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
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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