Development of a Safety Surveillance Plan for the Academic Medicine Sponsor Performing First-in-Human Cellular Therapy Clinical Trials: A Report from the Consortium for Pediatric Cellular Immunotherapy.

Pharmacovigilance (PV), also known as drug safety, is the science of risk management involving the detection, assessment, understanding, and prevention of adverse effects related to a medication. This discipline has traditionally focused on the postmarketing period, with less attention to early-phase clinical trials. However, during the immunotherapy and cellular therapy investigational stage, regulatory agencies are increasingly emphasizing the need to identify and characterize safety signals earlier in clinical development as part of a comprehensive safety surveillance plan. Compliance with PV and safety regulations are further heightened as cell and gene therapy (CGT) trials grow in complexity and scope owing to ever-changing and increasingly rigorous regulatory mandates. Based on this changing landscape, a critical aspect of early-phase trials of cellular products where significant safety events are anticipated is to ensure that every effort is made to protect clinical trial participants by maximizing attention to the risk-versus-benefit profile. This includes the development of robust plans for safety surveillance that provide a continual assessment of safety signals to enable safety reporting to regulatory bodies and the Food and Drug Administration, a regular analysis of aggregate safety data, and a plan to communicate safety findings. This report focuses on PV in early-phase clinical trials of first-in-human investigational products sponsored by academic centers in which the availability of PV resources and subject matter experts is limited. To more fully understand the challenges of CGT PV oversight within pediatric academic medical centers conducting early-phase clinical trials, a working group from institutions participating in the Consortium for Pediatric Cellular Immunotherapy composed of faculty and regulatory professionals was convened to compare experiences, identify best practices, and review published literature to identify commonalities and opportunities for alignment. Here we present guidelines on PV planning in early-phase CGT clinical trials occurring in academic medical centers and offer strategies to mitigate risk to trial participants. Standards to address regulatory requirements and governance for safety signal identification and risk assessment are discussed.

Validation of remote anthropometric measurements in a rural randomized pediatric clinical trial in primary care settings.

Rural children are more at risk for childhood obesity but may have difficulty participating in pediatric weight management clinical trials if in-person visits are required. Remote assessment of height and weight observed via videoconferencing may provide a solution by improving the accuracy of self-reported data. This study aims to validate a low-cost, scalable video-assisted protocol for remote height and weight measurements in children and caregivers. Families were provided with low-cost digital scales and tape measures and a standardized protocol for remote measurements. Thirty-three caregiver and child (6-11 years old) dyads completed remote (at home) height and weight measurements while being observed by research staff via videoconferencing, as well as in-person measurements with research staff. We compared the overall and absolute mean differences in child and caregiver weight, height, body mass index (BMI), and child BMI adjusted Z-score (BMIaz) between remote and in-person measurements using paired samples t-tests and one sample t-tests, respectively. Bland-Altman plots were used to estimate the limits of agreement (LOA) and assess systematic bias. Simple regression models were used to examine associations between measurement discrepancies and sociodemographic factors and number of days between measurements. Overall mean differences in child and caregiver weight, height, BMI, and child BMIaz were not significantly different between remote and in-person measurements. LOAs were - 2.1 and 1.7 kg for child weight, - 5.2 and 4.0 cm for child height, - 1.5 and 1.7 kg/m2 for child BMI, - 0.4 and 0.5 SD for child BMIaz, - 3.0 and 2.8 kg for caregiver weight, - 2.9 and 3.9 cm for caregiver height, and - 2.1 and 1.6 kg/m2 for caregiver BMI. Absolute mean differences were significantly different between the two approaches for all measurements. Child and caregiver age were each significantly associated with differences between remote and in-person caregiver height measurements; there were no significant associations with other measurement discrepancies. Remotely observed weight and height measurements using non-research grade equipment may be a feasible and valid approach for pediatric clinical trials in rural communities. However, researchers should carefully evaluate their measurement precision requirements and intervention effect size to determine whether remote height and weight measurements suit their studies.Trial registration: ClinicalTrials.gov NCT04142034 (29/10/2019).

Barriers to Participation in a Telemedicine-based, Family-based Behavioral Group Treatment Program for Pediatric Obesity: Qualitative findings from Rural Caregivers.

