Food Insecurity Among ChildrenEDECHNVNCT04253743
Evaluation of Demonstrations to End Childhood Hunger - NV
A study testing Nevada Healthy, Hunger-Free Kids 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 Nevada. Read more about this study
- Who is it for?
- Ages Up to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity Among Children
- What is being tested?
- Nevada Healthy, Hunger-Free Kids Demonstration Benefits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,246 participants
- Where
- No sites listed yet
- Study dates
- Jun 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 Up to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Supplemental Nutrition Assistance Program (SNAP) households with children under age 5 and incomes below 75 percent of the Federal Poverty Level living in Clark County, Las Vegas, Nevada.
Who cannot join
None listed.
About this study
Official title: Evaluation of Demonstrations to End Childhood Hunger - Nevada
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 Nevada.
SNAP households were randomly assigned to receive either: (1) $40 extra in SNAP benefits per eligible child (<5 years) per month; (2) $40 extra in SNAP benefits per eligible child per month plus case management and nutrition education; or (3) only regular monthly SNAP benefit. The first two groups were the treatment arms and the third was the control group.
Read the detailed description
Objectives: To (1) reduce food insecurity among children; (2) increase enrollment in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and other nutrition assistance programs; and (3) improve nutrition and healthy shopping habits through nutrition education.
Target Population: Supplemental Nutrition Assistance Program (SNAP) households with children under age 5 and incomes below 75 percent of the Federal Poverty Level living in Clark County, Las Vegas, Nevada.
Intervention: SNAP households were randomly assigned to receive either: (1) $40 extra in SNAP benefits per eligible child (<5 years) per month; (2) $40 extra in SNAP benefits per eligible child per month plus case management and nutrition education; or (3) only regular monthly SNAP benefit. The first two groups were the treatment arms and the third was the control group.
The two treatment groups were ultimately combined because of the low uptake of case management and nutrition education.
- Conditions
- Food Insecurity Among Children
- Being tested
- Nevada Healthy, Hunger-Free Kids Demonstration Benefits
- Keywords
- Food security, Hunger, Young children, Supplemental Nutrition Assistance Program (SNAP), Food expenditures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevada Healthy, Hunger-Free Kids Demonstration BenefitsOther
SNAP households with children under age 5 incomes below 75% of the federal poverty level living in Clark County, Nevada received $40 in extra SNAP benefits per eligible child, and access to case management and nutrition education.
| Study group | Role | What they receive |
|---|---|---|
| Nevada Healthy, Hunger-Free Kids Demonstration Benefits | Experimental | SNAP households were randomly assigned to receive either: (1) $40 extra in SNAP benefits per eligible child (<5 years) per month (n=1,919); (2) $40 extra in SNAP benefits per eligible child per month plus case management and nutrition education (n=1,919); or (3) only regular monthly SNAP benefit (n=7,467). The first two groups were the treatment arms and the third was the control group. Receives: Other: Nevada Healthy, Hunger-Free Kids Demonstration Benefits |
| Control Group | No intervention | The control group received regularly allotted SNAP benefits. |
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: 30 days
Secondary outcomes (4)
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: 30 days
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: 30 days
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: 30 days
Food Expenditures
Total amount of Supplemental Nutrition Assistance Program (SNAP) and out-of-pocket food purchases in dollars
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startJun 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 7,246 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
- NCT04253743
- Sponsor's protocol ID
- AG-3198-C-14-0019 (Nevada)
- Acronym
- EDECHNV
- Status last verified
- Jan 2020
- First submitted
- 12 Dec 2019
- Last updated
- 5 Feb 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.
Publications
Gleason PM, Kleinman R, Chojnacki GJ, Briefel RR, Forrestal SG. Measuring the Effects of a Demonstration to Reduce Childhood Food Insecurity: A Randomized Controlled Trial of the Nevada Healthy, Hunger Free Kids Project. J Acad Nutr Diet. 2021 Jan;121(1S):S22-S33. doi: 10.1016/j.jand.2020.03.002.
