- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04218747
Evaluation of Demonstrations to End Childhood Hunger - VA (EDECHVA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: To reduce hunger 365 days a year in households with schoolchildren by transforming schools into food hubs and providing nutrition education to parents.
Target Population: Elementary (n=30), middle (n=6), and high schools (n=2) in rural and urban VA. All schools had low academic performance and at least 50 percent of children eligible for free and reduced-price (FRP) meals.
Intervention: Schools were randomly assigned to either a treatment or control group. Children in treatment schools received: (1) three meals during the school day and food packages for weekends and school breaks; (2) $60 monthly Electronic Benefit Transfer (EBT) benefits during summer months if they were eligible for FRP meals; and (3) nutrition education for their parents. The control group operated under "business as usual." Note that the $60 monthly benefit was not included in the evaluation of the demonstration.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A selection of elementary, middle, and high schools in rural and urban Virginia, USA.
- Schools must have had low academic performance and at least 50% or children eligible for free and reduced price through the National School Lunch Program or participating in the Community Eligibility Provision.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: VA 365 Demonstration Benefits
Children in treatment schools received: (1) three meals during the school day and food packages for weekends and school breaks; (2) $60 monthly Electronic Benefit Transfer (EBT) benefits during summer months if they were eligible for FRP meals; and (3) nutrition education for their parents.
|
Reducing hunger 365 days a year in households with school children by transforming schools into food hubs ( free breakfast, lunch, supper, and food backpacks for the weekend) and providing nutrition education to parents.
|
|
NO_INTERVENTION: Control Group
Schools in the control group operated under "business as usual."
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food Insecurity among Children
Time Frame: Previous 30 days: once before intervention start and once during intervention implementation
|
Measured by the United States Department of Agriculture's Household Food Security Survey Module (HFSSM). Affirming 2 or more out of the 8 child-level items in the HFSSM. Higher scores generally indicates worsening food insecurity. |
Previous 30 days: once before intervention start and once during intervention implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Very Low Food Insecurity among Children
Time Frame: Previous 30 days: once before intervention start and once during intervention implementation
|
Measured by the United States Department of Agriculture's Household Food Security Survey Module (HFSSM). Affirming 5 or more out of the 8 child-level items in the HFSSM. Higher scores generally indicates worsening food insecurity. |
Previous 30 days: once before intervention start and once during intervention implementation
|
|
Food Insecurity among Adults
Time Frame: Previous 30 days: once before intervention start and once during intervention implementation
|
Measured by the United States Department of Agriculture's Household Food Security Survey Module (HFSSM). Affirming 3 or more out of the 10 adult-level items in the HFSSM. Higher scores generally indicates worsening food insecurity. |
Previous 30 days: once before intervention start and once during intervention implementation
|
|
Household Food Insecurity
Time Frame: Previous 30 days: once before intervention start and once during intervention implementation
|
Measured by the United States Department of Agriculture's Household Food Security Survey Module (HFSSM). Affirming 3 or more out of the 18 items in the HFSSM. Higher scores generally indicates worsening food insecurity. |
Previous 30 days: once before intervention start and once during intervention implementation
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AG-3198-C-14-0019 (Virginia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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