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Background: There have been mixed findings on the relationships between childhood obesity and macroscale retail food environments. The current study investigates associations of the neighborhood retail food environment with changes in children's weight status over 6 years in the Kansas City Metropolitan area. Methods: Anthropometrics and home addresses were collected during routine well-child visits in a large pediatric hospital (n = 4493; >75% were Black or Latinx children). Children had measures collected during two time periods ([Time 1] 2012-2014, [Time 2] 2017-2019). Establishment-level food environment data were used to determine the number of four types of food outlets within a 0.5-mile buffer from the children's residence: supermarkets/large grocery stores, convenience stores/small grocery stores, limited-service restaurants, and full-service restaurants. Children who moved residences between periods were "movers" (n = 1052). Associations of baseline and changes in food environment status with Time 2 weight status were assessed using mixed-effects models. Results: Movers who experienced no change in the number of convenience stores or small grocery stores within a 0.5-mile of their home had increased likelihoods of having overweight/obesity and less favorable BMIz changes, compared with movers who experienced a decrease in convenience stores/small grocery stores within a 0.5-mile distance. No associations were observed among nonmovers. Conclusion: Findings suggest that moving to an area with fewer unhealthy retail food outlets (e.g., convenience stores) is associated with a lower risk of obesity in children. Future research is needed to determine whether larger-scale changes to the retail food environment within a neighborhood can support children's healthy weight.
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OBJECTIVE: The purpose of this systematic review and meta-analysis was to examine the effectiveness of psychological interventions at improving physical or mental health outcomes for youth living in rural communities who have, or are at-risk for, any chronic medical condition in comparison to control interventions conducted in rural communities. METHODS: Following prospective registration (OSF.IO/7TDQJ), 7 databases were searched through July 1, 2023. Studies were included if they were a randomized control trial of a psychological intervention conducted with youth living in a rural area who had, or were at-risk for, a chronic medical condition. Risk of bias was assessed with the Cochrane risk of bias version 2 tool. A qualitative synthesis and meta-analysis were conducted. RESULTS: 15 studies met inclusion criteria. Obesity studies (n = 13) primarily focused on body mass index metrics, with limited significant findings across studies. Asthma treatment interventions (n = 2) showed no impact on hospitalizations. 3 studies evaluated mental health outcomes with no significant group differences observed. We meta-analytically analyzed 9 studies that evaluated body mass index z-scores and identified an overall null effect (Hedge's g = 0.01, 95% CI [-0.07, 0.09], p = .85). CONCLUSIONS: Most included studies focused on pediatric obesity, and there was a limited range of health outcomes reported. Compared to controls, minimal significant improvements in health outcomes were identified for psychological interventions for youth living in rural communities. Future efforts may benefit from situating this work more systematically within a health disparities framework with a focus on understanding mechanisms of disparities and translating this work into interventions and policy changes.
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BACKGROUND: Thers is limited research examining modifiable cardiometabolic risk factors with a single-item health behavior question obtained during a clinic visit. Such information could support clinicians in identifying patients at risk for adverse cardiometabolic health. We investigated if children meeting physical activity or screen time recommendations, collected during clinic visits, have better cardiometabolic health than children not meeting recommendations. We hypothesized that children meeting either recommendation would have fewer cardiometabolic risk factors. METHODS AND FINDINGS: This cross-sectional study used data from electronic medical records (EMRs) between January 1, 2013 through December 30, 2017 from children (2-18 years) with a well child visits and data for ≥1 cardiometabolic risk factor (i.e., systolic and diastolic blood pressure, glycated hemoglobin, alanine transaminase, high-density and low-density lipoprotein, total cholesterol, and/or triglycerides). Physical activity and screen time were patient/caregiver-reported. Analyses included EMRs from 63,676 well child visits by 30,698 unique patients (49.3% female; 41.7% Black, 31.5% Hispanic). Models that included data from all visits indicated children meeting physical activity recommendations had reduced risk for abnormal blood pressure (odds ratio [OR] = 0.91, 95%CI 0.86, 0.97; p = 0.002), glycated hemoglobin (OR = 0.83, 95%CI 0.75, 0.91; p = 0.00006), alanine transaminase (OR = 0.85, 95%CI 0.79, 0.92; p = 0.00001), high-density lipoprotein (OR = 0.88, 95%CI 0.82, 0.95; p = 0.0009), and triglyceride values (OR = 0.89, 95%CI 0.83, 0.96; p = 0.002). Meeting screen time recommendations was not associated with abnormal cardiometabolic risk factors. CONCLUSION: Collecting information on reported adherence to meeting physical activity recommendations can provide clinicians with additional information to identify patients with a higher risk of adverse cardiometabolic health.