This study examined factors influencing rural caregivers' decision to decline participation in a healthy lifestyle intervention. Eligible caregivers of rural children who declined participation in a healthy lifestyle intervention were interviewed regarding reasons for declining. Inductive thematic analyses were conducted for responses. Caregiver interviews (n=16) resulted in 5 saturated themes: (1) rural families' household schedules prohibit participation, (2) preference for diverse treatment approaches, (3) desire for information across multimedia platforms, and more communication with a point-of-contact, (4) support for an inclusive approach integrated with existing school practices, and (5) caregivers had an understanding of behaviors that promote health.

Effectiveness of a paediatric weight management intervention for rural youth (iAmHealthy): Primary outcomes of a cluster randomised control trial.

BACKGROUND: Youth in rural areas are disproportionally affected by obesity. Given the unique barriers rural populations face, tailoring and increasing access to obesity interventions is necessary. OBJECTIVE: This paper evaluates the effectiveness of iAmHealthy, a family-based paediatric obesity intervention delivered to rural children, compared to a Newsletter Control. METHODS: Participating schools (n = 18) were randomly assigned to iAmHealthy or Newsletter Control. iAmHealthy consists of individual health coaching and group sessions delivered via televideo to a participant's home. The child and parent's body mass index (BMI), child physical activity and child dietary intake were assessed at baseline, post-treatment (8 months) and follow-up (20 months). Multilevel modeling estimated the effect of treatment at both time points. RESULTS: Parent and child dyads were recruited (n = 148) and randomised to iAmHealthy (n = 64) or the Control group (n = 84). The Control group had significant increases in child BMIz from baseline to follow-up. iAmHealthy youth had no significant changes in BMIz from baseline to post or follow-up. Child dietary intake, physical activity and parent BMI results are also discussed. CONCLUSIONS: This trial extends previous paediatric obesity work by simultaneously increasing convenience and dose of treatment. Results suggest iAmHealthy resulted in a change in BMIz trajectories and long-term health behaviour for youth.

Rural Family Satisfaction With Telehealth Delivery of an Intervention for Pediatric Obesity and Associated Family Characteristics.

Objective: To describe satisfaction with the telehealth aspect of a pediatric obesity intervention among families from multiple rural communities and assess differences in satisfaction based on sociodemographic factors. Methods: This is a secondary analysis of data from a pilot randomized controlled trial of a 6-month intensive lifestyle intervention (iAmHealthy) delivered through telehealth to children 6-11 years old with BMI ≥85th%ile and their parents from rural communities. Parents completed a sociodemographic survey and a validated survey to assess satisfaction with the telehealth intervention across four domains (technical functioning, comfort of patient and provider with technology and perceived privacy, timely and geographic access to care, and global satisfaction) on a 5-point Likert scale. Kruskal-Wallis nonparametric rank test were used to compare mean satisfaction scores based on parent sociodemographics. Results: Forty-two out of 52 parents (67% White, 29% Black, 5% multiracial, and 50% with household income <$40,000) completed the survey. Mean satisfaction scores ranged from 4.16 to 4.54 (standard deviation 0.44-0.61). Parents without a college degree reported higher satisfaction across all domains compared with parents with a college degree, including global satisfaction (mean 4.64 vs. 4.31, p = 0.03). Parents reporting a household income <$40,000 (mean 4.70) reported higher scores in the comfort with technology and perceived privacy domain compared with parents with higher incomes (mean 4.30-4.45, p = 0.04). Discussion: Parents from rural communities, especially those from lower socioeconomic backgrounds, were highly satisfied with the iAmHealthy telehealth intervention. These findings can be used to inform future telehealth interventions among larger more diverse populations. ClinicalTrials.gov Identifier: NCT04142034.

Prevalence of Parent Mental Health Problems in an Interdisciplinary Feeding Clinic: Short Communication.

Parents of children with pediatric feeding disorder (PFD) often experience high stress and may be at advanced risk for mental health conditions. We conducted a retrospective chart review of 413 parents who completed intake surveys at an interdisciplinary feeding clinic to determine the prevalence and types of mental health conditions among parents; 41.8% of parents reported a mental health diagnosis among the mother and/or father. Of the parents with mental health conditions, the most prevalent conditions reported were anxiety (71.1% for mothers, 50% for fathers) and mood disorders (62.7% for mothers, 40.9% for fathers). For mothers, 21.1% indicated their mental health disorder had a postpartum onset. Parents of children with birth complications were more likely to have a mental health condition (50.9%) than parents of children without a birth complication (38.7%), and parents reporting mental health conditions had children with significantly more co-occurring medical conditions. Since parent stress and mental health can influence parent-child interactions during mealtime, this study suggests the importance of addressing both parent mental health factors and child factors when treating children for PFD. Future studies are needed to develop novel interventions that support the specific mental health needs of parents of children with PFD.

