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Patient-clinic-community integration to prevent obesity among rural preschool children
Investigator (PI): Bailey-Davis, Lisa
Performing Organization (PO): (Current): Geisinger, Department of Population Health Sciences / (570) 214-8688
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2020
Final Year: 2024
Record Source/Award ID: PCORI/CER-2019C1-16040
Funding: Total Award Amount: $2,810,726
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Well-child visits (WCV) in primary care clinics provide a sustainable model for intervention delivery, especially since parents and caregivers value and trust feedback from pediatricians. Primary care providers (PCPs) are on the frontlines of obesity prevention, yet clinical preventive care has had limited success in preventing childhood obesity. Nearly all children attend WCV yet obesity rates among preschool-aged children (ages 2-5 years) have escalated and remain high. WCV can be enhanced with patient-reported outcome measures to engage parents and referrals to community services but research has not investigated the comparative effectiveness of these approaches to standard of care WCV. Multilevel approaches have been supported for school-aged children, but evidence is insufficient in providing direction for preschool-aged children. The goal of this research is to respond to this gap by comparing two enhancements to WCV designed to promote family-centered counseling for the prevention of obesity in a high-risk population of rural, lower income preschool-aged children in the Geisinger Health System. The study is responsive to PCORI's focus on high-cost/high-need patients, as rural children experience higher rates of obesity and are nearly twice as likely to experience severe obesity compared to their non-rural counterparts. A cluster-randomized controlled trial is proposed to compare effectiveness of the two enhanced interventions versus the standard WCV on obesity prevention among preschool-aged children. Comparators in the proposed study include the standard of care WCV, the patient-reported outcome (PRO) WCV, and the PRO WCV + Food Care, which represent clinic, patient-clinic, and patient-clinic-community models, respectively. The WCV is consistent with clinical guidelines and the standard annual clinical visit for children in the U.S. The PRO WCV patient-clinic model enhances the ability of clinical providers to quickly assess children's risk of obesity and provide family-centered, behaviorally anchored counseling; and has effectiveness in preventing obesity among preschool-aged children. The PRO WCV + Food Care condition uses the patient-clinic-community model to evaluate the additive effect of referring families to community-based programs that effectively improve food security and obesity prevention. We hypothesize the PRO WCV and PRO WCV + Food Care comparators will offer advantages over the standard WCV comparator by targeting parenting practices, nutrition (i.e., sugar-sweetened beverage intake), physical activity, screen time, and sleep behaviors leading to differences in child body mass index (BMI). Our overarching goal is to inform standard of clinical care for obesity prevention among preschool-aged children in rural, low-income families at high risk for obesity by comparing care delivery models to determine the value of connecting families, clinicians, and community-based services, offering excellent potential for dissemination.
Abstract Archived: Lay Abstract: What is the research about? Children who live in rural areas are twice as likely to be severely overweight than other children in the United States. Doctors can help prevent obesity through counseling at well-child visits. For example, they can refer families to community resources. In this study, the research team is comparing how well three types of well-child visits prevent obesity among preschool-aged children in rural areas. Who can this research help? Results may help doctors and parents of preschool-aged children when considering ways to prevent and treat childhood obesity. What is the research team doing? The research team is enrolling 2,040 children ages 2–5 and their families. Children are patients at a health system in rural Pennsylvania. The team is assigning children by chance to one of three groups. In the first group, each child attends their usual well-child visit, which includes counseling to prevent obesity. In the second group, each child attends their usual well-child visit. Before the visit, parents complete a survey about family nutrition and exercise. The survey informs the advice the doctor gives on preventing obesity. In the third group, each child attends their usual well-child visit, and a parent completes the survey. Parents also receive a referral to food care. In food care, parents receive six sessions with a trained wellness coach by video or phone. The wellness coaches help parents set goals for family meals, create bedtime routines, and exercise more as a family. Parents also receive an in-person or virtual grocery store tour from a nutritionist. The nutritionist helps parents compare products and choose healthy foods they can afford. At the start of the study and one year later, the research team is reviewing health records to collect children’s body mass index, or BMI, a measure of body size based on height and weight. The research team is comparing BMI for children in the three groups. Parents, primary care providers, wellness coaches, and nutritionists are helping to plan and conduct the study. Research methods at a glance Design Element Description Design Randomized controlled trial Population 2,040 children ages 2–5 living in rural areas Interventions/ Comparators Usual well-child visits Well-child visits plus parent-reported outcomes Well-child visits plus parent-reported outcomes plus food care Outcomes Primary: BMI Secondary: food security, patient’s perceptions of doctor-patient communication during the clinic visit, food resource management Timeframe 1-year follow-up for primary outcome.

MeSH Terms:
  • Body Mass Index
  • Child Obesity /*prevention & control
  • Child, Preschool
  • Cluster Analysis
  • Community Health Services /*organization & administration
  • Comparative Effectiveness Research
  • Health Behavior
  • Humans
  • Patient-Centered Care
  • Poverty
  • Primary Care /organization & administration
  • Randomized Controlled Trials as Topic
  • Rural Health Services /organization & administration
  • Rural Population
Country: United States
State: Pennsylvania
Zip Code: 17822
UI: 20202790
Project Status: Ongoing
Record History: ('Lay Title: Comparing Three Types of Well-Child Visits for Preventing Obesity among Preschool-Aged Children in Rural Areas',)