electronic health record to characterize medical diagnoses and impairments. Parents completed the Pediatric Quality of Life Generic Core Scales 4.0 (PedsQL) and the Feeding/Swallowing Impact Survey (FS-IS) to understand child quality of life and caregiver impact. We calculated descriptive statistics across the medical diagnosis and impairment groups, and for the surveys. Children presented with heterogeneous medical diagnoses and feeding impairments. We found a mean (SD) total score of 72.82(19.21) on the PedsQL and 2.33(0.89) on the FS-IS demonstrating that children with feeding disorders presented with poor quality of life and their caregivers were negatively impacted by their feeding difficulties. By understanding medical diagnoses, impairments, and quality of life, assessment and treatment methods can be tailored to children's specific needs, as well as address the overall wellbeing of children and their families.

Financial impacts and community resources utilization of children with feeding difficulties.

BACKGROUND: To examine the extent to which financial impacts and community resources utilization are associated with pediatric feeding difficulties. We hypothesize that children with feeding difficulties will have more financial impacts and community resources utilization than children without feeding difficulties. METHODS: We conducted a secondary analysis of cross-sectional data from the 2017-2018 National Survey of Children's Health (NSCH) regarding 14,960 children 0-5 years. NSCH utilized random sampling of families across the United States to collect nationally representative data. Outcomes included out-of-pocket costs, caregivers leaving a job due to the child's health, food insufficiency, receival of food or cash assistance, and receival of special education and/or developmental services. We used a multivariable logistic regression controlling for sociodemographic factors to examine the associations of feeding difficulties with financial impacts and community resources utilization outcomes. RESULTS: Out of 14,690 respondents, children were a mean (SD) age of 2.53(0.03) years and 1.7% reported feeding difficulties. These children had higher odds of having out-of-pocket costs of ≥$1000 (OR: 3.01; 95% CI: 1.61, 5.62), having a caregiver that left a job due to their child's health (OR: 3.16; 95% CI: 2.01, 4.98), experiencing food insufficiency (OR: 1.67; 95% CI: 1.03, 2.71), and receiving special education and/or developmental services (OR 3.98; 95% CI: 2.46, 6.45) than children without feeding difficulties. CONCLUSIONS: Children with feeding difficulties are more likely to have financial impacts and community resources utilization than children without feeding difficulties. This information can be used to tailor interventions to improve family-centered care and outcomes for children.

Effects of the First 1000 Days Program, a systems-change intervention, on obesity risk factors during pregnancy.

BACKGROUND: First 1000 Days is a systems-oriented program starting in early pregnancy lasting through the first 24 months of infancy focused on preventing obesity and related risk factors among low income, mother-infant pairs. The program was developed in partnership with stakeholders to create an infrastructure for system-wide change. It includes screening for adverse health behaviors and socio-contextual factors, patient navigation and educational materials to support behavior change and social needs, and individualized health coaching for women at highest risk of obesity and has been shown to reduce excess gestational weight gain for women who were overweight at the start of their pregnancy. The purpose of this study was to examine changes from the first to third trimester for women participating in the First 1000 Days Program. METHODS: We collected information through self-administered questionnaires during the first and third trimester of gestation and from electronic health records relating to obesity risk factors. Measures collected included behavior (i.e., diet, physical activity and screen time) and psychosocial (i.e., anxiety) outcomes, as well as enrollment in Women, Infant, and Children (WIC) program. We examined the extent to which participation in the program was associated with changes in behaviors and psychosocial outcomes among women during pregnancy. RESULTS: Women completed surveys at their initial and third trimester prenatal visits (n = 264). Mean age (SD) was 30.2 (5.51) years and 75% had an annual household income of <$50,000. Mean pre-pregnancy body mass index (BMI) was 27.7 kg/m2 and 64% started pregnancy with a BMI ≥ 25 kg/m2. In multivariable adjusted models, we observed decreases in intake of sugary-drinks (- 0.95 servings/day; 95% CI: - 1.86, - 0.03) and in screen time (- 0.21 h/day; 95% CI: - 0.40, - 0.01), and an increase in physical activity (0.88 days/week; 95% CI: 0.52, 1.23) from the first to third trimester. We also observed a decrease in pregnancy-related anxiety score (- 1.06 units; 95% CI: - 1.32, - 0.79) and higher odds of enrollment in Women, Infant, and Children (WIC) program (OR: 2.58; 95% CI: 1.96, 3.41). CONCLUSIONS: Our findings suggest that a systems-oriented prenatal intervention may be associated with improvements in behaviors and psychosocial outcomes during pregnancy among low-income mothers. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT03191591 ; Retrospectively registered on June 19, 2017).

