Fruit and Vegetable Rx (FVRx) + Home Plate

Food Insecurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986046
• Other study ID #: 20-018132
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Children's Hospital of Philadelphia
• Contact: Senbagam Virudachalam, MD
• Phone: 215-590-6753
• Email: virudachalams[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Insecurity

Intervention

Other:
• Home Plate Lite
Home Plate Lite comprises electronic educational content (e.g. recipes, instructional videos) disbursed at least weekly.
• Virtual Home Plate
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.
• 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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	McClay Foundation, The Leo and Peggy Pierce Family Foundation, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (30)

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Olsho LE, Klerman JA, Wilde PE, Bartlett S. Financial incentives increase fruit and vegetable intake among Supplemental Nutrition Assistance Program participants: a randomized controlled trial of the USDA Healthy Incentives Pilot. Am J Clin Nutr. 2016 Aug;104(2):423-35. doi: 10.3945/ajcn.115.129320. Epub 2016 Jun 22. — View Citation

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Pinard C, Smith TM, Calloway EE, Fricke HE, Bertmann FM, Yaroch AL. Auxiliary measures to assess factors related to food insecurity: Preliminary testing and baseline characteristics of newly designed hunger-coping scales. Prev Med Rep. 2016 Jun 29;4:289-95. doi: 10.1016/j.pmedr.2016.06.021. eCollection 2016 Dec. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in Food security - 2-item Nutrition Security Screener (NSS)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Program feasibility - Voucher Redemption	Program feasibility will be assessed through voucher redemption	8 weeks
Secondary	Program feasibility - Home Plate Class Attendance	Program feasibility will be assessed through virtual Home Plate class attendance	8 weeks
Secondary	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
Secondary	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
Secondary	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