Assessment of a Fruit and Vegetable Prescription Program for Children

Study Overview
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Brief Summary
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The objective of this study is to address gaps in knowledge related to the influence of pediatric fruit and vegetable prescription programs on food security, child dietary patterns, and weight status. To do this, we will compare demographically similar pediatric patient groups from three large clinics in a low-income urban city based on their exposure to a fruit and vegetable prescription program (FVPP) that provides one $15 prescription for fresh fruits and vegetable to every child at every office visit. Three clusters will be identified based on child exposure to the pediatric FVPP at baseline: high exposure (>24 months), moderate exposure (12-24 months), and no previous exposure. We will then introduce the FVPP to never exposed patients and collect, record, and compare changes in dietary intake, food security, and weight status over time. We will test the hypothesis that exposure to the FVPP is associated with higher intake of fruits and vegetables, better food security, and lower rates of obesity among children. The first aim will compare baseline dietary intake, food security, and weight status between high exposure, moderate exposure, no exposure groups. The second aim will measure changes in diet, food security, and weight status at 6-, 12-, 18-, and 24-months among children newly exposed to the FVPP. The third aim will compare follow-up measures of dietary intake, food security, and weight status in the initial no exposure group to baseline measures in the high exposure group.

Detailed Description
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This study will evaluate a Fruit and Vegetable Prescription Program (FVPP). The program provides one $15 prescription for fresh produce to every child at every office visit. Prescriptions are redeemable at a local farmers' market and mobile market. To determine whether exposure to the FVPP is associated with improvements in dietary intake, food security, and health status, we will compare demographically similar pediatric patient groups with varying levels of exposure to the FVPP at baseline: high exposure (>24 months), moderate exposure (12-24 months), and no previous exposure. We will then introduce the FVPP to never exposed patients and collect, record, and compare changes in dietary intake, food security, and weight status over time. The central hypothesis is that exposure to the FVPP is associated with higher intake of fruits and vegetables, better food security, and lower rates of childhood obesity over time. We propose the following three specific aims to test our hypothesis: Aim 1 - Compare baseline dietary intake, food security, and weight status between pediatric patients with varying levels of exposure to the FVPP. Aim 2 - Measure changes in diet, food security, and weight status when never exposed children are introduced to the FVPP. Aim 3 - Compare mean follow-up measures of dietary intake, food security, and weight status in the initial no exposure group to baseline measures in the high exposure group.

Official Title
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Innovative Nutrition Practices in Pediatric Health Care: Assessment of a Fruit and Vegetable Prescription Program for Children in Need

Conditions
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Exposure to Fruit and Vegetable Prescription Program

Intervention / Treatment
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* Other: Fruit and Vegetable Prescription


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child between age 8 and 16 years and their caregiver; Child active patient at clinic; Child received at least one fruit and vegetable prescription; Child and caregiver English-speaking Exclusion Criteria: Caregiver or child not English speaking; Legal guardian not present at enrollment; Child assent refused; Sibling previously enrolled (one caregiver and one child per household); Movement between participating clinics

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

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
Intervention Model: Single Group Assignment
Interventional Model Description: A fruit and vegetable prescription is written by pediatricians to exchange for $15 of fresh produce. Prescriptions are redeemable at a local farmers' market and mobile market.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fruit and Vegetable Prescription<br>Each program participant will receive a fruit and vegetable prescription that is written by pediatricians to exchange for $15 of fresh produce. Prescriptions will be distributed during pediatric office visits and are redeemable at a local farmers' market and mobile market. | Other: Fruit and Vegetable Prescription<br>* $15 voucher for fruit and vegetables<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline child-reported mean daily intake of fruits and vegetables at 12 months | Dietary data from children will be collected via two non-consecutive dietary recalls and one validated food frequency questionnaire. Two non-consecutive 24-hour dietary recalls will be collected using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. We will also administer Block Kids Food Screener, a food frequency questionnaire, to allow for the assessment of usual and long-term eating behaviors. The Block Kids Food Screener will provide nutrient estimates and number of servings by food groups. We will use this data to determine change in child-reported mean daily intake of total fruits and vegetables, total vegetables, total fruits, and whole fruits. | 12 months | 
| Change from baseline household food security at 12 months | Caregivers will complete the US Household Food Security Survey Module: 6 Item Short Form (National Center for Health Statistics) to measure household food insecurity and hunger. | 12 months | 
| Change from baseline child-reported food security at 12 months | The Self-Administered Food Security Survey Module for Youth will be used to estimate perceived food security among youth 12 years of age and older. | 12 months | 
| Change from baseline child-reported food security at 24 months | The Self-Administered Food Security Survey Module for Youth will be used to estimate perceived food security among youth 12 years of age and older. | 24 months | 
| Change from baseline child-reported mean daily intake of fruits and vegetables at 24 months | Dietary data from children will be collected via two non-consecutive dietary recalls and one validated food frequency questionnaire. Two non-consecutive 24-hour dietary recalls will be collected using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool. We will also administer Block Kids Food Screener, a food frequency questionnaire, to allow for the assessment of usual and long-term eating behaviors. The Block Kids Food Screener will provide nutrient estimates and number of servings by food groups. We will use this data to determine change in child-reported mean daily intake of total fruits and vegetables, total vegetables, total fruits, and whole fruits. | 24 months | 
| Change from baseline household food security at 24 months | Caregivers will complete the US Household Food Security Survey Module: 6 Item Short Form (National Center for Health Statistics) to measure household food insecurity and hunger. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline child BMI at 12 months | Youth weight and height will be measured without shoes or heavy outer garments. On each occasion two measures will be made, and the averages will be recorded. Height will be measured to the closest 0.1 cm using a portable stadiometer. Weight will be measured to the closest 0.2 kg on a digital platform scale accurate to 200 kg. Weight and height will be combined to report BMI in kg/m^2. | 12 months | 
| Change from baseline child BMI at 24 months | Youth weight and height will be measured without shoes or heavy outer garments. On each occasion two measures will be made, and the averages will be recorded. Height will be measured to the closest 0.1 cm using a portable stadiometer. Weight will be measured to the closest 0.2 kg on a digital platform scale accurate to 200 kg. Weight and height will be combined to report BMI in kg/m^2. | 24 months | 
| Change from caregiver-reported baseline mean daily intake of fruits and vegetables at 12 months | Dietary information will be collected from caregivers using the National Cancer Institute Fruit & Vegetable Intake All Day Screener which asks frequency and portion size questions about nine food items. | 12 months | 
| Change from caregiver-reported baseline mean daily intake of fruits and vegetables at 24 months | Dietary information will be collected from caregivers using the National Cancer Institute Fruit & Vegetable Intake All Day Screener which asks frequency and portion size questions about nine food items. | 24 months |