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

Study Overview
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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.

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

Conditions
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Pediatric Obesity, Preventive Medicine, Mentoring, Food Supply

Intervention / Treatment
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* Behavioral: Patient Reported Outcome Well Child Visit
* Behavioral: Patient Reported Outcome Well Child Visit + Food Care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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). | |
| Active Comparator: Patient Reported Outcome<br>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. | Behavioral: Patient Reported Outcome Well Child Visit<br>* 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.<br>|
| Active Comparator: Patient Reported Outcome + Food Care<br>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. | Behavioral: Patient Reported Outcome Well Child Visit + Food Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in difference in BMI z-score, based on WHO growth standards | BMI values will be obtained from Geisinger clinical care visits, documented in the EHR and standardized or parent-reported. Values obtained at well child visits during the study period, ideally 12 months, 1 day apart will be utilized but values within a 9- to 18-month span of baseline to 1-year follow up may be used (e.g., 3 months pre-baseline WCV to 15 months post-baseline, baseline WCV to 18-months post-baseline, etc.) may be used to assess the primary outcome. | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| United States Household Food Security Survey Module: Six-Item Short Form | The Six-item short form is an abbreviated form of the 10- and 18-item longer scales from the Economic Research Service, United States Department of Agriculture. A score of 0-1 indicates high or marginal food security; a score of 2-4 indicates low food security; a score of 5-6 indicates very low food security. Change in household food security status at 1-year is a planned analysis. | 1-year | 
| Modified Version of Perceived Involvement in Care Scale | The Modified Perceived Involvement in Care Scale (M-PICS) measures patients' perceptions of doctor-patient communication during the medical encounter. Subscale results are provided for 4 domains (each scored on a 1-5 item Likert scale). 1- Health care provider information evaluates the degree to which the provider is perceived as controlling information with a higher score indicating more controlling behavior. 2- Patient information evaluates the extent to which the patient sought or shared information with a higher score indicating greater patient activation in information gathering. 3- Patient decision making evaluates patient participation in decision making during care with a higher score indicating greater participation. 4- Health care provider facilitation reflects patients encouragement to ask questions with a higher score indicating greater facilitation. There is not a summary score. Change in perceived involvement in care by each subscale at 1-year are planned analyses. | 1-year | 
| Food Resource Management | Nine items from the Cooking Matters Food Resource Management survey that assess 2 subscales (each scored on 1-5 item Likert scale)- Food Resource Management Practices (indicating the frequency with which respondents engaged in behaviors to maximize food resources) and Food Resource Management Confidence (extent to which participants showed self-confidence in shopping, preparing foods, and managing food resources on a budget). Higher scores indicate more frequent practices and greater confidence, respectively. There is not a summary score. Change in food resource management by each subscale at 1-year are planned analyses. | 1-year |