Association of sugar-sweetened beverage intake with maternal postpartum weight retention.

OBJECTIVE: During the perinatal period, modifiable behaviours contributing to excess weight gain, including sugar-sweetened beverage (SSB) intake, are understudied. We examined the extent to which perinatal SSB intake affects postpartum weight retention (PPWR). DESIGN: We measured SSB intake frequency in the third trimester and 1-month postpartum using the NHANES Dietary Screener Questionnaire. We assessed the association between SSB intake and PPWR (difference between 6-month postpartum and pregravid weight) using multivariable regression adjusted for socio-demographic and anthropometric variables. SETTING: Greater Boston area. PARTICIPANTS: Three hundred forty-eight mother-infant pairs in the Rise and SHINE prospective birth cohort. RESULTS: Mean age was 32·7 (sd 5·0) years; the sample was 47 % white, 32 % Hispanic, 14 % Asian and 7 % Black. Women reported mean daily SSB intake frequencies of 0·9 (sd 1·2) and 0·7 (sd 1·0) times/d in the third trimester and 1-month postpartum, respectively. At 6-month postpartum, average weight retention was 3·4 (sd 5·7) kg; 108 (sd 31 %) women had substantial PPWR, defined as a ≥ 5 kg increase between pregravid and 6-month postpartum weight. Each 1-time/d increment in SSB intake frequency during the third trimester (ß = 0·46 kg (95 % CI, 0·07, 0·86)) and 1-month postpartum (ß = 0·52 kg (95 % CI 0·03, 1·00)) was associated with higher weight retention at 6 months. Increased SSB intake frequency in the third trimester (OR: 1·37; 95 % CI 1·10, 1·75) and 1-month postpartum (OR: 1·17; 95 % CI 0·92, 1·52) resulted in higher odds of substantial PPWR. CONCLUSIONS: SSB consumption during the perinatal period is associated with higher weight retention at 6-month postpartum. Avoiding SSB may reduce the risk of excess weight retention.

Paediatric oral sensorimotor interventions for chewing dysfunction: A scoping review.

BACKGROUND: Chewing dysfunction can have adverse effects on growth, development and quality of life. There is a lack of evidence-based consensus guidelines for sensorimotor intervention. To address this, we need to understand the current state of the science in clinical sensorimotor interventions for paediatric chewing dysfunction and systematically plan a research agenda and priorities for the field. AIMS: The purpose of this scoping review was to examine the extent, range and nature of evidence for oral sensorimotor interventions for paediatric chewing dysfunction. METHODS & PROCEDURES: This scoping review entailed five phases that included: identification of the research question; identification of relevant studies; study selection; data charting; and collation, summarization and report of the results. Treatment studies that were peer-reviewed and written in English were included. All studies involved a paediatric population and included an oral sensorimotor and/or chewing intervention. Information regarding study design, population, intervention, comparator, outcome measures and findings were extracted. MAIN CONTRIBUTION: Of the 21 studies included in this scoping review, 53% were specific to children with cerebral palsy. All interventions were multi-component in nature and the treatment studies included a range of study designs, but few were controlled trials with comparators. A wide variety of outcomes measures were used within and across studies to determine treatment effectiveness. CONCLUSIONS & IMPLICATIONS: The findings suggest that in a small number of studies, sensorimotor interventions provide preliminary evidence for effectiveness in specific populations. These and other treatment protocols must be trialled in additional clinical populations and settings to improve the evidence base for sensorimotor treatment of paediatric chewing dysfunction. This review also serves to help prioritize research agendas and further motivates the need for consensus-based clinical guidelines for paediatric chewing treatment. WHAT THIS PAPER ADDS: What is already known on the subject Paediatric feeding disorders are highly prevalent and children often have chewing dysfunction that results in significant negative consequences. We lack evidence-based sensorimotor treatment approaches for chewing dysfunction, which directly impacts the care clinicians can provide children. What this study adds to existing knowledge This scoping review is the first step in examining the literature to understand the current state of the science for oral sensorimotor interventions for paediatric chewing dysfunction. Few randomized controlled studies were identified and a majority included children with cerebral palsy. Most of the interventions were multi-component and included a variety of treatment approaches. What are the potential or actual clinical implications of this work? The results of this scoping review can be used as an initial reference for clinicians selecting treatment approaches for chewing dysfunction. It also serves to help prioritize research agendas and further motivates the need for consensus-based clinical guidelines for paediatric chewing treatment.