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Fatores de Risco Cardiometabólico , Exercício Físico , Humanos , Feminino , Masculino , Adolescente , Criança , Estudos Transversais , Pré-Escolar , Registros Eletrônicos de Saúde/estatística & dados numéricos , Pressão Sanguínea , Hemoglobinas Glicadas/análise , Hemoglobinas Glicadas/metabolismo , Doenças Cardiovasculares/epidemiologia , Tempo de Tela , Fatores de Risco , Alanina Transaminase/sangue , Alanina Transaminase/metabolismo , Triglicerídeos/sangueRESUMO
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.
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Terapia Baseada em Transplante de Células e Tecidos , Imunoterapia , Humanos , Terapia Baseada em Transplante de Células e Tecidos/normas , Terapia Baseada em Transplante de Células e Tecidos/métodos , Imunoterapia/efeitos adversos , Imunoterapia/legislação & jurisprudência , Imunoterapia/métodos , Ensaios Clínicos como Assunto/legislação & jurisprudência , Farmacovigilância , Vigilância de Produtos ComercializadosRESUMO
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).
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Obesidade Infantil , Humanos , Criança , Peso Corporal , Obesidade Infantil/diagnóstico , População Rural , Estatura , Índice de Massa Corporal , Atenção Primária à SaúdeRESUMO
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.
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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.
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Obesidade Infantil , Criança , Humanos , Adolescente , Obesidade Infantil/epidemiologia , Obesidade Infantil/prevenção & controle , População Rural , Índice de Massa Corporal , Comportamentos Relacionados com a Saúde , Promoção da Saúde/métodosRESUMO
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.
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Obesidade Infantil , Telemedicina , Criança , Humanos , Obesidade Infantil/epidemiologia , Obesidade Infantil/prevenção & controle , População Rural , Pais , Características da FamíliaRESUMO
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.
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Saúde Mental , Pais , Feminino , Humanos , Masculino , Prevalência , Estudos Retrospectivos , Pais/psicologia , Mães/psicologia , Pai/psicologiaRESUMO
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.
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Saúde da Criança , Alimentos , Humanos , Criança , Estudos Transversais , Programas Governamentais , Nível de SaúdeRESUMO
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.
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Obesidade Infantil , Humanos , Feminino , Criança , Índice de Massa Corporal , Projetos de Pesquisa , EstudantesRESUMO
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.
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Obesidade Infantil , População Rural , Humanos , Dieta , Índice de Massa Corporal , Pais , Obesidade Infantil/terapiaRESUMO
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.
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Distinções e Prêmios , Pesquisa Biomédica , Estados Unidos , Criança , Humanos , Feminino , Psicologia da Criança , Pesquisadores , National Institutes of Health (U.S.) , MentoresRESUMO
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.
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Nutrição Enteral , Comportamento Alimentar , Criança , Humanos , Desmame , Estudos Prospectivos , Nutrição Enteral/métodosRESUMO
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.
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COVID-19 , Obesidade Infantil , Criança , Humanos , Feminino , Masculino , Pandemias , Saúde da Criança , COVID-19/epidemiologia , Comportamentos Relacionados com a Saúde , PaisRESUMO
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.
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Gastos em Saúde , Obesidade Infantil , Estados Unidos , Humanos , Criança , Medicaid , Estudos Retrospectivos , Estudos Transversais , Doença CrônicaRESUMO
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.
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Sobrepeso , População Rural , Feminino , Estados Unidos , Humanos , Criança , Índice de Massa Corporal , Obesidade , Atenção Primária à SaúdeRESUMO
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.