Food Insecurity Among ChildrenEDECHCNFOODSECNCT04316819
Evaluation of Demonstrations to End Childhood Hunger - CN Food Sec
A study testing Packed Promise 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 Chickasaw Nation. 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?
- Packed Promise Demonstration Benefits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,750 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 2018
- 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
- 40 school districts (115 schools) in 12 counties within the Chickasaw Nation territory in Oklahoma.
- Within these districts, households with school-age children (both Native American and non-Native American) who were eligible for free National School Lunch Program meals or attended a school that participated in the community eligibility provision were eligible to participate in the project.
Who cannot join
None listed.
About this study
Official title: Evaluation of Demonstrations to End Childhood Hunger - CN Food Security
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 Chickasaw Nation.
School districts were matched, and then one was randomly assigned to either a treatment (n=20) or control group (n=20). Treatment households received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. Control households did not receive the treatment benefits but still could participate in other available nutrition assistance programs.
Read the detailed description
Objective: To reduce childhood food insecurity and hunger, increase families' consumption of nutritious foods, increase the diversity of foods in the home, and ultimately improve diet quality and well-being among children.
Target Population: 40 school districts (115 schools) in 12 counties within the Chickasaw Nation territory in Oklahoma. Within these districts, households with school-age children (both Native American and non-Native American) who were eligible for free school meals or attended a school that participated in the community eligibility provision were eligible to participate in the project.
Intervention School districts were matched, and then one was randomly assigned to either a treatment (n=20) or control group (n=20). Treatment households received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. Control households did not receive the treatment benefits but still could participate in other available nutrition assistance programs.
- Conditions
- Food Insecurity Among Children
- Being tested
- Packed Promise Demonstration Benefits
- Keywords
- Food security, Hunger, School children, Indian Tribal Organization, Home-delivered food box
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packed Promise Demonstration BenefitsOther
Monthly: Home-delivered food box, nutrition education handout, and $15 monthly voucher for fruits and vegetables
| Study group | Role | What they receive |
|---|---|---|
| Packed Promise Demonstration Benefits | Experimental | Treatment households (n=2,143) received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. Receives: Other: Packed Promise Demonstration Benefits |
| Control Group | No intervention | Control households (n=2,607) did not receive the treatment benefits but still could participate in other available nutrition assistance programs. |
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 posted20 Mar 2020
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
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
- 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
- NCT04316819
- Sponsor's protocol ID
- AG-3198-C-14-0019 (CN FoodSec)
- Acronym
- EDECHCNFOODSEC
- Status last verified
- Mar 2020
- First submitted
- 12 Dec 2019
- Last updated
- 20 Mar 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
Briefel RR, Chojnacki GJ, Gabor V, Forrestal SG, Kleinman R, Cabili C, Gleason PM. A Cluster Randomized Controlled Trial of a Home-Delivered Food Box on Food Security in Chickasaw Nation. J Acad Nutr Diet. 2021 Jan;121(1S):S46-S58. doi: 10.1016/j.jand.2020.07.021.
PubMed 33342524
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Demonstrations to End Childhood Hunger - CN Food Security
- ClinicalTrials.gov ID
- NCT04316819
- Acronym / sponsor ID
- EDECHCNFOODSEC / AG-3198-C-14-0019 (CN FoodSec)
- Conditions
- Food Insecurity Among Children
- Keywords
- Food security, Hunger, School children, Indian Tribal Organization, Home-delivered food box
- 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
- Feb 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 20 Mar 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 Chickasaw Nation.
School districts were matched, and then one was randomly assigned to either a treatment (n=20) or control group (n=20). Treatment households received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. Control households did not receive the treatment benefits but still could participate in other available nutrition assistance programs.
Detailed description
Objective: To reduce childhood food insecurity and hunger, increase families' consumption of nutritious foods, increase the diversity of foods in the home, and ultimately improve diet quality and well-being among children.
Target Population: 40 school districts (115 schools) in 12 counties within the Chickasaw Nation territory in Oklahoma. Within these districts, households with school-age children (both Native American and non-Native American) who were eligible for free school meals or attended a school that participated in the community eligibility provision were eligible to participate in the project.
Intervention School districts were matched, and then one was randomly assigned to either a treatment (n=20) or control group (n=20). Treatment households received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. Control households did not receive the treatment benefits but still could participate in other available nutrition assistance programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Packed Promise Demonstration Benefits | Experimental | Other: Packed Promise Demonstration BenefitsTreatment households (n=2,143) received one food box per eligible child, per month, delivered to the household, which contained (1) shelf-stable foods, including 6 protein-rich items, 2 dairy items, 4 grain foods, 4 cans of fruit, and 12 cans of vegetables; (2) a nutrition education handout (e.g., a recipe); and (3) a $15 Fresh Check for frozen or fresh fruits and vegetables that participants could redeem at any of 38 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-authorized stores or farmers' markets in the study counties. |
| Control Group | No intervention | –Control households (n=2,607) did not receive the treatment benefits but still could participate in other available nutrition assistance programs. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 40 school districts (115 schools) in 12 counties within the Chickasaw Nation territory in Oklahoma.
- Within these districts, households with school-age children (both Native American and non-Native American) who were eligible for free National School Lunch Program meals or attended a school that participated in the community eligibility provision were eligible to participate in the project.
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 |
|---|---|---|
| Packed Promise Demonstration BenefitsMonthly: Home-delivered food box, nutrition education handout, and $15 monthly voucher for fruits and vegetables | Other | Packed Promise 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 20 Mar 2020.
- Derived from this study: PubMed 33342524Briefel RR, Chojnacki GJ, Gabor V, Forrestal SG, Kleinman R, Cabili C, Gleason PM. A Cluster Randomized Controlled Trial of a Home-Delivered Food Box on Food Security in Chickasaw Nation. J Acad Nutr Diet. 2021 Jan;121(1S):S46-S58. doi: 10.1016/j.jand.2020.07.021.
- 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 Packed Promise 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 20 Mar 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 NCT04316819, 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 20 Mar 2020.