Family-centered Outcomes that Matter Most to Parents: A Pediatric Feeding Disorders Qualitative Study.

OBJECTIVE: The purpose of this study was to examine the perspectives of caregivers of children with feeding disorders. We sought to understand their child's feeding impairment through the lens of caregivers, including the impact impairments had on daily life and social participation, what outcomes matter most to caregivers, contextual determinants that affect achieving desired outcomes, and how treatment approaches can optimally support families. METHODS: We interviewed caregivers of children, ages 2 to 5 years, who received care at the Center for Feeding and Nutrition at MassGeneral Hospital for Children in Boston, MA. All children had a feeding disorder diagnosis, defined as an impairment in oral intake. We analyzed interview transcripts using principles of immersion-crystallization. RESULTS: We reached thematic saturation after interviewing 30 caregivers (25 female). 66.7% of the children were white, 13.3% Asian, 10.0% black, and 10.0% were more than 1 race. Thirty percent were Hispanic. We identified four themes: feeding impairments impact the daily life and social participation of children; improving their child's health and quality of life is most important to caregivers; child, caregiver, and community factors are facilitators of achieving desired outcomes; whereas time, financial, access, and knowledge factors are barriers; and caregivers prefer treatment approaches that incorporate principles of family-centered care. CONCLUSIONS: Given the daily life and social participation impacts of pediatric feeding disorders, treatment approaches should be family-centered, focus on functional and meaningful outcomes to improve the health and quality of life of children and their families, and address modifiable sociocontextual determinants.

Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool.

BACKGROUND: Incorporating family-centered care principles into childhood obesity interventions is integral for improved clinical decision making, better follow-through, and more effective communication that leads to better outcomes and greater satisfaction with services. The purpose of this study is to evaluate the psychometric properties of a modified version of the Family Centered-Care Assessment (mFCCA) tool and to assess the family-centeredness of two clinical-community childhood obesity interventions. METHODS: Connect for Health was a randomized trial testing the comparative effectiveness of two interventions that enrolled 721 children, ages 2-12 years, with a body mass index (BMI) ≥ 85th percentile. The two arms were (1) enhanced primary care; and (2) enhanced primary care plus contextually-tailored, health coaching. At the end of the one-year intervention, the mFCCA was administered. We used Rasch analyses to assess the tool's psychometrics and examined differences between the groups using multiple linear regression. RESULTS: 629 parents completed the mFCCA resulting in an 87% response rate. The mean (SD) age of children was 8.0 (3.0) years. The exploratory factor analysis with 24 items all loaded onto a single factor. The Rasch modeling demonstrated good reliability as evidenced by the person separation reliability coefficient (0.99), and strong validity as evidenced by the range of item difficulty and overall model fit. The mean (SD, range) mFCCA score was 4.14 (0.85, 1-5). Compared to parents of children in the enhanced primary care arm, those whose children were in the enhanced primary care plus health coaching arm had higher mFCCA scores indicating greater perception of family-centeredness (ß = 0.61 units [95% CI: 0.49, 0.73]). CONCLUSIONS: Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management. TRIAL REGISTRATION: Clinicaltrials.gov NCT02124460.

Psychosocial status and prenatal care of unintended pregnancies among low-income women.

