Assessing Pediatric Food Insecurity During the COVID-19 Pandemic in Austin

May 6, 2020 updated by: Steven Abrams, University of Texas at Austin

Assessing Pediatric Food Insecurity During the COVID-19 Pandemic in Austin Federally Qualified Health Centers

The investigators suspect that the current COVID-19 pandemic may be associated with a high level of unsuspected food insecurity among lower income Austin families who receive their health care at a Federally Qualified Health Center (FQHC). Pediatricians will ask families about food insecurity as part of standard of care in order to assess if food insecurity has begun or worsened during the pandemic.

Study Overview

Detailed Description

According to previous studies, 21-23% of lower income families experience food insecurity, a position of uncertainty about their ability to afford food or omitting meals for financial reasons. Food insecurity in a family is detrimental to a child's mental and physical health, and poses a risk to his/her development. Food insecurity prevalence has also been reported higher than the state level prevalence in households impacted by disasters. It is therefore reasonable to hypothesize that the unprecedented global COVID-19 pandemic has increased the frequency of food insecurity among lower income families. However, no data are known about the current incidence of food insecurity during a pandemic with quarantine procedures in place. This knowledge will also add background for future studies on the effects of acute on chronic food insecurity on low-income families facing similar adversities such as this epidemic.

A 2-question tool has been validated to evaluate the presence of food insecurity. An affirmative response to either question has been reported to yield a sensitivity of 97% and specificity of 83-86%. Screening for basic needs may open a sensitive discussion about economic difficulties associated with the adverse health outcomes previously discussed. While this tool is a current standard of care as recommended by the American Academy of Pediatrics, it is often not utilized in medical visits to a primary care provider whether for routine well child care or for sick visits. During the study period, pediatricians at two FQHC clinics will make a concentrated effort to ask these 2 screening questions in order to collect data on the prevalence and magnitude of challenges of food insecurity at this time.

Although the investigators are seeking to evaluate the current standard of care, they may want to share our findings in order to provide a foundation for more generalizable research.

The investigators will seek to take a random sampling of 500 pediatric patients (250 each from 2 CommUnity Care clinics) and query the parent/guardian with the 2-question food insecurity tool during their regular appointment, either in person or on the phone/telehealth. The pediatricians (Co-Inv) will ask the questions and record the data.

2-questions to assess food insecurity as recommended by the American Academy of Pediatrics:

  1. "We worried whether our food would run out before we got money to buy more." Was that often true, sometimes true, or never true for your household in the last 12 months?
  2. "The food we bought just didn't last, and we didn't have money to get more." Was that often true, sometimes true, or never true for your household in the last 12 months? A response of "often true" or "sometimes true" to either question = positive screen for Food Insecurity.

The investigators will also ask the same 2 questions in the framework of "…in the last 1-2 months" to assess how the current situation has affected their immediate concerns. If the parent/guardian response with a positive screen for food insecurity, the pediatrician will refer the families to available community resources as is the usual standard of care.

The investigators will not record any identifiable information. This is not a longitudinal study. In 4-6 months the investigators will repeat this procedure with another, different random sampling of 500 patients to assess any long lasting effects of the COVID-19 pandemic or to determine if the immediate food crisis due to the pandemic has passed. The investigators requested a waiver of consent for this project.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Austin, Texas, United States, 78715
        • Recruiting
        • Dell Medical School
        • Principal Investigator:
          • Steve Abrams, MD
      • Austin, Texas, United States, 78741
      • Austin, Texas, United States, 78753

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parent/Caregiver of pediatric patients at 2 specified CommUnity Care centers (Rundberg clinic and Southeast Health and Wellness Clinic)

Description

Inclusion Criteria:

  • Any parent/caregiver of a pediatric patient being seen at the 2 specified CommUnity Care centers

Exclusion Criteria:

  • Not at 2 specified CommUnity Care centers under care of researchers

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
During Pandemic
During Pandemic: The investigators will query the parent/guardian with the 2-question food insecurity validated tool during their regular appointment, either in person or on the phone/telehealth. If a positive response is given, the investigators will ask if the food insecurity began or worsened during the pandemic in the past 1 to 2 months.
Assessing status of food insecurity during the COVID-19 pandemic
Post-Pandemic
Post-Pandemic: The investigators will query the parent/guardian with the 2-question food insecurity validated tool during their regular appointment, either in person or on the phone/telehealth. The investigators will assess if food insecurity has stopped or lessened after the pandemic.
Assessing status of food insecurity after the COVID-19 pandemic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Insecurity Score
Time Frame: Up to 1 year

2-questions to assess food insecurity as recommended by the American Academy of Pediatrics:

  1. "We worried whether our food would run out before we got money to buy more." Was that often true, sometimes true, or never true for your household in the last 12 months?
  2. "The food we bought just didn't last, and we didn't have money to get more." Was that often true, sometimes true, or never true for your household in the last 12 months? A response of "often true" or "sometimes true" to either question = positive screen for Food Insecurity.

The investigators will also ask the same 2 questions in the framework of "…in the last 1-2 months" to assess how the current situation has affected their immediate concerns, assessing if their food insecurity has begun or worsened during the pandemic.

Up to 1 year

Collaborators and Investigators

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

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.

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)

April 10, 2020

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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