Prospective associations of neighborhood healthy food access and walkability with weight status in a regional pediatric health system.

BACKGROUND: Most neighborhood food and activity related environment research in children has been cross-sectional. A better understanding of prospective associations between these neighborhood environment factors and children's weight status can provide stronger evidence for informing interventions and policy. This study examined associations of baseline and changes in neighborhood healthy food access and walkability with changes in children's weight status over 5 years. METHODS: Height, weight, and home address were obtained for 4,493 children (> 75% were Black or Latinx) from primary care visits within a large pediatric health system. Eligible participants were those who had measures collected during two time periods (2012-2014 [Time 1] and 2017-2019 [Time 2]). Data were integrated with census tract-level healthy food access and walkability data. Children who moved residences between the time periods were considered 'movers' (N = 1052; 23.4%). Mixed-effects models, accounting for nesting of children within census tracts, were conducted to model associations of baseline and changes in the neighborhood environment variables with Time 2 weight status (BMIz and overweight or obese vs. healthy weight). Models adjusted for weight status and child and neighborhood sociodemographics at baseline. RESULTS: Children living in a neighborhood with [ample] healthy food access at Time 1 had a lower BMIz at Time 2, regardless of mover status. A decrease in healthy food access was not significantly associated with children's weight status at Time 2. Baseline walkability and improvements in walkability were associated with a lower BMIz at Time 2, regardless of mover status. CONCLUSIONS: Findings provide evidence that residing in a neighborhood with healthy food access and walkability may support a healthy weight trajectory in children. Findings on changes in the neighborhood environment suggested that improved walkability in the neighborhood may support children's healthy weight. The greater and more consistent findings among movers may be due to movers experiencing greater changes in neighborhood features than the changes that typically occur within a neighborhood over a short period of time. Future research is needed to investigate more robust environmental changes to neighborhoods.

Recruitment and reach in a school-based pediatric obesity intervention trial in rural areas.

Introduction: The purpose of this study is to evaluate two recruitment strategies on schools and participant participation rates and representativeness (reach) within a pediatric obesity treatment trial tailored for families who live in rural areas. Methods: Recruitment of schools was evaluated based on their progress toward enrolling participants. Recruitment and reach of participants were evaluated using (1) participation rates and (2) representativeness of demographics and weight status of participants compared to eligible participants (who did not consent and enroll) and all students (regardless of eligibility). School recruitment, as well as participant recruitment and reach, were evaluated across recruitment methods comparing opt-in (i.e., caregivers agreed to allow their child to be screened for eligibility) vs. screen-first (i.e., all children screened for eligibility). Results: Of the 395 schools contacted, 34 schools (8.6%) expressed initial interest; of these, 27 (79%) proceeded to recruit participants, and 18 (53%) ultimately participated in the program. Of schools who initiated recruitment, 75% of schools using the opt-in method and 60% of schools using the screen-first method continued participation and were able to recruit a sufficient number of participants. The average participation rate (number of enrolled individuals divided by those who were eligible) from all 18 schools was 21.6%. This percentage was higher in schools using the screen-first method (average of 29.7%) compared to schools using the opt-in method (13.5%). Study participants were representative of the student population based on sex (female), race (White), and eligibility for free and reduced-price lunch. Study participants had higher body mass index (BMI) metrics (BMI, BMIz, and BMI%) than eligible non-participants. Conclusions: Schools using the opt-in recruitment were more likely to enroll at least 5 families and administer the intervention. However, the participation rate was higher in screen-first schools. The overall study sample was representative of the school demographics.

Rationale and design of integrating a parents first obesity intervention with a pediatric weight management intervention for rural families - Evaluating the ripple effect.

Rural families are disproportionately affected by obesity. Obesity often runs in families and is impacted by hereditary components, the shared home environment, and parent modeling/child observational learning. Moreover, parent changes in weight predict child changes in weight. Thus, targeting the family unit has the potential to enhance outcomes for adults and children simultaneously. Additionally, engaging rural nurses in medical clinics and schools may be important in determining whether rural telehealth programs are successfully implemented and sustained. This paper describes the rationale and design of a randomized control trial (RCT) evaluating the effectiveness of an integrated adult- and child-focused obesity treatment tailored for rural participants. Outcomes of this study include participant weight loss from baseline to 9-months, device-measured physical activity, and dietary intake. This project will additionally compare reach between clinic and school settings and evaluate the impact of nurse engagement. This study will include 240 participants from eight rural communities who will be randomized to either a Parent +Family-based group or a Newsletter +Family-based group. Parents in the Parent +Family-based group will receive a 3-month adult obesity treatment designed for adult behavior change as a first step. Then, parents and children together will enter the family-based program (iAmHealthy), allowing for potential enhancement of a theorized ripple effect. Parents in the Newsletter +Family-based group will receive 3 monthly newsletters and then participate in the 6-month family-based intervention designed for child behavior change. This study is the first RCT to examine the effectiveness of an integrated adult- and child-focused obesity treatment program. Registered with ClinicalTrials.gov NCT ID NCT05612971.

