Fruit and Vegetable Rx (FVRx) + Home Plate

Study Overview
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Brief Summary
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This is a research study to test if fruit and vegetable prescription vouchers (FVRx) and a cooking skills program (Home Plate) can improve dietary quality, food security (access to a sufficient quantity of affordable, nutritious food), feelings about the home and community food environments, and caregiver mental health.

Detailed Description
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The purpose of this research study is to determine the effect of a fruit and vegetable voucher, a certificate redeemable in participating locations, program (FVRx) and a cooking skills program (Home Plate) on dietary quality, food security, perceptions of the food environment, and mental health. Investigators also aim to determine the feasibility and acceptability of the programs.

Official Title
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Fruit and Vegetable Rx + Home Plate, a Multilevel Intervention to Improve Dietary Disparities Among Low-income Children and Families

Conditions
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Food Insecurity

Intervention / Treatment
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* Other: Home Plate Lite
* Other: Virtual Home Plate
* Other: Fruit and Vegetable prescription


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one child in the household is age 2 to 5 year Household is food insecure and/or low-income with an age-eligible, overweight or obese child Exclusion Criteria: Caregiver or eligible children have a medical condition that significantly affects diet or eating habits

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fruit and vegetable prescription<br>Fruit and vegetable incentive program | Other: Fruit and Vegetable prescription<br>* All families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia<br>|
| Experimental: Fruit and vegetable prescription + Home Plate Lite<br>Fruit and vegetable incentive program + asynchronous, electronic resources delivered over six weeks | Other: Home Plate Lite<br>* Home Plate Lite comprises electronic educational content (e.g. recipes, instructional videos) disbursed at least weekly.<br>Other: Fruit and Vegetable prescription<br>* All families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia<br>|
| Experimental: Fruit and vegetable prescription + Virtual Home Plate<br>Fruit and vegetable incentive program + 45-minute, virtual, small-group classes twice weekly for six weeks | Other: Virtual Home Plate<br>* Virtual Home Plate comprises two, 45-minute weekly sessions where parents work together with a study staff member to discuss the themes and prepare the components of a meal, including entrees, side dishes, and desserts.<br>Other: Fruit and Vegetable prescription<br>* All families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diet quality | Diet quality of the child will be measured by use of an automated self-administered 24-hour dietary recall system (ASA24), completed by the child's caregiver. The ASA24 is a web-based tool that enables automatically coded, self-administered 24-hour diet recalls, providing high-quality dietary data. The ASA24 system is adapted from the United States Department of Agriculture (USDA) Automated Multiple-Pass Method, which has been validated. Validation and evaluation studies of ASA24 have found close agreement with standardized interview-administered 24 hour recall. | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Food security - Food Security Survey | Food security status will be assessed using the USDA Food Security Survey. The 18-item USDA Food Security Survey the time period (e.g. last 30 days) and specify lack of resources as the reason for the behavior or experience (e.g. couldn't afford more food, or there was not enough money for food) to determine the level food security (very low, low, marginal, and full). Participants are asked to check boxes next to statements that best describe their behavior. These surveys will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the intervention. | baseline and 8 weeks | 
| Change in Food security - Hunger Coping Scale | Food security status will be assessed using the Hunger Coping Scale. The five items from the Hunger Coping Scale question the time period (e.g. last 30 days) and specify lack of resources as the reason for the behavior or experience (e.g. couldn't afford more food, or there was not enough money for food) to determine the level food security (very low, low, marginal, and full). Participants are asked to check boxes next to statements that best describe their behavior. These surveys will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the intervention. | baseline and 8 weeks | 
| Change in Caregiver diet quality | Caregiver diet quality will be measured by the caregivers completion of the automated self-administered 24-hour dietary recall system (ASA24) for themselves at baseline and 8 weeks following the initiation of the nutrition education intervention. The ASA24, is a web-based tool that enables automatically coded, self-administered 24-hour diet recalls, providing high-quality dietary data. The ASA24 system is adapted from the USDA Automated Multiple-Pass Method, which has been validated. | baseline and 8 weeks | 
| Change in Caregiver perceived food environment | Perceptions of food environment will be assessed using the Perceived Nutrition Environment Measures survey (NEMS-P). The survey is completed by the person who does the majority of the food shopping in a household to learn about his/her perceptions of the nutrition environments (where food is consumed or purchased, and in the home). Participants are asked to check boxes next to statements that best describe their behavior (e.g. strongly disagree to strongly agree or never or rarely to almost always. Components within the survey ar examined individually. The survey can discriminate perceptions of nutrition environments between residents of higher- and lower-socioeconomic status (SES) neighborhoods. The NEMS-P will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the nutrition education intervention. | baseline and 8 weeks | 
| Change in Caregiver mental health - Loneliness | Caregiver mental health will be measured using the Revised UCLA (R-UCLA) Loneliness Scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item on a scale from hardly ever to often. Minimum score is 3 maximum score is 9; higher scores indicate worse outcome. | baseline and 8 weeks | 
| Program feasibility - Voucher Redemption | Program feasibility will be assessed through voucher redemption | 8 weeks | 
| Program feasibility - Home Plate Class Attendance | Program feasibility will be assessed through virtual Home Plate class attendance | 8 weeks | 
| Program feasibility - Participant Satisfaction | Program feasibility will be assessed through participant feedback measured by completion of the participant satisfaction surveys and phone interviews post intervention. | 8 weeks | 
| Change in Urine Metabolites | Urine samples will be collected from subjects at baseline and 8 weeks and measured by metabolomic analysis to quantify association with dietary biomarkers. | Baseline and 8 weeks | 
| Change in Caregiver mental health - Depression | The Center for Epidemiologic Studies Depressive Scale (CES-D) is a 20-item questionnaire that includes a brief self-report for which the scale is designed to measure self-reported symptoms associated with depression experienced in the past week. Participants rate each item on a scale from 0= Rarely or none of the time (less than 1-day), 1= Some or a little of the time (1-2 days), 2= Occasionally or a moderate amount of the time (3-4 days, or 3=Most or all of the time (5-7 days).The scale will be administered via REDCap with telephonic support by study staff at baseline and 8 weeks following the initiation of the interventions. High scores indicating greater depressive symptoms. | baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet quality, Cooking, Food security, Food access, Community food environment, Mental health