Clinical trial NCT04986046: Fruit and Vegetable Rx (FVRx) + Home Plate
Official title: Fruit and Vegetable Rx + Home Plate, a Multilevel Intervention to Improve Dietary Disparities Among Low-income Children and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Keywords: Diet quality
Cooking
Food security
Food access
Community food environment
Mental health
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: McClay Foundation
name: University of Pennsylvania
name: The Leo and Peggy Pierce Family Foundation
First posted: 2021-08-02
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Diet quality
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change in Food security - Food Security Survey
timeFrame: baseline and 8 weeks
measure: Change in Food security - Hunger Coping Scale
timeFrame: baseline and 8 weeks
measure: Change in Food security - 2-item Nutrition Security Screener (NSS)
timeFrame: baseline and 8 weeks
measure: Change in Caregiver diet quality
timeFrame: baseline and 8 weeks
measure: Change in Caregiver perceived food environment
timeFrame: baseline and 8 weeks
measure: Change in Caregiver mental health - Loneliness
timeFrame: baseline and 8 weeks
measure: Program feasibility - Voucher Redemption
timeFrame: 8 weeks
measure: Program feasibility - Home Plate Class Attendance
timeFrame: 8 weeks
measure: Program feasibility - Participant Satisfaction
timeFrame: 8 weeks
measure: Change in Urine Metabolites
timeFrame: Baseline and 8 weeks
measure: Change in Caregiver mental health - Depression
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
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