Pediatric Tube Weaning: A Meta-Analysis of Factors Contributing to Success.

Approximately 3-10% of children have severe feeding issues, and some require enteral/tube nutrition to grow and thrive. For many children, tube feeding is temporary, making efficacious interventions for tube weaning essential. We conducted a systematic review and meta-analysis of tube weaning treatments. Outcomes included percentage of participants completely weaned from the tube, and mean percentage of kilocalories consumed orally following treatment. Data were extracted from 42 studies, including cohort studies and single-subject research design studies. We evaluated moderators of treatment success, including treatment setting, use of behavioral approaches, use of hunger provocation, and use of a multidisciplinary approach. Results indicated that, after treatment, children received significantly more calories orally, and 67-69% of children were fully weaned. These analyses suggest that current interventions are generally effective; however, variability within treatments exist. Prospective randomized clinical trials are needed to understand effective components of weaning interventions.

Addressing Barriers to Career Development Awards for Early Career Women in Pediatric Psychology.

OBJECTIVE: To provide person and system-level recommendations for supporting early career women in the field of pediatric psychology in writing and submitting National Institutes of Health (NIH) Career Development Award (K award) applications. Recommendations are provided in the context of common barriers, with a focus on practical solutions. METHODS: Publicly available NIH reporter data were compiled to examine rates of funding for Society of Pediatric Psychology (SPP) members. Barriers that women face when initiating programs of research are described and applied to the field of pediatric psychology. RESULTS: Of current SPP members, 3.9% (n = 50) have ever received an NIH K award. Approximately 88.5% of SPP members identify as women, including 89.0% of SPP K award recipients. A table of person- and systems-level recommendations is provided to offer strategies for mentees, mentors/sponsors, institutions, and national organizations to address the barriers discussed. CONCLUSIONS: By addressing gender-specific barriers to submitting K award applications, we hope to increase the number of women K awardees and support the scientific advancement of pediatric psychology.

Sociodemographic Variation in Children's Health Behaviors During the COVID-19 Pandemic.

Background: Societal changes during the COVID-19 pandemic may affect children's health behaviors and exacerbate disparities. This study aimed to describe children's health behaviors during the COVID-19 pandemic, how they vary by sociodemographic characteristics, and the extent to which parent coping strategies mitigate the impact of pandemic-related financial strain on these behaviors. Methods: This study used pooled data from 50 cohorts in the Environmental influences on Child Health Outcomes Program. Children or parent proxies reported sociodemographic characteristics, health behaviors, and parent coping strategies. Results: Of 3315 children aged 3-17 years, 49% were female and 57% were non-Hispanic white. Children of parents who reported food access as a source of stress were 35% less likely to engage in a higher level of physical activity. Children of parents who changed their work schedule to care for their children had 82 fewer min/day of screen time and 13 more min/day of sleep compared with children of parents who maintained their schedule. Parents changing their work schedule were also associated with a 31% lower odds of the child consuming sugar-sweetened beverages. Conclusions: Parents experiencing pandemic-related financial strain may need additional support to promote healthy behaviors. Understanding how changes in parent work schedules support shorter screen time and longer sleep duration can inform future interventions.

Medicaid Expenditures among Children with Documented Obesity.

