Food InsecurityNCT04378595
Assessing Pediatric Food Insecurity During the COVID-19 Pandemic in Austin
An observational study of Food Insecurity, run by University of Texas at Austin at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- During COVID-19 Pandemic and After COVID-19 Pandemic
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Apr 2020to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parent/Caregiver of pediatric patients at 2 specified CommUnity Care centers (Rundberg clinic and Southeast Health and Wellness Clinic)
Who may be able to join
- Any parent/caregiver of a pediatric patient being seen at the 2 specified CommUnity Care centers
Who cannot join
- Not at 2 specified CommUnity Care centers under care of researchers
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Dell Medical School
Austin, Texas, 78715
Keli Hawthorne, MS, 512-495-4700, keli.hawthorne@austin.utexas.edu
Steve Abrams, MD
- Recruiting
CommUnity Care Clinic - Southeast Health and Wellness Clinic
Austin, Texas, 78741
Megan Gray, MD, megan.gray@austin.utexas.edu
Megan Gray, MD
- Recruiting
CommUnity Care Clinic - Rundberg
Austin, Texas, 78753
Ana Avalos, MD, ana.avalos@austin.utexas.edu
Ana Avalos, MD
About this study
Official title: 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.
Read the 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:
- "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?
- "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.
- Conditions
- Food Insecurity
- Being tested
- During COVID-19 Pandemic, After COVID-19 Pandemic
- Keywords
- food insecurity, COVID-19, pandemic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
During COVID-19 PandemicOther
Assessing status of food insecurity during the COVID-19 pandemic
After COVID-19 PandemicOther
Assessing status of food insecurity after the COVID-19 pandemic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: After COVID-19 Pandemic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Insecurity Score
2-questions to assess food insecurity as recommended by the American Academy of Pediatrics:
- "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?
- "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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start10 Apr 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Abrams, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378595
- Sponsor's protocol ID
- 2020-004-0019
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18166558Hager 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.
PubMed 20595453Clay 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.
PubMed 31991735Gattu 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.
PubMed 31581751Abrams 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.
PubMed 32864604
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Pediatric Food Insecurity During the COVID-19 Pandemic in Austin Federally Qualified Health Centers
- ClinicalTrials.gov ID
- NCT04378595
- Acronym / sponsor ID
- 2020-004-0019
- Conditions
- Food Insecurity
- Keywords
- food insecurity, COVID-19, pandemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- "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?
- "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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| During Pandemic | – | Other: During COVID-19 PandemicDuring 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. |
| Post-Pandemic | – | Other: After COVID-19 PandemicPost-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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parent/Caregiver of pediatric patients at 2 specified CommUnity Care centers (Rundberg clinic and Southeast Health and Wellness Clinic)
Key inclusion criteria (1 listed)
- Any parent/caregiver of a pediatric patient being seen at the 2 specified CommUnity Care centers
Key exclusion criteria (1 listed)
- Not at 2 specified CommUnity Care centers under care of researchers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| During COVID-19 PandemicAssessing status of food insecurity during the COVID-19 pandemic | Other | During Pandemic |
| After COVID-19 PandemicAssessing status of food insecurity after the COVID-19 pandemic | Other | Post-Pandemic |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Background: PubMed 18166558Rose-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.
- Background: PubMed 20595453Hager 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.
- Background: PubMed 31991735Clay 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.
- Background: PubMed 31581751Gattu 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.
- Derived from this study: PubMed 32864604Abrams 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.
- AAP Tool Kit for Food InsecurityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Insecurity, run by University of Texas at Austin at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keli Hawthorne (7134163637, keli.hawthorne@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Insecurity Score (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04378595, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.