NCT04218747

Brief Summary

The 2010 Child Nutrition Reauthorization provided funding to test innovative strategies to end childhood hunger and food insecurity. Demonstration projects were funded in Chickasaw Nation, Kentucky, Navajo Nation, Nevada, and Virginia. This study focuses on Virginia. A selection of 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."

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
Last Updated

January 6, 2020

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

December 12, 2019

Last Update Submit

January 3, 2020

Conditions

Keywords

Food SecurityNational School Lunch Program (NSLP)School Breakfast Program (SBP)Child and Adult Care Food Program (CACFP)Food Backpacks

Outcome Measures

Primary Outcomes (1)

  • Food Insecurity among Children

    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 Outcomes (3)

  • Very Low Food Insecurity among Children

    Previous 30 days: once before intervention start and once during intervention implementation

  • Food Insecurity among Adults

    Previous 30 days: once before intervention start and once during intervention implementation

  • Household Food Insecurity

    Previous 30 days: once before intervention start and once during intervention implementation

Study Arms (2)

VA 365 Demonstration Benefits

EXPERIMENTAL

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.

Behavioral: VA 365 Demonstration Benefits

Control Group

NO INTERVENTION

Schools in the control group operated under "business as usual."

Interventions

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.

VA 365 Demonstration Benefits

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Michael P Burke, PhD

    USDA Food and Nutrition Service

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

January 6, 2020

Study Start

September 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 6, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

Public-use data files are available by request by contacting Michael Burke (michael.burke@usda.gov) or the Office of Policy Support within the USDA Food and Nutrition Service.

More information