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

Geisinger Health

Status: Completed

Conditions: Mentoring; Pediatric Obesity; Food Supply; Preventive Medicine

Treatments: Behavioral: Patient Reported Outcome Well Child Visit + Food Care; Behavioral: Patient Reported Outcome Well Child Visit

Study type: Interventional

Funder types: Other

Identifiers

NCT04406441

2020-0207

Details and patient eligibility

About

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.

Enrollment: 2,040 patients

Sex: All

Ages: 20 to 59 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,040 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Patient Reported Outcome Well Child Visit

Patient Reported Outcome + Food Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Patient Reported Outcome Well Child Visit + Food Care