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

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ClinicalTrials.gov Identifier: NCT04378595
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Steven Abrams, University of Texas at Austin

Brief Summary:
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.

Condition or disease Intervention/treatment
Food Insecurity Other: During COVID-19 Pandemic Other: After COVID-19 Pandemic

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Pediatric Food Insecurity During the COVID-19 Pandemic in Austin Federally Qualified Health Centers
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : July 30, 2021

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.
Other: During COVID-19 Pandemic
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.
Other: After COVID-19 Pandemic
Assessing status of food insecurity after the COVID-19 pandemic




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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

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): NCT04378595


Contacts
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Contact: Keli Hawthorne 7134163637 keli.hawthorne@austin.utexas.edu

Locations
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United States, Texas
Dell Medical School Recruiting
Austin, Texas, United States, 78715
Contact: Keli Hawthorne, MS    512-495-4700    keli.hawthorne@austin.utexas.edu   
Principal Investigator: Steve Abrams, MD         
CommUnity Care Clinic - Southeast Health and Wellness Clinic Recruiting
Austin, Texas, United States, 78741
Contact: Megan Gray, MD       megan.gray@austin.utexas.edu   
Principal Investigator: Megan Gray, MD         
CommUnity Care Clinic - Rundberg Recruiting
Austin, Texas, United States, 78753
Contact: Ana Avalos, MD       ana.avalos@austin.utexas.edu   
Principal Investigator: Ana Avalos, MD         
Sponsors and Collaborators
University of Texas at Austin
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Steven Abrams, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04378595    
Other Study ID Numbers: 2020-004-0019
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steven Abrams, University of Texas at Austin:
food insecurity
COVID-19
pandemic