- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04316819
Evaluation of Demonstrations to End Childhood Hunger - CN Food Sec (EDECHCNFOODSEC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Packed Promise Demonstration Benefits
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.
|
Monthly: Home-delivered food box, nutrition education handout, and $15 monthly voucher for fruits and vegetables
|
|
No Intervention: Control Group
Control households (n=2,607) did not receive the treatment benefits but still could participate in other available nutrition assistance programs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Very Low Food Insecurity among Children
Time Frame: 30 days
|
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. |
30 days
|
|
Food Insecurity among Adults
Time Frame: 30 days
|
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. |
30 days
|
|
Household Food Insecurity
Time Frame: 30 days
|
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. |
30 days
|
|
Food expenditures
Time Frame: 30 days
|
Total amount of Supplemental Nutrition Assistance Program (SNAP) and out-of-pocket food purchases in dollars.
|
30 days
|
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
Other Study ID Numbers
- AG-3198-C-14-0019 (CN FoodSec)
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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