Clinical trial NCT04406441: Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children
Official title: Patient-Clinic-Community Integration to Prevent Obesity Among Rural Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Preventive Medicine
Mentoring
Food Supply
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Penn State University
name: Iowa State University
name: University of Nebraska
name: Patient-Centered Outcomes Research Institute
First posted: 2020-05-28
Enrollment: 2040
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Difference in BMI Z-score, Based on WHO Growth Standards
timeFrame: 1-year
Secondary outcomes:
measure: United States Household Food Security Survey Module: Six-Item Short Form
timeFrame: 1-year
measure: Modified Version of Perceived Involvement in Care Scale
timeFrame: 1-year
measure: Food Resource Management
timeFrame: 1-year
Other outcomes:
measure: Raw BMI
timeFrame: 1-year
measure: BMI Units Above the 50th Percentile (BMI50)
timeFrame: 1-year
measure: Percentage of Children Overweight and Obese
timeFrame: 1-year
Locations:
city: Danville
country: United States
facility: Shawnee L Lutcher
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Lisa Bailey-Davis, DEd, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.