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Clinical Trials/NCT04986046
NCT04986046
Completed
Not Applicable

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

Children's Hospital of Philadelphia1 site in 1 country120 target enrollmentJanuary 1, 2022
ConditionsFood Insecurity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Food Insecurity
Sponsor
Children's Hospital of Philadelphia
Enrollment
120
Locations
1
Primary Endpoint
Change in Diet quality
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
April 3, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • Program feasibility - Home Plate Class Attendance(8 weeks)
  • Program feasibility - Participant Satisfaction(8 weeks)
  • Change in Food security - Food Security Survey(baseline and 8 weeks)
  • Change in Caregiver diet quality(baseline and 8 weeks)
  • Change in Caregiver perceived food environment(baseline and 8 weeks)
  • Change in Urine Metabolites(Baseline and 8 weeks)
  • Change in Caregiver mental health - Depression(baseline and 8 weeks)
  • Change in Caregiver mental health - Loneliness(baseline and 8 weeks)
  • Program feasibility - Voucher Redemption(8 weeks)

Study Sites (1)

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