Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children (ENCIRCLE)

The goal of this research study is to compare two enhancements to well-child visits at Geisinger designed to promote family-centered counseling for the prevention of obesity in a high-risk population of rural, lower income, preschool-aged children. Compared to the standard well-child visit, enhancements will offer advantages to obesity prevention, parent involvement in counseling, lifestyle behaviors, and food resource management.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity; Preventive Medicine; Mentoring; Food Supply
• Intervention / Treatment: Behavioral: Patient Reported Outcome Well Child Visit; Behavioral: Patient Reported Outcome Well Child Visit + Food Care

• Study Type: Interventional
• Enrollment (Actual): 2040
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Shawnee L Lutcher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age (20-months to 59-months, 29-days old)
• BMI-for-age and -sex >50th percentile based on WHO growth standards
• Parent commitment to participate in 18-month study
• Plans to attend scheduled WCV and recommended follow-up WCV in 12 months
• No plans to move or change health systems in 2 years
• Parent age > 18 years
• Parent is English-speaking
• Household is considered lower-income (i.e., eligible for or receiving Special Supplemental Nutrition Program for Women, Infants and Children [WIC], Supplemental Nutrition Assistance Program [SNAP], Temporary Assistance for Needy Families [TANF], Medicaid, or Children's Health Insurance Program [CHIP]) or screens positive for food insecurity.

Exclusion Criteria:

• Another child in family is participating
• Pre-existing medical exclusions (cancer, type 1 diabetes, major developmental delays such as autism)
• Parents with self-reported major depression will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Participants will attend regularly scheduled well child visits (WCV) that follow standard clinical guidelines. Well child visits will include review of history, age-appropriate measurements (height/length, weight, body mass index (BMI), blood pressure), sensory and developmental screenings, physical exam, immunizations, oral health review, and anticipatory guidance (preventive counseling).
Active Comparator: Patient Reported Outcome; Arm 2 builds on the standard of care WCV by adding a patient reported outcome measure, the Family Nutrition and Physical Activity risk assessment, to inform family-centered preventative counseling during clinical care.	Behavioral: Patient Reported Outcome Well Child Visit; Parents will complete the Family Nutrition and Physical Activity risk assessment (Patient Reported Outcome) prior to scheduled well child visit. Parent reported data is integrated into the child's electronic health record to inform the child's primary care provider and the provision of preventive counseling. The primary care provider documents preventive care provided.
Active Comparator: Patient Reported Outcome + Food Care; Participants will receive all Arm 2 components, in addition to be referred to both the Geisinger Wellness Program for a Parent Training Program and a grocery store nutritionist for a tour aligned with the Cooking Matters program.	Behavioral: Patient Reported Outcome Well Child Visit + Food Care; Adapted Parent Training Program will be delivered via telehealth (video or telephone) to parents by trained Wellness Coaches as 6 individual sessions, distributed throughout a 26-week intervention period. Cooking Matters grocery store tours will be delivered (in-person or virtual) to parents by trained grocery store nutritionists during the 26-week intervention period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in BMI Z-score, Based on WHO Growth Standards	BMI values will be obtained from Geisinger clinical care visits, documented in the EHR and standardized or parent-reported. Values obtained at well child visits during the study period, ideally 12 months, 1 day apart will be utilized but values within a 9- to 18-month span of baseline to 1-year follow up may be used (e.g., 3 months pre-baseline WCV to 15 months post-baseline, baseline WCV to 18-months post-baseline, etc.) to assess the primary outcome. A z-score of 0 represents the population mean. Higher z-scores represent worse outcomes. BMI z-score over >=1 indicates possible risk for overweight.	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
United States Household Food Security Survey Module: Six-Item Short Form	This questionnaire uses 6 items to provide a scale of food security of high food security to very low food security. Scoring: Responses of "often" or "sometimes" on questions Q1 and Q2, and "yes" on Q3, Q5, and Q6 are coded as affirmative (yes). Responses of "almost every month" and "some months but not every month" on Q4 are coded as affirmative (yes). The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Food security status is assigned as follows: Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale); Raw score 2-4-Low food security. Raw score 5-6-Very low food security. Percentage of participants with low or very low food security scores were reported.	1-year
Modified Version of Perceived Involvement in Care Scale	The Modified Perceived Involvement in Care Scale (M-PICS) measures patients' perceptions of doctor-patient communication during the medical encounter. PICs includes 4 domains including 1-Health care provider information 2- Patient information 3- Patient decision making 4- Health care provider facilitation. The total score combines these 4 domains with a range from 20 poor-100 high reported at 12-month follow-up.	1-year
Food Resource Management	Nine items from the Cooking Matters Food Resource Management survey that assess 2 subscales (each scored on 1-5 item Likert scale)- Food Resource Management Practices (indicating the frequency with which respondents engaged in behaviors to maximize food resources) and Food Resource Management Confidence (extent to which participants showed self-confidence in shopping, preparing foods, and managing food resources on a budget). Higher scores indicate more frequent practices and greater confidence, respectively. There is not a summary score. The scoring for each subscale uses the average of items within that subscale.	1-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raw BMI	Differences in raw BMI will be evaluated amongst study arms.	1-year
BMI Units Above the 50th Percentile (BMI50)	Differences in BMI50 will be evaluated amongst study arms. We reported using mean number of BMI units from the population mean which is defined as the distance from the BMI for age and sex at the 50th %tile.	1-year
Percentage of Children Overweight and Obese	Evaluate the percentage of children overweight and obese at 1-year follow-up per CDC guidance and definitions.	1-year

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: Patient-Centered Outcomes Research Institute; Penn State University; University of Nebraska; Iowa State University
• Investigators: Principal Investigator: Lisa Bailey-Davis, DEd, RD, Geisinger Clinic

Publications and helpful links

General Publications

• Slusser W, Frankel F, Robison K, Fischer H, Cumberland WG, Neumann C. Pediatric overweight prevention through a parent training program for 2-4 year old Latino children. Child Obes. 2012 Feb;8(1):52-9. doi: 10.1089/chi.2011.0060.
• Bailey-Davis L, Kling SMR, Wood GC, Cochran WJ, Mowery JW, Savage JS, Stametz RA, Welk GJ. Feasibility of enhancing well-child visits with family nutrition and physical activity risk assessment on body mass index. Obes Sci Pract. 2019 Apr 24;5(3):220-230. doi: 10.1002/osp4.339. eCollection 2019 Jun.
• Bailey-Davis L, Moore AM, Poulsen MN, Dzewaltowski DA, Cummings S, DeCriscio LR, Hosterman JF, Huston D, Kirchner HL, Lutcher S, McCabe C, Welk GJ, Savage JS. Comparing enhancements to well-child visits in the prevention of obesity: ENCIRCLE cluster-randomized controlled trial. BMC Public Health. 2022 Dec 26;22(1):2429. doi: 10.1186/s12889-022-14827-w.
• Potts BA, Wood GC, Bailey-Davis L. Agreement between parent-report and EMR height, weight, and BMI among rural children. Front Nutr. 2024 Mar 1;11:1279931. doi: 10.3389/fnut.2024.1279931. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 2020-0207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No