NCT04316819

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

December 12, 2019

Last Update Submit

March 17, 2020

Conditions

Keywords

Food securityHungerSchool childrenIndian Tribal OrganizationHome-delivered food box

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Very Low Food Insecurity among Children

    30 days

  • Food Insecurity among Adults

    30 days

  • Household Food Insecurity

    30 days

  • Food expenditures

    30 days

Study Arms (2)

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.

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.

Interventions

Monthly: Home-delivered food box, nutrition education handout, and $15 monthly voucher for fruits and vegetables

Packed Promise Demonstration Benefits

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Michael P Burke, PhD

    USDA Food and Nutrition Service

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

March 20, 2020

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

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.