BACKGROUND: Nearly half of all pregnancies in the United States are reported as unintended and rates are highest among women of low socioeconomic status. The purpose of this study was to examine the associations between unintended pregnancies and maternal mental health and timing of prenatal care among low-income women. METHODS: In this cross-sectional study, 870 women, whom were participating in the First 1000 Days program in three community health centers in the Boston area, were enrolled at their first prenatal visit from August 2016 - September 2017. We assessed pregnancy intention by self-report using the Pregnancy Risk Assessment Monitoring System. We used self-reported survey information and electronic health record data to assess the following outcomes: current stress, current depression, and timing of initial prenatal visit. We used multivariable logistic regression models to examine associations and adjusted for sociodemographic factors. RESULTS: Women were a mean (SD) age of 29.3 (6.1), and 39.2% reported that their pregnancy was unintended. 50.6% of women were Hispanic, 28.4% were White, 10.1% were Black, and 10.9% were other races. 78.9% of women reported an annual household income <$50,000. Overall, 26.7% of women reported current stress, 8.2% reported current depression, and 18.3% of women initiated prenatal care after their first trimester. In multivariable analyses, women with unintended pregnancies had higher odds of experiencing current stress (OR: 1.72; 95% CI: 1.22, 2.41), current depression (OR: 1.83; 95% CI: 1.04, 3.20), and initiation of prenatal care post-first trimester (OR: 1.84; 95% CI: 1.23, 2.74). CONCLUSIONS: Unintended pregnancies were associated with current stress and depression, and delayed prenatal care in this sample of low-income women suggesting the importance of identifying high-risk women and tailoring interventions to support women's needs. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03191591; Retrospectively registered on June 19, 2017).

An exploratory investigation of the effects of whole-head vibration on jaw movements.

The perturbing effects of vibration applied to head and body structures are known to destabilize motor control and elicit corrective responses. Although such vibration response testing may be informative for identifying sensorimotor deficits, the effect of whole-head vibration has not been tested on oromotor control. The purpose of this study was to determine how jaw movements respond to the perturbing effects of whole-head vibration during jaw motor tasks. Ten healthy adults completed speech, chewing, and two syllable repetition tasks with and without whole-head vibration. Jaw movements were recorded using 3D optical motion capture. The results showed that the direction and magnitude of the response were dependent on the task. The two syllable repetition tasks responded to vibration, although the direction of the effect differed for the two tasks. Specifically, during vibration, jaw movements became slower and smaller during the syllable repetition task that imposed speed and spatial precision demands, whereas jaw movements became faster and larger during the syllable repetition task that only imposed speed demands. In contrast, jaw movements were unaffected by the vibration during speech and chewing. These findings suggest that the response to vibration may be dependent on spatiotemporal demands, the availability of residual afferent information, and robust feedforward models.

Validation of Clinical Observations of Mastication in Persons with ALS.

Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that can result in difficulties with mastication leading to malnutrition, choking or aspiration, and reduced quality of life. When evaluating mastication, clinicians primarily observe spatial and temporal aspects of jaw motion. The reliability and validity of clinical observations for detecting jaw movement abnormalities is unknown. The purpose of this study is to determine the reliability and validity of clinician-based ratings of chewing performance in neuro-typical controls and persons with varying degrees of chewing impairments due to ALS. Adults chewed a solid food consistency while full-face video were recorded along with jaw kinematic data using a 3D optical motion capture system. Five experienced speech-language pathologists watched the videos and rated the spatial and temporal aspects of chewing performance. The jaw kinematic data served as the gold-standard for validating the clinicians' ratings. Results showed that the clinician-based rating of temporal aspects of chewing performance had strong inter-rater reliability and correlated well with comparable kinematic measures. In contrast, the reliability of rating the spatial and spatiotemporal aspects of chewing (i.e., range of motion of the jaw, consistency of the chewing pattern) was mixed. Specifically, ratings of range of motion were at best only moderately reliable. Ratings of chewing movement consistency were reliable but only weakly correlated with comparable measures of jaw kinematics. These findings suggest that clinician ratings of temporal aspects of chewing are appropriate for clinical use, whereas ratings of the spatial and spatiotemporal aspects of chewing may not be reliable or valid.

Development of an Infantile GM2 Clinical Rating Scale: Remote Assessment of Clinically Meaningful Health-Related Function.

