Evaluation of Demonstrations to End Childhood Hunger - CN DietQual (EDECHCNDIETQ)

March 20, 2020 updated by: USDA Food and Nutrition Service

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 and the diet quality of child participants.

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

4750

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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
Daily consumed fruits and vegetables
Time Frame: 30 Days

The dietary measures used the food frequency questions developed for the 2009-2010 National Health and Nutrition Examination Survey (NHANES) Dietary Screener Questionnaire. For these questions, parents or guardians were asked how often (per day, per week, or per month) a randomly selected child (age 2 or older) in the household consumed food and beverages from 19 categories during the last 30 days.

The National Cancer Institute's (NCI's) Dietary Screener Questionnaire data processing and scoring procedures were used to convert parent and caregiver reports of their child's daily, weekly, and monthly consumption into standardized daily amounts. Higher scores indicate higher consumption of the food item.

30 Days
Daily consumed whole grains
Time Frame: 30 Days

The dietary measures used the food frequency questions developed for the 2009-2010 National Health and Nutrition Examination Survey (NHANES) Dietary Screener Questionnaire. For these questions, parents or guardians were asked how often (per day, per week, or per month) a randomly selected child (age 2 or older) in the household consumed food and beverages from 19 categories during the last 30 days.

The National Cancer Institute's (NCI's) Dietary Screener Questionnaire data processing and scoring procedures were used to convert parent and caregiver reports of their child's daily, weekly, and monthly consumption into standardized daily amounts. Higher scores indicate higher consumption of the food item.

30 Days
Daily consumed added sugars
Time Frame: 30 Days

The dietary measures used the food frequency questions developed for the 2009-2010 National Health and Nutrition Examination Survey (NHANES) Dietary Screener Questionnaire. For these questions, parents or guardians were asked how often (per day, per week, or per month) a randomly selected child (age 2 or older) in the household consumed food and beverages from 19 categories during the last 30 days.

The National Cancer Institute's (NCI's) Dietary Screener Questionnaire data processing and scoring procedures were used to convert parent and caregiver reports of their child's daily, weekly, and monthly consumption into standardized daily amounts. Higher scores indicate higher consumption of the food item.

30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food shopping frequency
Time Frame: 30 Days
Number of times went food shopping
30 Days
Type of grocery store used
Time Frame: 30 Days
Types of grocery stores visited to purchase food
30 Days
Distance traveled from home to grocery stores
Time Frame: 30 Days
Distance in miles from home to grocery store where food purchsed
30 Days
Number of family dinners per week
Time Frame: 30 Days
Number of family dinners per week
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Michael Burke, PhD, USDA Food and Nutrition Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

March 20, 2020

First Posted (ACTUAL)

March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AG-3198-C-14-0019 (CN DietQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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