N/A
N=4,080
Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children
Pediatric Obesity · Preventive Medicine · Mentoring · Food Supply
Bottom Line
View on ClinicalTrials.gov: NCT04406441 ↗Enrolled (actual)
4,080
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Difference in BMI Z-score, Based on WHO Growth Standards — 1.005; 0.881; 0.979 BMI z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Reported Outcome Well Child Visit (Behavioral); Patient Reported Outcome Well Child Visit + Food Care (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Geisinger Clinic
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in BMI Z-score, Based on WHO Growth Standards |
1.005; 0.881; 0.979 | — |
| SECONDARY United States Household Food Security Survey Module: Six-Item Short Form |
16.9; 18.4; 21.4 | — |
| SECONDARY Modified Version of Perceived Involvement in Care Scale |
71.81; 71.99; 72.92 | — |
| SECONDARY Food Resource Management |
3.76; 3.74; 3.78; 3.96; 3.93; 4.03 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04406441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.