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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04316819
Other study ID # AG-3198-C-14-0019 (CN FoodSec)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date February 2018

Study information

Verified date March 2020
Source USDA Food and Nutrition Service
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4750
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Packed Promise Demonstration Benefits
Monthly: Home-delivered food box, nutrition education handout, and $15 monthly voucher for fruits and vegetables

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
USDA Food and Nutrition Service Mathematica

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
30 days
Secondary 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.
30 days
Secondary 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.
30 days
Secondary 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.
30 days
Secondary Food expenditures Total amount of Supplemental Nutrition Assistance Program (SNAP) and out-of-pocket food purchases in dollars. 30 days
See also
  Status Clinical Trial Phase
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Completed NCT04253743 - Evaluation of Demonstrations to End Childhood Hunger - NV N/A
Completed NCT04283344 - Evaluation of Demonstrations to End Childhood Hunger - KY N/A
Completed NCT02877147 - The Evaluation of the Summer EBT for Children Demonstration N/A

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