GM2 gangliosidoses (GM2) are a group of rare lysosomal storage disorders in which accumulation of GM2 gangliosides results in progressive central nervous system damage. The infantile GM2 phenotype is characterized by delays in milestones by 6 months of age, followed by rapid loss of motor, cognitive, and visual function. Advancements in early diagnosis and pharmacotherapies provide promise for improved outcomes. However, the lack of feasible and clinically meaningful clinical outcome assessments for GM2 poses a challenge to characterizing GM2 natural history and selecting clinical trial endpoints. The purpose of this study was to develop a remotely administered infantile GM2 rating scale to measure health-related function in children with infantile GM2. A 2-phase mixed methods design was employed. In phase 1 of the study, 8 families of children with Infantile GM2 completed a natural history survey and a 1:1 semistructured interview to provide caregiver perspectives on the impacts of GM2 on health-related function. In phase 2 of the study, 8 expert clinicians provided feedback via surveys and participated in videoconference-hosted focus groups to refine scale administration and scoring procedures. These methods guided the development of 16 scale items to assess function in 5 health-related function domains: vision, hand and arm use, communication, gross motor, and feeding. This study used caregiver perspectives and expert clinician feedback to develop a remotely administered clinical outcome assessment of clinically meaningful health-related function in children with infantile GM2. Future studies will further evaluate the feasibility, reliability, and validity of the Infantile GM2 Clinical Rating Scale.

Psychometrics of the modified Family-Centered Care Assessment short version for childhood obesity.

Background: Incorporating principles of family-centered care into pediatric weight management interventions can improve the effectiveness and quality of treatment and reduce attrition rates. To assess the family-centeredness of interventions, reliable, valid, and easy-to-administer scales are needed. The purpose of the study was to develop a shortened version of the modifed Family Centered Care Assessment (mFCCA) and assess its psychometric properties. Methods: The mFCCA, a scale to assess the family-centeredness of interventions for childhood obesity, was administered to families following the Connect for Health randomized control trial evaluating the effectiveness of a primary care-based pediatric weight management intervention. We iteratively removed items from the mFCCA and used Rasch modeling to examine the reliability and validity of the shortened scale. Results: We included data from 318 parents and the exploratory factor analysis showed the presence of a single factor. The results of the Rasch modeling demonstrated acceptable internal consistency of the scale (0.7) and strong validity as evidenced by the overall model fit and range of item difficulty. Following the psychometric analyses, we reduced the number of items from 24 to 8 items. Conclusions: The mFCCA short version demonstrates good psychometrics and can be used to evaluate the family-centeredness of childhood obesity interventions with reduced participant burden, thereby improving outcomes for children with obesity. Trial registration: Clinicaltrials.gov NCT02124460 registered on April 24, 2014.

Evaluating the Implementation of the Connect for Health Pediatric Weight Management Program.

Importance: Adoption of primary care interventions to reduce childhood obesity is limited. Progress in reducing obesity prevalence and eliminating disparities can be achieved by implementing effective childhood obesity management interventions in primary care settings. Objective: To examine the extent to which implementation strategies supported the uptake of research evidence and implementation of the Connect for Health pediatric weight management program. Design, Setting, and Participants: This quality improvement study took place at 3 geographically and demographically diverse health care organizations with substantially high numbers of children living in low-income communities in Denver, Colorado; Boston, Massachusetts; and Greenville, South Carolina, from November 2019 to April 2022. Participants included pediatric primary care clinicians and staff and families with children aged 2 to 12 years with a body mass index (BMI) in the 85th percentile or higher. Exposures: Pediatric weight management program with clinician-facing tools (ie, clinical decision support tools) and family-facing tools (ie, educational handouts, text messaging program, community resource guide) along with implementation strategies (ie, training and feedback, technical assistance, virtual learning community, aligning with hospital performance metrics) to support the uptake. Main Outcomes and Measures: Primary outcomes were constructs from the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Framework examined through parent, clinician, and leadership surveys and electronic health record data to understand the number of children screened and identified, use of the clinical decision support tools, program acceptability, fidelity to the intervention and implementation strategies, and program sustainability. Results: The program screened and identified 18 333 children across 3 organizations (Denver Health, 8480 children [46.3%]; mean [SD] age, 7.97 [3.31] years; 3863 [45.5%] female; Massachusetts General Hospital (MGH), 6190 children [33.8%]; mean [SD] age, 7.49 [3.19] years; 2920 [47.2%] female; Prisma Health, 3663 children [20.0%]; mean [SD] age, 7.33 [3.15] years; 1692 [46.2%] female) as having an elevated BMI. The actionable flagging system was used for 8718 children (48%). The reach was equitable, with 7843 children (92.4%) from Denver Health, 4071 children (65.8%) from MGH, and 1720 children (47%) from Prisma Health being from racially and ethnically minoritized groups. The sites had high fidelity to the program and 6 implementation strategies, with 4 strategies (67%) used consistently at Denver Health, 6 (100%) at MGH, and 5 (83%) at Prisma Health. A high program acceptability was found across the 3 health care organizations; for example, the mean (SD) Acceptability of Intervention Measure score was 3.72 (0.84) at Denver Health, 3.82 (0.86) at MGH, and 4.28 (0.68) at Prisma Health. The implementation strategies were associated with 7091 (39%) uses of the clinical decision support tool. The mean (SD) program sustainability scores were 4.46 (1.61) at Denver Health, 5.63 (1.28) at MGH, and 5.54 (0.92) at Prisma Health. Conclusions and Relevance: These findings suggest that by understanding what strategies enable the adoption of scalable and implementation-ready programs by other health care organizations, it is feasible to improve the screening, identification, and management of children with overweight or obesity and mitigate existing disparities.

