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

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

Family-Based Telehealth Initiative to Improve Nutrition and Physical Activity for Children With Obesity and Its Utility During COVID-19: A Mixed Methods Evaluation.

Guidelines recommend primary care providers refer children with obesity to behavioral interventions, but given limited program availability, access, and parental engagement, referrals remain rare. We developed telehealth coaching interventions for families whose children received care at a health system in Pennsylvania, United States in 2019-2020. Intervention referrals were facilitated by the pediatrician and/or project team for 6-12-year-old children with obesity following well-child visits. Participants chose one of three 26-week interventions focused on healthy eating, physical activity, or a hybrid clinical/nutrition intervention. Interventions engaged parents as change agents, enhancing self-efficacy to model and reinforce behavior and providing resources to help create a healthy home environment. We enrolled 77 of 183 eligible parent/child dyads. We used mixed methods to evaluate the interventions. Repeated measures models among participants showed significant reductions in obesogenic nutrition behaviors post-intervention and at 1-year follow-up, including a reduction in sugar-sweetened beverage intake of 2.14 servings/week (95% confidence interval: -3.45, -0.82). There were also improvements in obesoprotective nutrition behaviors (e.g., frequency of family meals, parental self-efficacy related to meal management). One year post-baseline, we observed no significant differences in changes in body mass index (BMI) z-scores comparing child participants with matched controls. Given potential impacts of COVID-19 community restrictions on study outcomes, we conducted qualitative interviews with 13 participants during restrictions, which exemplified how disrupted routines constrained children's healthy behaviors but that intervention participation prepared parents by providing cooking and physical activities at home. Findings support the potential of a telehealth-delivered nutrition intervention to support adoption of healthy weight behaviors.

Encouraging appropriate gestational weight gain in high-risk gravida: A randomized controlled trial.

Trial Design: Excessive gestational weight gain (GWG) can increase pregnancy morbidity and is particularly problematic for women with pregestational obesity. A lifestyle modification intervention was introduced to gravida with obesity to decrease excessive GWG as compared to usual care (UC). Methods: A randomized controlled trial was conducted to improve healthy lifestyle behaviors to manage appropriate GWG. Consenting participants with prepregnancy obesity and singletons ≤17 weeks were randomized to (1) Usual Care (UC): usual written educational materials and counseling by obstetric provider or (2) Enhanced Care (EC): UC plus (a) personalized letter from physician detailing appropriate GWG; (b) access to individualized GWG chart; (c) ongoing counseling with registered dietitian/nutritionist (RDN). The primary outcome was proportion with GWG ≤9.1 kg, as this is upper limit recommended by Institute of Medicine (IOM). Total GWG and GWG as less than/within/greater than IOM recommendations (in aggregate and stratified by obesity class), and pregnancy/neonatal outcomes were evaluated as secondary outcomes. Results: Analyses included 105 participants in EC and 109 in UC arms. The groups had similar demographics: 46% with class I obesity, 26% class II, and 28% class III. There were no group differences for any GWG, pregnancy, or neonatal outcomes when analyzed in aggregate. As compared to those randomized to the EC arm, participants in UC arm with class I obesity gained 1.4 kg less and those with class II obesity were significantly more likely to gain within IOM guidelines (14.8% vs. 40.0%, adjusted p = 0.04). Participants with class III obesity randomized to EC arm were more likely to gain within IOM guidelines as compared to participants randomized to UC arm (29.0% vs. 6.7%, adjusted p = 0.02). Conclusion: There were no differences in GWG observed between groups when analyzing participants in aggregate. However, a physician's letter detailing appropriate GWG, patient portal access to a personalized GWG chart, and RDN consultation were helpful for encouraging GWG within IOM guidelines for women with prepregnancy class III obesity. Women with class I or II obesity had better GWG outcomes without these additional interventions.

Advanced Health Information Technologies to Engage Parents, Clinicians, and Community Nutritionists in Coordinating Responsive Parenting Care: Descriptive Case Series of the Women, Infants, and Children Enhancements to Early Healthy Lifestyles for Baby (WEE Baby) Care Randomized Controlled Trial.