Background: Obesity rates continue to rise among children, but knowledge regarding medical expenditures of Medicaid enrollees with documented obesity is lacking. We aim to describe Medicaid expenditure patterns among children with documented obesity and determine the degree to which specific clinical characteristics and conditions contribute to high expenditures. Methods: We performed a retrospective cross-sectional analysis of children aged 2-17 years with a diagnosis code of obesity continuously enrolled in the 2017 Medicaid MarketScan database. Children were grouped based on annual expenditure percentiles: <80th, 80 to <95th, 95 to <99th, and ≥99th. Inpatient, outpatient, and pharmacy expenditures were analyzed. Covariates included demographics, common obesity comorbid conditions (e.g., hypertension), complex chronic conditions (CCCs), and mental health conditions (MHCs). Logistic regression assessed demographic and clinical characteristics associated with high-spending groups (≥95th%). Results: We identified 300,286 children with a diagnosis of obesity. The 1% of children with the highest spending accounted for 25.4% of annual expenditures among children with documented obesity. Annual expenditures in the highest spending groups were driven primarily by inpatient and outpatient mental health services. Characteristics associated with high-spending groups included the following: age 12-17 years, obesity comorbid conditions, and having ≥1 CCC or MHC. These associations increased with increasing number of CCCs or MHCs. Conclusions: Inpatient and outpatient mental health expenditures made up a large proportion of spending among Medicaid-enrolled children with documented obesity. Important drivers of cost in this population were medical complexity and comorbid MHCs. Future research is needed to determine if some of these costs are avoidable in children with obesity.

Active vs Traditional Methods of Recruiting Children for a Clinical Trial in Rural Primary Care Clinics: A Cluster-Randomized Clinical Trial.

Importance: To our knowledge, there are no published randomized clinical trials of recruitment strategies. Rigorously evaluated successful recruitment strategies for children are needed. Objective: To evaluate the feasibility of 2 recruitment methods for enrolling rural children through primary care clinics to assess whether either or both methods are sufficiently effective for enrolling participants into a clinical trial of a behavioral telehealth intervention for children with overweight or obesity. Design, Setting, and Participants: This cluster-randomized clinical trial of 2 recruitment methods was conducted at 4 primary care clinics in 4 separate states. Each clinic used both recruitment methods in random order. Clinic eligibility criteria included at least 40% pediatric patients with Medicaid coverage and at least 100 potential participants. Eligibility criteria for children included a rural home address, age 6 to 11 years, and body mass index at or above the 85th percentile. Recruitment began February 3, 2020, and randomization of participants occurred on August 17, 2020. Data were analyzed from October 3, 2021, to April 21, 2022. Interventions: Two recruitment methods were assessed: the active method, for which a list of potential participants seen within the past year at each clinic was generated through the electronic health record and consecutively approached by research staff based on visit date to the clinic, and the traditional method, for which recruitment included posters, flyers, social media, and press release. Clinics were randomized to the order in which the 2 methods were implemented in 4-week periods, followed by a 4-week catch-up period using the method found most effective in previous periods. Main Outcomes and Measures: For each recruitment method, the number and proportion of randomized children among those who were approached was calculated. Results: A total of 104 participants were randomized (58 girls [55.8%]; mean age, 9.3 [95% CI, 9.0-9.6] years). Using the active method, 535 child-parent dyads were approached and 99 (18.5% [95% CI, 15.3%-22.1%]) were randomized. Using the traditional method, 23 caregivers expressed interest, and 5 (21.7% [95% CI, 7.5%-43.7%]) were randomized. All sites reached full enrollment using the active method and no sites achieved full enrollment using the traditional method. Mean time to full enrollment was 26.3 (range, 21.0-31.0) days. Conclusions and Relevance: This study supports the use of the active approach with local primary care clinics to recruit children with overweight and obesity from rural communities into clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT04142034.

Telemedicine utilization and perceived quality of virtual care among pregnant and postpartum women during the COVID-19 pandemic.

INTRODUCTION: The aim of this research was to examine the association between perceived quality of care during the COVID-19 pandemic and the modality of maternity care visits, virtual or in-person. METHODS: This study utilized an online nationwide survey about experiences in prenatal and postpartum care between 18 April and 6 August 2020. Perceived quality of care was categorized into worse care, better, or the same care as compared to before the pandemic. Barriers were categorized into five groups: (1) concern for the privacy of health information, (2) not having a private or quiet place, (3) lack of physical exam or measurements, (4) quality of care, and (5) technology issues. Data analyses included bivariate analyses and multivariate logistic regression. RESULTS: The majority (75.3%) of modified visits utilized telemedicine. Over half of the women took at-home measurements and the majority were successful. Barriers to care included a lack of a quiet or private space to conduct their visit. Women expressed concerns about a lack of measurements and a lower quality of care. Women who received telemedicine visits perceived worse care as compared to women who received in-person care visits (OR = 5.62; 95% CI 5.01-6.31). DISCUSSION: Previous studies have shown that pregnant patients are generally satisfied with virtual care during the pandemic. This study provides insight from a large nationwide sample of women and geographic variation in satisfaction and perceived quality. These findings highlight barriers and potential solutions to improving patients' perceived quality of virtual maternity care, and thus future uptake of high-quality, virtual care.

