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BMC public health
12 26, 2022;22 (1): 2429.

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

Lisa Bailey-Davis, Amy M Moore, Melissa N Poulsen, David A Dzewaltowski, Stacey Cummings, Laina R DeCriscio, Jennifer Franceschelli Hosterman, Daniel Huston, H Lester Kirchner, Shawnee Lutcher, Carolyn McCabe, Gregory J Welk, Jennifer S Savage
Author Information
  1. Lisa Bailey-Davis: Department of Population Health Sciences, Geisinger, 100 N Academy Ave, Danville, PA, 17822, USA. ldbaileydavis@geisinger.edu. ORCID
  2. Amy M Moore: Center for Childhood Obesity Research, The Pennsylvania State University, 129 Noll Laboratory, University Park, PA, 16802, USA.
  3. Melissa N Poulsen: Department of Population Health Sciences, Geisinger, 100 N Academy Ave, Danville, PA, 17822, USA.
  4. David A Dzewaltowski: College of Public Health, University of Nebraska Medical Center, 984365 Nebraska Medical Center, Omaha, NE, 68198, USA.
  5. Stacey Cummings: Department of Pediatrics, Geisinger, 100 N Academy Ave, Danville, PA, 17822, USA.
  6. Laina R DeCriscio: Health and Wellness, Steele Institute, Geisinger, 100 N Academy Ave, Danville, PA, 17822, USA.
  7. Jennifer Franceschelli Hosterman: Department of Pediatrics, Geisinger, 100 N Academy Ave, Danville, PA, 17822, USA.
  8. Daniel Huston: Health and Wellness, Steele Institute, Geisinger, 100 N Academy Ave, Danville, PA, 17822, USA.
  9. H Lester Kirchner: Department of Population Health Sciences, Geisinger, 100 N Academy Ave, Danville, PA, 17822, USA.
  10. Shawnee Lutcher: Center for Obesity & Metabolic Research, Geisinger, 100 N Academy Ave, Danville, PA, 17822, USA.
  11. Carolyn McCabe: Department of Population Health Sciences, Geisinger, 100 N Academy Ave, Danville, PA, 17822, USA.
  12. Gregory J Welk: Department of Kinesiology, Iowa State University, 103E Forker, 534 Wallace Rd, Ames, IA, 50011, USA.
  13. Jennifer S Savage: Center for Childhood Obesity Research, The Pennsylvania State University, 129 Noll Laboratory, University Park, PA, 16802, USA.
PMID: 36572870 DOI: 10.1186/s12889-022-14827-w

Abstract

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.

Keywords

Obesity Patient centered outcome Preschool-age Primary care Rural low-income

Associated Data

ClinicalTrials.gov | NCT04406441

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Grants

  1. CER-2019C1-16040/Patient-Centered Outcomes Research Institute

MeSH Term

Child
Child, Preschool
Humans
Pediatric Obesity
Parents
Body Mass Index
Overweight
Health Behavior
Randomized Controlled Trial Journal Article Research Support, Non-U.S. Gov't
Article has an altmetric score of 1

Word Cloud

Created with Highcharts 10.0.0WCVPROcareobesitywillplushealthchildrenprovidersparentspreventionstandardoutcomeFoodCareObesityPrimaryeffectivedeliverymodelsENCIRCLEstudycluster-randomizedcontrolledtrialwell-childvisitstelehealthprimaryincludesinformcounselingfoodresourcemanagementBMIzimplementationBACKGROUND:disproportionallyimpactsrurallower-incomeUnitedStateswell-positionedengageearlyyetlackevidenceregardingpragmaticrespondgaptestingcomparativeeffectivenessversustwoenhancements:addingpatient-reportedmeasurecoachinggrocerystoretourMETHODS:total2025preschool-aged20-60 monthsagerecruited24GeisingerclinicsrandomizedinterventionarmscollectionPRO-theFamilyNutritionPhysicalActivityFNPAriskassessment-fromParentscompletepatient-portalclinicdevicetabletkioskreceivereal-timefeedbackselectprioritytopicsdiscussproviderresultsintegratedchild'selectronicrecordpersonalizedpreventivereferralscommunityprofessionalsdeliverevidence-basedinterventionsviafollowingchangechildbodymassindexz-scorebasedWorldHealthOrganizationgrowthstandards12 monthspost-baselineAdditionaloutcomesincludepercentoverweightrawBMIBMI50extendedparentinvolvementbehaviorsprocessmeasuresDISCUSSION:Studyfindingssystems'choicespreventchildhoodamonghigh-riskpopulationAdditionallydisseminationinformedevaluationmediatingmoderatingfactorsTRIALREGISTRATION:ClinicalTrialsgovidentifierNCT04406441RegisteredMay282020Comparingenhancementsobesity:PatientcenteredPreschool-ageRurallow-income

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