Fruit and Vegetable Rx (FVRx) + Home Plate

February 17, 2025 updated by: Children's Hospital of Philadelphia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to determine the effect of produce prescriptions (vouchers that can be redeemed for produce at participating locations, "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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  1. At least one child in the household is age 2 to 5 years.

  2. Household is food insecure and/or low-income with an age-eligible, overweight or obese child.

    • If a child meets the above criteria, any sibling age 2-5 is also eligible.

Exclusion Criteria

1. Caregiver or eligible children have a medical condition that significantly affects diet or eating habits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fruit and vegetable prescription
Fruit and vegetable incentive program
Other: Fruit and Vegetable prescription
All families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia
Experimental: Fruit and vegetable prescription + Home Plate Lite
Fruit and vegetable incentive program + asynchronous, electronic resources delivered over six weeks (Home Plate Lite)
Other: Fruit and Vegetable prescription
All families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia
Other: Home Plate Lite
Home Plate Lite comprises electronic educational content (e.g. recipes, instructional videos) disbursed at least weekly over six weeks.
Experimental: Fruit and vegetable prescription + Home Plate
Fruit and vegetable incentive program + 1.5-hour, virtual, small-group classes weekly for six weeks (Home Plate)
Other: Fruit and Vegetable prescription
All families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia
Other: Home Plate
Home Plate comprises six 1.5-hour weekly sessions where parents work together with a study staff member to discuss the learning objectives and prepare the components of a meal, including entrees, side dishes, and desserts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diet quality
Time Frame: baseline and 8 weeks
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
Time Frame: baseline and 8 weeks
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
Time Frame: baseline and 8 weeks
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
Time Frame: baseline and 8 weeks
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
Time Frame: baseline and 8 weeks
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
Time Frame: baseline and 8 weeks
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
Time Frame: 8 weeks
Program feasibility will be assessed through voucher redemption
8 weeks
Program feasibility - Home Plate Class Attendance
Time Frame: 8 weeks
Program feasibility will be assessed through virtual Home Plate class attendance
8 weeks
Program feasibility - Participant Satisfaction
Time Frame: 8 weeks
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
Time Frame: Baseline and 8 weeks
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
Time Frame: baseline and 8 weeks
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
Change in Food security - 2-item Nutrition Security Screener (NSS)
Time Frame: baseline and 8 weeks
Food security status will be assessed using the NSS. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania
McClay Foundation
The Leo and Peggy Pierce Family Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

April 3, 2024

Study Completion (Actual)

April 3, 2024

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-018132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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