Helping Us Grow Stronger (HUGS)/Abrazos: a community-based initiative improved perinatal mental health in an urban cohort.

BACKGROUND: Targeted programs aimed at improving maternal mental health, particularly among those exposed to social determinants of health, are increasingly critical since the onset of the COVID-19 pandemic, yet the impact of such programs is poorly understood. OBJECTIVE: This study aimed to evaluate the impact of a novel, language-concordant community-based program on perinatal mental health. STUDY DESIGN: We conducted a prospective cohort study of peripartum individuals referred to a new community-based intervention known as Helping Us Grow Stronger (HUGS/Abrazos). Participants received up to 4 remote sessions with a cognitive behavioral therapy trained social worker, up to 3 resource navigation sessions with a community health worker, and direct relief with a grocery gift card and care package. Before and after the program, participants completed validated survey instruments to assess mental health and social determinants of health. RESULTS: A total of 178 participants were assessed after program completion, including 133 who were assessed before and after the program. The cohort was composed of 62.9% Hispanic or Latinx participants with a mean age of 29.8 year (standard error of mean, 0.46). There were high rates of food insecurity (111/178; 62.4%), experiences of discrimination (119/178; 66.9%), and SARS-CoV-2 infection (105/178; 59.0%). The program was associated with statistically significant improvements in the Edinburgh Postnatal Depression scores (baseline [mean±standard error of mean], 8.44±0.55 vs 6.77±0.51 after program completion; P=.0001) and Perceived Stress Scale scores (baseline, 15.2±0.74 vs 14.0±0.71; P=.035). Participants exposed to stressors including food insecurity and experiences of discrimination had higher baseline depression, stress, and anxiety scores. Those with experiences of discrimination, food insecurity, and SARS-CoV-2 infection during pregnancy were more likely to have improvements in mental health scores postintervention. CONCLUSION: In this diverse urban cohort, a novel community-based intervention was associated with improvements in depressive symptoms, perceived stress, and anxiety, particularly among those with social determinants of health.

The association of food insecurity on body mass index change in a pediatric weight management intervention.

BACKGROUND: Childhood obesity is a critical public health concern. One potential determinant to obesity that is less understood is food insecurity. OBJECTIVE: To examine the association of food security status on body mass index (BMI) change in a Pediatric Weight Management Intervention (PWMI) consistent with national treatment recommendations. METHODS: This analysis included 201 participants from the Healthy Weight Clinic (HWC). Using linear mixed models, we compared BMI and %BMIp95 change per year between the food insecure group and food secure group, adjusting for baseline BMI, age and sex, and SNAP enrolment. RESULTS: In fully adjusted models, children in households with food insecurity had a 0.50 (0.26-0.74) kg/m2 BMI increase per year and a 2.10 (1.02-3.19) %BMIp95 increase per year compared to households that were food secure. CONCLUSIONS: When comparing the BMI effect of the HWC between the food insecure group and food secure group, those experiencing food insecurity in the HWC had an increase in BMI compared to those with food security. These findings suggest that food insecurity may reduce the effectiveness of PWMIs consistent with national recommendations; however, more studies should be conducted to better understand this relationship.