PubMed 33342522
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Demonstrations to End Childhood Hunger - Nevada
- ClinicalTrials.gov ID
- NCT04253743
- Acronym / sponsor ID
- EDECHNV / AG-3198-C-14-0019 (Nevada)
- Conditions
- Food Insecurity Among Children
- Keywords
- Food security, Hunger, Young children, Supplemental Nutrition Assistance Program (SNAP), Food expenditures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,246 participants (actual)
- Lead sponsor
- USDA Food and Nutrition ServiceUS federal agency
- Collaborators
- Mathematica Policy Research, Inc.
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 5 Feb 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 Nevada.
SNAP households were randomly assigned to receive either: (1) $40 extra in SNAP benefits per eligible child (<5 years) per month; (2) $40 extra in SNAP benefits per eligible child per month plus case management and nutrition education; or (3) only regular monthly SNAP benefit. The first two groups were the treatment arms and the third was the control group.
Detailed description
Objectives: To (1) reduce food insecurity among children; (2) increase enrollment in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and other nutrition assistance programs; and (3) improve nutrition and healthy shopping habits through nutrition education.
Target Population: Supplemental Nutrition Assistance Program (SNAP) households with children under age 5 and incomes below 75 percent of the Federal Poverty Level living in Clark County, Las Vegas, Nevada.
Intervention: SNAP households were randomly assigned to receive either: (1) $40 extra in SNAP benefits per eligible child (<5 years) per month; (2) $40 extra in SNAP benefits per eligible child per month plus case management and nutrition education; or (3) only regular monthly SNAP benefit. The first two groups were the treatment arms and the third was the control group.
The two treatment groups were ultimately combined because of the low uptake of case management and nutrition education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nevada Healthy, Hunger-Free Kids Demonstration Benefits | Experimental | Other: Nevada Healthy, Hunger-Free Kids Demonstration BenefitsSNAP households were randomly assigned to receive either: (1) $40 extra in SNAP benefits per eligible child (<5 years) per month (n=1,919); (2) $40 extra in SNAP benefits per eligible child per month plus case management and nutrition education (n=1,919); or (3) only regular monthly SNAP benefit (n=7,467). The first two groups were the treatment arms and the third was the control group. |
| Control Group | No intervention | –The control group received regularly allotted SNAP benefits. |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Supplemental Nutrition Assistance Program (SNAP) households with children under age 5 and incomes below 75 percent of the Federal Poverty Level living in Clark County, Las Vegas, Nevada.
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 |
|---|---|---|
| Nevada Healthy, Hunger-Free Kids Demonstration BenefitsSNAP households with children under age 5 incomes below 75% of the federal poverty level living in Clark County, Nevada received $40 in extra SNAP benefits per eligible child, and access to case management and nutrition education. | Other | Nevada Healthy, Hunger-Free Kids Demonstration Benefits |
Primary outcome
Food Insecurity among Children
Time frame: 30 days
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.
4 secondary outcomes
Very Low Food Insecurity among Children
Time frame: 30 days
Food Insecurity among Adults
Time frame: 30 days
Household Food Insecurity
Time frame: 30 days
Food Expenditures
Time frame: 30 days
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 5 Feb 2020.
- Derived from this study: PubMed 33342522Gleason PM, Kleinman R, Chojnacki GJ, Briefel RR, Forrestal SG. Measuring the Effects of a Demonstration to Reduce Childhood Food Insecurity: A Randomized Controlled Trial of the Nevada Healthy, Hunger Free Kids Project. J Acad Nutr Diet. 2021 Jan;121(1S):S22-S33. doi: 10.1016/j.jand.2020.03.002.
- 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 Nevada Healthy, Hunger-Free Kids 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 1 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 5 Feb 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: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04253743, which also lists 1 linked publication.
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 5 Feb 2020.