Food Insecurity Among ChildrenEDECHVANCT04218747
Evaluation of Demonstrations to End Childhood Hunger - VA
A study testing VA 365 Demonstration Benefits in people with Food Insecurity Among Children, run by USDA Food and Nutrition Service.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity Among Children
- What is being tested?
- VA 365 Demonstration Benefits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,750 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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."
Read the 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.
- Conditions
- Food Insecurity Among Children
- Being tested
- VA 365 Demonstration Benefits
- Keywords
- Food Security, National School Lunch Program (NSLP), School Breakfast Program (SBP), Child and Adult Care Food Program (CACFP), Food Backpacks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA 365 Demonstration BenefitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: VA 365 Demonstration Benefits |
| Control Group | No intervention | Schools in the control group operated under "business as usual." |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Previous 30 days: once before intervention start and once during intervention implementation
Secondary outcomes (3)
Very Low Food Insecurity among Children
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.
Measured: Previous 30 days: once before intervention start and once during intervention implementation
Food Insecurity among Adults
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.
Measured: Previous 30 days: once before intervention start and once during intervention implementation
Household Food Insecurity
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.
Measured: Previous 30 days: once before intervention start and once during intervention implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Insecurity Among ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Food and Nutrition Service
- Sponsor type
- US federal agency
- Collaborators
- Mathematica Policy Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael P Burke, PhD, Study director, USDA Food and Nutrition Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218747
- Sponsor's protocol ID
- AG-3198-C-14-0019 (Virginia)
- Acronym
- EDECHVA
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Demonstrations to End Childhood Hunger - VA
- ClinicalTrials.gov ID
- NCT04218747
- Acronym / sponsor ID
- EDECHVA / AG-3198-C-14-0019 (Virginia)
- Conditions
- Food Insecurity Among Children
- Keywords
- Food Security, National School Lunch Program (NSLP), School Breakfast Program (SBP), Child and Adult Care Food Program (CACFP), Food Backpacks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,750 participants (actual)
- Lead sponsor
- USDA Food and Nutrition ServiceUS federal agency
- Collaborators
- Mathematica Policy Research, Inc.
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA 365 Demonstration Benefits | Experimental | Behavioral: VA 365 Demonstration BenefitsChildren 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. |
| Control Group | No intervention | –Schools in the control group operated under "business as usual." |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VA 365 Demonstration BenefitsReducing 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. | Behavioural | VA 365 Demonstration Benefits |
Primary outcome
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.
3 secondary outcomes
Very Low Food Insecurity among Children
Time frame: 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
Household Food Insecurity
Time frame: Previous 30 days: once before intervention start and once during intervention implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Final ReportLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Burke, PhD study director
USDA Food and Nutrition Service
Questions about this trial
What is this clinical trial studying?
A study testing VA 365 Demonstration Benefits in people with Food Insecurity Among Children, run by USDA Food and Nutrition Service.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Insecurity among Children (time frame: Previous 30 days: once before intervention start and once during intervention implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.