Assessing the market viability of a packaged intensive health behavior and lifestyle treatment.

In the USA, more than 14 million children are impacted by obesity. Despite intensive health behavior and lifestyle treatments being found effective, gaps exist in moving these interventions into widespread use. Focusing on market viability could improve the dissemination and sustainment of interventions. The purpose of this paper is to outline the process and results of our market viability assessment for the Healthy Weight Clinic (HWC), a Centers for Disease Control and Prevention-recognized Family Health Weight Program. We conducted a market viability assessment using the Speeding Research-test INTerventions (SPRINT) program to gain insights into the commercialization and marketplace for the HWC. Through the process of customer discovery, we interviewed 50 stakeholders to test our hypotheses pertaining to our business model. Key takeaways were the need for packaged interventions that offer support and training for providers, and interventions that are multidisciplinary and located within the medical home. We also learned that (i) the intervention goals must align with the healthcare organization's performance metrics; (ii) services need to be reimbursable; and (iii) the importance of understanding different customer segments (i.e. program users vs. organization decision-makers) and their unique needs. The market viability assessment is a critical step to transforming the HWC into a viable commercial product. The process we have outlined is replicable by others and by encouraging other teams to design for dissemination we can increase the number of evidence-based, packaged IHBLTs available to children with obesity.

In the USA, more than 14 million children are impacted by obesity but few evidence-based interventions are available in the pediatric primary care setting. Focusing on the market viability of evidence-based, intensive health behavior and lifestyle treatments (IHBLT) could improve their dissemination and sustainment. The purpose of this paper is to outline the process and results of our market viability assessment of an intensive health behavior and lifestyle treatment, the Healthy Weight Clinic (HWC), a recognized Centers for Disease Control and Prevention Family Healthy Weight Program. We enrolled in the Speeding Research-test INTerventions (SPRINT) program to understand how to market the HWC by understanding customers' perspectives. Key takeaways include the need for packaged, multidisciplinary interventions in the medical home, ensuring the intervention is reimbursable and aligned with organization's performance metrics, and the importance of knowing customer segments and their needs. This paper addresses the gap pertaining to the market viability of pediatric IHBLT and provides a real-world example of how to conduct an assessment. Additionally, it outlines the process and provides the steps necessary for other researchers to understand the market forces that may impact the viability of their intervention.

Stakeholders' perception of factors influencing adoption of a pediatric weight management intervention: a qualitative study.

Background: Childhood obesity is highly prevalent in the United States and disproportionately impacts communities of color and low-income populations; these disparities have worsened during the COVID-19 pandemic. Adoption of effective pediatric weight management interventions (PWMIs) that have been evaluated among low-income diverse populations is needed. The Healthy Weight Clinic PWMI, a package co-developed by the American Academy of Pediatrics and Massachusetts General Hospital, helps health centers establish multidisciplinary Healthy Weight Clinics based on previous randomized controlled trials which demonstrated effectiveness. We sought to identify the factors influencing successful adoption of this PWMI and understand adaptations needed prior to implementation in new sites. Methods: We interviewed 20 stakeholders, 10 from two health centers in Mississippi where the Healthy Weight Clinic PWMI will be piloted (pre-implementation sites) and 10 from health centers that have previously implemented it (sites in maintenance stages). Separate interview guides informed by the Consolidated Framework for Implementation Research (CFIR) were developed for the pre-implementation sites and those in maintenance stages, including questions related to adaptations of the PWMI in response to the COVID-19 pandemic. Qualitative data analysis was conducted using directed content analysis based on CFIR constructs. Adaptations in response to the pandemic were categorized using Framework for Reporting Adaptations and Modifications-Expanded (FRAME). Results: In pre-implementation sites, an inner setting facilitator mentioned was a positive learning climate. Characteristics of individuals that can facilitate adoption include staff willingness to learn, valuing evidence-based care for childhood obesity, and culturally and weight-sensitive staff. In terms of patient needs and resources (outer setting), social drivers of health are barriers to adoption, but creative solutions were suggested to mitigate these. Other facilitators related to the intervention included its multidisciplinary model and adaptability. Similar themes were elicited from sites in maintenance stages; adaptations brought on by the pandemic, such as telehealth visits and content modification to align with distancing guidelines and the effects of social isolation were also described. Conclusion: Understanding the factors influencing adoption of an evidence-based PWMI informs necessary adaptations and implementation strategies required to facilitate nationwide dissemination of PWMIs, with the goal of reaching the populations most at-risk.

