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

NCT04406441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2040

Last updated 2025-03-05

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • Penn State University

    collaborator OTHER
  • Iowa State University

    collaborator OTHER
  • University of Nebraska

    collaborator OTHER
  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Geisinger Clinic

    lead OTHER

Principal Investigators

  • Lisa Bailey-Davis, DEd, RD · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406441 on ClinicalTrials.gov