The impact of COVID-19 on rural treatment-seeking families with children with overweight or obesity.

To examine the early impact of the COVID-19 pandemic on rural parental stress and family behaviors, parents who participated in a 2nd-4th grade pediatric obesity intervention completed a survey in May 2020. Parents (N=77) experienced 7.8±2.7 events on the COVID-19 Exposure and Family Impact Scales (CEFIS) with an average impact of 2.5±0.5, with many parents reporting moderate stress (73%). Parental stress was predictive of personal well-being getting 'worse' while loss of income events were predictive of family routines getting 'better.' Professionals working with rural families may want to assess for these factors when promoting positive changes in family health behaviors.

Conducting a pediatric randomized clinical trial during a pandemic: A shift to virtual procedures.

Background/Objective: Prior to the COVID-19 pandemic, our research group initiated a pediatric practice-based randomized trial for the treatment of childhood obesity in rural communities. Approximately 6 weeks into the originally planned 10-week enrollment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment, enrollment, and other study methods in order to complete the trial using virtual procedures. This descriptive paper outlines methods used to recruit, enroll, and manage clinical trial participants with technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial. Methods: The study team reviewed the IRB records, protocol team meeting minutes and records, and surveyed the site teams to document the impact of the COVID-19 shift to virtual procedures on the study. The IRB approved study changes allowed for flexibility between clinical sites given variations in site resources, which was key to success of the implementation. Results: All study sites faced a variety of logistical challenges unique to their location yet successfully recruited the required number of patients for the trial. Ultimately, virtual procedures enhanced our ability to establish relationships with participants who were previously beyond our reach, but presented several challenges and required additional resources. Conclusion: Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with rural and underserved populations or during challenging events like the pandemic.

The Impact of the COVID-19 Pandemic on Healthy Lifestyles in Rural Families.

The purpose of the current study is to understand how the early portion of COVID-19 pandemic impacted the health behaviors of rural families participating in a healthy lifestyles intervention. Caregivers of rural children participating in a healthy lifestyles intervention were invited to participate in a structured interview regarding how the COVID-19 pandemic affected their family and family health behaviors. Interviews were transcribed and the research team conducted a rigorous inductive thematic analysis. Structured qualitative interviews with caregivers (n=30) resulted in 5 saturated themes: (a) caregivers reported new or exacerbated mental health concerns and stress among family members, largely due to social isolation and external stressors, (b) caregivers reported feeling out of control of positive health behaviors for themselves and their children, (c) families reported variability in how they handled reductions in schedule demands, ranging from filling time with positive activities to negative behaviors such as snacking, (d) families continuously re-adjusted their approach to parenting, routines, and health behaviors due to internal and external factors, (e) families ate foods that were accessible and convenient, which impacted the health of the family diet. Despite being asked primarily about lifestyle behavior changes, families reported concerns around mental health. Implications are that professionals working with rural children and families, even those without mental health training, may be called upon to help address these concerns especially in these underserved, rural families.

Validation of remote height and weight assessment in a rural randomized clinical trial.

BACKGROUND: The purpose of this study is to describe and assess a remote height and weight protocol that was developed for an ongoing trial conducted during the SARS COV-2 pandemic. METHODS: Thirty-eight rural families (children 8.3 ± 0.7 years; 68% female; and caregivers 38.2 ± 6.1 years) were provided detailed instructions on how to measure height and weight. Families obtained measures via remote data collection (caregiver weight, child height and weight) and also by trained staff. Differences between data collection methods were examined. RESULTS: Per absolute mean difference analyses, slightly larger differences were found for child weight (0.21 ± 0.21 kg), child height (1.53 ± 1.29 cm), and caregiver weight (0.48 ± 0.42 kg) between school and home measurements. Both analyses indicate differences had only minor impact on child BMI percentile (- 0.12, 0.68) and parent BMI (0.05, 0.13). Intraclass coefficients ranged from 0.98 to 1.00 indicating that almost all of the variance was due to between person differences and not measurement differences within a person. CONCLUSION: Results suggest that remote height and weight collection is feasible for caregivers and children and that there are minimal differences in the various measurement methods studied here when assessing group differences. These differences did not have clinically meaningful impacts on BMI. This is promising for the use of remote height and weight measurement in clinical trials, especially for hard-to reach-populations. TRIAL REGISTRATION: Clinical. Registered in clinicaltrials.gov ( NCT03304249 ) on 06/10/2017.