NCT04378595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

May 5, 2020

Last Update Submit

May 6, 2020

Conditions

Keywords

food insecurityCOVID-19pandemic

Outcome Measures

Primary Outcomes (1)

  • Food Insecurity Score

    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

Study Arms (2)

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

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

Interventions

Assessing status of food insecurity during the COVID-19 pandemic

During Pandemic

Assessing status of food insecurity after the COVID-19 pandemic

Post-Pandemic

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dell Medical School

Austin, Texas, 78715, United States

RECRUITING

CommUnity Care Clinic - Southeast Health and Wellness Clinic

Austin, Texas, 78741, United States

RECRUITING

CommUnity Care Clinic - Rundberg

Austin, Texas, 78753, United States

RECRUITING

Related Publications (5)

  • Rose-Jacobs R, Black MM, Casey PH, Cook JT, Cutts DB, Chilton M, Heeren T, Levenson SM, Meyers AF, Frank DA. Household food insecurity: associations with at-risk infant and toddler development. Pediatrics. 2008 Jan;121(1):65-72. doi: 10.1542/peds.2006-3717.

    PMID: 18166558BACKGROUND
  • Hager ER, Quigg AM, Black MM, Coleman SM, Heeren T, Rose-Jacobs R, Cook JT, Ettinger de Cuba SA, Casey PH, Chilton M, Cutts DB, Meyers AF, Frank DA. Development and validity of a 2-item screen to identify families at risk for food insecurity. Pediatrics. 2010 Jul;126(1):e26-32. doi: 10.1542/peds.2009-3146.

    PMID: 20595453BACKGROUND
  • Clay LA, Ross AD. Factors Associated with Food Insecurity Following Hurricane Harvey in Texas. Int J Environ Res Public Health. 2020 Jan 25;17(3):762. doi: 10.3390/ijerph17030762.

    PMID: 31991735BACKGROUND
  • Gattu RK, Paik G, Wang Y, Ray P, Lichenstein R, Black MM. The Hunger Vital Sign Identifies Household Food Insecurity among Children in Emergency Departments and Primary Care. Children (Basel). 2019 Oct 2;6(10):107. doi: 10.3390/children6100107.

    PMID: 31581751BACKGROUND
  • Abrams SA, Avalos A, Gray M, Hawthorne KM. High Level of Food Insecurity among Families with Children Seeking Routine Care at Federally Qualified Health Centers during the Coronavirus Disease 2019 Pandemic. J Pediatr X. 2020 Fall;4:100044. doi: 10.1016/j.ympdx.2020.100044. Epub 2020 Jun 22.

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 7, 2020

Study Start

April 10, 2020

Primary Completion

December 30, 2020

Study Completion

July 30, 2021

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations