- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04318873
Evaluation of Demonstrations to End Childhood Hunger - CN DietQual (EDECHCNDIETQ)
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
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
- 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
Sponsor
Collaborators
Investigators
- Study Director: Michael Burke, PhD, USDA Food and Nutrition Service
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 DietQ)
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
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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