Fruit and Vegetable Rx (FVRx) + Home Plate

NCT04986046 | Completed

• 1 other identifier: 20-018132
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Insecurity

Keywords

Diet quality; Cooking; Food security; Food access; Community food environment; Mental health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in Food security - Food Security Survey

  baseline and 8 weeks

• Change in Food security - Hunger Coping Scale

  baseline and 8 weeks

• Change in Food security - 2-item Nutrition Security Screener (NSS)

  baseline and 8 weeks

• Change in Caregiver diet quality

  baseline and 8 weeks

• Change in Caregiver perceived food environment

  baseline and 8 weeks

Study Arms (3)

Fruit and vegetable prescription

ACTIVE COMPARATOR

Fruit and vegetable incentive program

Other: Fruit and Vegetable prescription

Fruit and vegetable prescription + Home Plate Lite

EXPERIMENTAL

Fruit and vegetable incentive program + asynchronous, electronic resources delivered over six weeks (Home Plate Lite)

Other: Home Plate Lite; Other: Fruit and Vegetable prescription

Fruit and vegetable prescription + Home Plate

EXPERIMENTAL

Fruit and vegetable incentive program + 1.5-hour, virtual, small-group classes weekly for six weeks (Home Plate)

Other: Home Plate; Other: Fruit and Vegetable prescription

Interventions

Home Plate Lite OTHER

Home Plate Lite comprises electronic educational content (e.g. recipes, instructional videos) disbursed at least weekly over six weeks.

Fruit and vegetable prescription + Home Plate Lite

Home Plate OTHER

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.

Fruit and vegetable prescription + Home Plate

Fruit and Vegetable prescription OTHER

All families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia

Fruit and vegetable prescription; Fruit and vegetable prescription + Home Plate; Fruit and vegetable prescription + Home Plate Lite

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• McClay Foundation: collaborator
• University of Pennsylvania: collaborator
• The Leo and Peggy Pierce Family Foundation: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (30)

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MeSH Terms

Conditions

Psychological Well-Being

Interventions

Fruit

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: August 2, 2021
• Study Start: January 1, 2022
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)