CClinicalTrials.gg
CompletedNCT04318873EDECHCNDIETQUpdated Mar 24, 2020

Evaluation of Demonstrations to End Childhood Hunger - CN DietQual

An interventional study of Packed Promise Demonstration Benefits in Diet, Healthy, sponsored by USDA Food and Nutrition Service. Completed. Open to participants aged 4 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by USDA Food and Nutrition Service · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Feb 2016, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
4,750
Allocation
Randomized
Ages
4 Years to 18 Years
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • Diet, Healthy

Keywords

  • Diet quality
  • Children
  • Fruit and vegetable voucher
  • Food box
  • Nutrition assistance
03

In context

Lead sponsor

USDA Food and Nutrition Service is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,750 participants (actual)

Study arms

  • 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.

    Other: Packed Promise Demonstration Benefits

  • 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.

Interventions

  • OtherPacked Promise Demonstration Benefits

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

06

What researchers measure

Primary outcomes

  1. Daily consumed fruits and vegetables

    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.

    Time frame: 30 Days

  2. Daily consumed whole grains

    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.

    Time frame: 30 Days

  3. Daily consumed added sugars

    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.

    Time frame: 30 Days

Secondary outcomes

  1. Food shopping frequency

    Number of times went food shopping

    Time frame: 30 Days

  2. Type of grocery store used

    Types of grocery stores visited to purchase food

    Time frame: 30 Days

  3. Distance traveled from home to grocery stores

    Distance in miles from home to grocery store where food purchsed

    Time frame: 30 Days

  4. Number of family dinners per week

    Number of family dinners per week

    Time frame: 30 Days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Cabili C, Briefel R, Forrestal S, Gabor V, Chojnacki G. A Cluster Randomized Controlled Trial of a Home-Delivered Food Box on Children's Diet Quality in the Chickasaw Nation Packed Promise Project. J Acad Nutr Diet. 2021 Jan;121(1S):S59-S69. doi: 10.1016/j.jand.2020.08.012. PubMed 33342526 ↗

Related links

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04318873
Lead sponsor
USDA Food and Nutrition Service
Collaborators
Mathematica Policy Research, Inc.
Responsible party
Sponsor
First posted
Mar 24, 2020
Start date
Feb 2016
Primary completion
Feb 2018
Completion
Feb 2018
Last update
Mar 24, 2020

Study contacts

Michael Burke, PhD
study director · USDA Food and Nutrition Service

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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