BACKGROUND: Socioeconomically disadvantaged newborns receive care from primary care providers (PCPs) and Women, Infants, and Children (WIC) nutritionists. However, care is not coordinated between these settings, which can result in conflicting messages. Stakeholders support an integrated approach that coordinates services between settings with care tailored to patient-centered needs. OBJECTIVE: This analysis describes the usability of advanced health information technologies aiming to engage parents in self-reporting parenting practices, integrate data into electronic health records to inform and facilitate documentation of provided responsive parenting (RP) care, and share data between settings to create opportunities to coordinate care between PCPs and WIC nutritionists. METHODS: Parents and newborns (dyads) who were eligible for WIC care and received pediatric care in a single health system were recruited and randomized to a RP intervention or control group. For the 6-month intervention, electronic systems were created to facilitate documentation, data sharing, and coordination of provided RP care. Prior to PCP visits, parents were prompted to respond to the Early Healthy Lifestyles (EHL) self-assessment tool to capture current RP practices. Responses were integrated into the electronic health record and shared with WIC. Documentation of RP care and an 80-character, free-text comment were shared between WIC and PCPs. A care coordination opportunity existed when the dyad attended a WIC visit and these data were available from the PCP, and vice versa. Care coordination was demonstrated when WIC or PCPs interacted with data and documented RP care provided at the visit. RESULTS: Dyads (N=131) attended 459 PCP (3.5, SD 1.0 per dyad) and 296 WIC (2.3, SD 1.0 per dyad) visits. Parents completed the EHL tool prior to 53.2% (244/459) of PCP visits (1.9, SD 1.2 per dyad), PCPs documented provided RP care at 35.3% (162/459) of visits, and data were shared with WIC following 100% (459/459) of PCP visits. A WIC visit followed a PCP visit 50.3% (231/459) of the time; thus, there were 1.8 (SD 0.8 per dyad) PCP to WIC care coordination opportunities. WIC coordinated care by documenting RP care at 66.7% (154/231) of opportunities (1.2, SD 0.9 per dyad). WIC visits were followed by a PCP visit 58.9% (116/197) of the time; thus, there were 0.9 (SD 0.8 per dyad) WIC to PCP care coordination opportunities. PCPs coordinated care by documenting RP care at 44.0% (51/116) of opportunities (0.4, SD 0.6 per dyad). CONCLUSIONS: Results support the usability of advanced health information technology strategies to collect patient-reported data and share these data between multiple providers. Although PCPs and WIC shared data, WIC nutritionists were more likely to use data and document RP care to coordinate care than PCPs. Variability in timing, sequence, and frequency of visits underscores the need for flexibility in pragmatic studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT03482908; https://clinicaltrials.gov/ct2/show/NCT03482908. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12887-018-1263-z.

A patient-centered, coordinated care approach delivered by community and pediatric primary care providers to promote responsive parenting: pragmatic randomized clinical trial rationale and protocol.

BACKGROUND: Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information technology (HIT) strategies to coordinate care between pediatric primary care providers (PCPs) and the Special Supplemental Nutrition Program for Women, Infant and Children (WIC) community nutritionists to prevent rapid weight gain from birth to 6 months. It is hypothesized that data integration and coordination will improve consistency in RP messaging and parent self-efficacy, promoting shared decision making and infant self-regulation, to reduce infant rapid weight gain from birth to 6 months. METHODS/DESIGN: Two hundred and ninety mothers and their full-term newborns will be recruited and randomized to the "RP intervention" or "standard care control" groups. The RP intervention includes: 1) parenting and nutrition education developed using the American Academy of Pediatrics Healthy Active Living for Families curriculum in conjunction with portions of a previously tested RP curriculum delivered by trained pediatric PCPs and WIC nutritionists during regularly scheduled appointments; 2) parent-reported data using the Early Healthy Lifestyles (EHL) risk assessment tool; and 3) data integration into child's electronic health records with display and documentation features to inform counseling and coordinate care between pediatric PCPs and WIC nutritionists. The primary study outcome is rapid infant weight gain from birth to 6 months derived from sex-specific World Health Organization adjusted weight-for-age z-scores. Additional outcomes include care coordination, messaging consistency, parenting behaviors (e.g., food to soothe), self-efficacy, and infant sleep health. Infant temperament and parent depression will be explored as moderators of RP effects on infant outcomes. DISCUSSION: This pragmatic patient-centered RP intervention integrates and coordinates care across clinical and community sectors, potentially offering a fundamental change in the delivery of pediatric care for prevention and health promotion. Findings from this trial can inform large scale dissemination of obesity prevention programs. TRIAL REGISTRATION: Restrospective Clinical Trial Registration: NCT03482908 . Registered March 29, 2018.

Integrating and coordinating care between the Women, Infants, and Children Program and pediatricians to improve patient-centered preventive care for healthy growth.

New care delivery models call for integrating health services to coordinate care and improve patient-centeredness. Such models have been embraced to coordinate care with evidence-based strategies to prevent obesity. Both the Special Supplemental Program for Women, Infants and Children (WIC) Program and pediatricians are considered credible sources of preventive guidance, and coordinating these independent siloes would benefit a vulnerable population. Using semistructured focus groups and interviews, we evaluated practices, messaging, and the prospect of integrating and coordinating care. Across Pennsylvania, WIC nutritionists (n = 35), pediatricians (n = 15), and parents (N = 28) of an infant or toddler participated in 2016. Three themes were identified: health assessment data sharing (e.g., iron, growth measures), benefits and barriers to integrated health services, and coordinating care to reduce conflicting educational messages (e.g., breastfeeding, juice, introduction of solids). Stakeholders supported sharing health assessment data and integrating health services as strategies to enhance the quality of care, but were concerned about security and confidentiality. Overall, integrated, coordinated care was perceived to be an acceptable strategy to facilitate consistent, preventive education and improve patient-centeredness.