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

NCT04406441 | Completed Results

• 1 other identifier: 2020-0207
• Study Type: interventional
• Target: 2,040
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Obesity; Preventive Medicine; Mentoring; Food Supply

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• United States Household Food Security Survey Module: Six-Item Short Form

  1-year

• Modified Version of Perceived Involvement in Care Scale

  1-year

• Food Resource Management

  1-year

Other Outcomes (3)

• Raw BMI

  1-year

• BMI Units Above the 50th Percentile (BMI50)

  1-year

• Percentage of Children Overweight and Obese

  1-year

Study Arms (3)

Standard of Care

NO INTERVENTION

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).

Patient Reported Outcome

ACTIVE COMPARATOR

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

Patient Reported Outcome + Food Care

ACTIVE COMPARATOR

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

Interventions

Patient Reported Outcome Well Child Visit BEHAVIORAL

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.

Patient Reported Outcome

Patient Reported Outcome Well Child Visit + Food Care BEHAVIORAL

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.

Patient Reported Outcome + Food Care

Eligibility Criteria

• Age: 20 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Another child in family is participating
• Parents with self-reported major depression will be excluded.

Sponsors & Collaborators

• Geisinger Clinic: lead
• Penn State University: collaborator
• Iowa State University: collaborator
• University of Nebraska: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Shawnee L Lutcher

Danville, Pennsylvania, 17822, United States

Location

Related Publications (4)

• 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.

  PMID: 22799481 BACKGROUND

• 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.

  PMID: 31275595 BACKGROUND

• 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.

  PMID: 36572870 BACKGROUND

• 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.

  PMID: 38496791 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations: Internal threats to validity may have influenced results including the Hawthorne effect and regression to the mean.

Results Point of Contact

• Title: Dr. Lisa Bailey-Davis
• Organization: Geisinger Health System

ldbaileydavis@geisinger.edu

570-214-9625

Study Officials

• Lisa Bailey-Davis, DEd, RD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 28, 2020
• Study Start: August 17, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)