Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318873
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Mathematica
Information provided by (Responsible Party):
USDA Food and Nutrition Service

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 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.


Condition or disease Intervention/treatment Phase
Diet, Healthy Other: Packed Promise Demonstration Benefits Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Demonstrations to End Childhood Hunger - CN DietQual
Actual Study Start Date : February 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

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.
Other: Packed Promise Demonstration Benefits
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.



Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



Secondary Outcome Measures :
  1. Food shopping frequency [ Time Frame: 30 Days ]
    Number of times went food shopping

  2. Type of grocery store used [ Time Frame: 30 Days ]
    Types of grocery stores visited to purchase food

  3. Distance traveled from home to grocery stores [ Time Frame: 30 Days ]
    Distance in miles from home to grocery store where food purchsed

  4. Number of family dinners per week [ Time Frame: 30 Days ]
    Number of family dinners per week



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318873


Sponsors and Collaborators
USDA Food and Nutrition Service
Mathematica
Investigators
Layout table for investigator information
Study Director: Michael Burke, PhD USDA Food and Nutrition Service
Additional Information:
Layout table for additonal information
Responsible Party: USDA Food and Nutrition Service
ClinicalTrials.gov Identifier: NCT04318873    
Other Study ID Numbers: AG-3198-C-14-0019 (CN DietQ)
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by USDA Food and Nutrition Service:
Diet quality
Children
Fruit and vegetable voucher
Food box
Nutrition assistance