Adapting Connect for Health pediatric weight management program for telehealth in response to the COVID-19 pandemic.

BACKGROUND: To address the evolving needs and context changes due to the COVID-19 pandemic, we adapted Connect for Health, an evidence-based, primary care, pediatric weight management intervention. The objective of this study is to describe the planned adaptation process to ensure continued and equitable program uptake during the pandemic. METHODS: Guided by adaptation frameworks, we identified the core functions and forms of Connect for Health and then adapted the intervention in response to a changing healthcare context. We engaged stakeholders and surveyed parents of children with a BMI ≥ 85th percentile and pediatric clinicians and examined their experiences using telehealth for pediatric weight management and needs and preferences. Using multivariable logistic regression, we examined the preferences of parents with limited English proficiency regarding key aspects of pediatric weight management. RESULTS: We surveyed 200 parents and 43% had a primary language of Spanish. Parents wanted care to be a combination of in-person and virtual visits (80%). We found that parents with limited English proficiency had a higher odds ratio of affirming in-person visits are better than virtual visits for ensuring their child's health concern can be taken care of (OR: 2.91; 95% CI: 1.36, 6.21), feeling comfortable when discussing personal information (OR: 3.91; 95% CI: 1.82, 8.43), talking about healthy behaviors and setting goals (OR: 3.09; 95% CI: 1.39, 6.90), and talking about mental health and overall well-being (OR: 4.02; 95% CI: 1.83, 8.87) than parents without limited English proficiency. We surveyed 75 clinicians and 60% felt telehealth was a useful tool to provide care for pediatric weight management. Clinicians felt virtual visits did not pose barriers to all aspects of care. Informed by the surveys and stakeholder input, we made clinician- and family-level adaptations while retaining the program's function. CONCLUSIONS: By engaging stakeholders and adapting the program for telehealth, we optimized the reach and fit of Connect for Health to ensure its continued uptake. We have provided a real-world example of how clinical innovations can evolve and how to systematically plan adaptations in response to changing healthcare contexts. TRIAL REGISTRATION: Clinicaltrials.gov (NCT04042493), Registered on August 2, 2019.

Effects of a Pediatric Weight Management Intervention on Parental Stress.

Background: Few studies have examined the associations of pediatric weight management interventions (PWMIs) with reduction in parental stress. We sought to examine the extent to which a PWMI reduces parental stress and whether changes in parental healthful feeding practices and support for physical activity are associated with reduction in parental stress. Methods: We analyzed data from the Clinic and Community Approaches to Healthy Weight randomized controlled trial (RCT). Parental stress change over 12 months was analyzed using a multivariate mixed linear model. We then examined associations of changes in healthful feeding practices and support for physical activity over 12 months with changes in stress using a multivariate linear model. Results: In multivariate-adjusted models, participation in a PWMI was associated with decrease in parental stress at 12 months, with a mean difference (MD) of -0.24 U [95% confidence interval (CI): -0.45, -0.04]. Increases in scores for exercising regularly [MD = -0.27 (95% CI: -0.52, -0.03)] and keeping healthy food at home [MD = -0.38 (95% CI: -0.66, -0.10)] were associated with decrease in stress. Conclusions: Participation in a PWMI was associated with decrease in parental stress. Encouraging parents of children with overweight and obesity to keep healthy food in the house and exercise regularly may represent important strategies to improve parental stress. PWMI effectiveness studies should consider parental stress as an outcome while addressing social determinants of health that may influence parental stress. Clinical Trial Registration Number: NCT03012126.