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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-17

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pediatric Obesity Preventive Medicine Mentoring Food Supply

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard of Care

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Patient Reported Outcome

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.

Group Type ACTIVE_COMPARATOR

Patient Reported Outcome Well Child Visit

Intervention Type BEHAVIORAL

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.

Patient Reported Outcome + Food Care

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.

Group Type ACTIVE_COMPARATOR

Patient Reported Outcome Well Child Visit + Food Care

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

20 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes