NCT04801134

Brief Summary

This is a pilot study to determine how to identify and characterize effective approaches to assist Hispanic families who face food insecurity worsened by the Covid-19 pandemic. The investigators will enroll 50 children with food insecurity who are patients of the largest Federally Qualified Health Center in Austin, Texas. The investigators will follow them for 6 months, providing their caretakers with community resources, food literacy education and assisting them with web sites and applications that they can use to learn about and contact community assistance programs. The investigators will review food insecurity screening, qualitative interviews, dietary assessments, the child's anthropometrics, and standard of care laboratory results. The investigators will schedule follow up phone visits throughout the study to discuss with the families their needs and perceived assistance from the resources provided.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 11, 2021

Last Update Submit

March 18, 2021

Conditions

Food InsecurityChildren, OnlyCovid19

Keywords

Food InsecurityCOVID-19Hispanic Children

Outcome Measures

Primary Outcomes (1)

  • Number of participants with mitigation of food insecurity as assessed by the "Six-item short form of the Household Food Security Scale", a validated 6 item food insecurity screening tool.

    Mitigate food insecurity in participating families by providing education, community resources connections and close and frequent follow ups. Food insecurity will be assessed by the 6 item validated food insecurity screen periodically. The score is a sum of affirmative responses. Two or more affirmative responses indicate food insecurity; 5 or more affirmatives indicate hunger. (citation PMID 10432912)

    6 months

Secondary Outcomes (2)

  • Types of community resources perceived as most helpful by the participants as assessed by a qualitative questionnaire.

    6 months

  • Types of barriers to obtain assistance to alleviate food insecurity perceived by the participants as assessed by a qualitative questionnaire.

    6 months

Other Outcomes (2)

  • Number of participants treated with intervention without evidence of impaired growth rate as measured in infantometer (length) and digital scale (weight).

    6 months

  • Number of participants treated with intervention with evidence of impaired growth rate

    6 months

Study Arms (1)

Food insecurity

OTHER

Food insecure families will be assigned education and community resources needed.

Other: Education

Interventions

EducationOTHER

as per previous description

Also known as: Community Resources
Food insecurity

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Hispanic children, established patients of 2 participating CommUnityCare Clinics (FQHC) in Austin, TX, families that screened positive for food insecurity.

You may not qualify if:

  • non-Hispanic children, families that screen negative for food insecurity, patients that do not receive medical care at the participating CommUnityCare clinics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CommUnityCare Health Center

Austin, Texas, 78753 and 78741, United States

Location

Related Publications (8)

  • Blumberg SJ, Bialostosky K, Hamilton WL, Briefel RR. The effectiveness of a short form of the Household Food Security Scale. Am J Public Health. 1999 Aug;89(8):1231-4. doi: 10.2105/ajph.89.8.1231.

    PMID: 10432912BACKGROUND

  • Shi Q, Castillo F, Viswanathan K, Kupferman F, MacDermid JC. Facilitators and Barriers to Access to Pediatric Medical Services in a Community Hospital. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720904518. doi: 10.1177/2150132720904518.

    PMID: 31997703RESULT

  • Peltz A, Garg A. Food Insecurity and Health Care Use. Pediatrics. 2019 Oct;144(4):e20190347. doi: 10.1542/peds.2019-0347. Epub 2019 Sep 9.

    PMID: 31501238RESULT

  • COUNCIL ON COMMUNITY PEDIATRICS; COMMITTEE ON NUTRITION. Promoting Food Security for All Children. Pediatrics. 2015 Nov;136(5):e1431-8. doi: 10.1542/peds.2015-3301.

    PMID: 26498462RESULT

  • Nicola M, Alsafi Z, Sohrabi C, Kerwan A, Al-Jabir A, Iosifidis C, Agha M, Agha R. The socio-economic implications of the coronavirus pandemic (COVID-19): A review. Int J Surg. 2020 Jun;78:185-193. doi: 10.1016/j.ijsu.2020.04.018. Epub 2020 Apr 17.

    PMID: 32305533RESULT

  • Keenan DP, Olson C, Hersey JC, Parmer SM. Measures of food insecurity/security. J Nutr Educ. 2001;33 Suppl 1:S49-58. doi: 10.1016/s1499-4046(06)60069-9.

    PMID: 12857544RESULT

  • Kaiser LL, Melgar-Quinonez H, Townsend MS, Nicholson Y, Fujii ML, Martin AC, Lamp CL. Food insecurity and food supplies in Latino households with young children. J Nutr Educ Behav. 2003 May-Jun;35(3):148-53. doi: 10.1016/s1499-4046(06)60199-1.

    PMID: 12773286RESULT

  • Matheson DM, Varady J, Varady A, Killen JD. Household food security and nutritional status of Hispanic children in the fifth grade. Am J Clin Nutr. 2002 Jul;76(1):210-7. doi: 10.1093/ajcn/76.1.210.

    PMID: 12081837RESULT

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Educational StatusCommunity Resources

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsHealth Care Economics and Organizations

Study Officials

  • Steven Abrams, MD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Avalos, MD

CONTACT

(512) 502-2347ana.avalos@austin.utexas.edu

Keli Hawthorne, RD

CONTACT

(512)495-4701keli.hawthorne@austin.utexas.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 50 families will be followed over 6 months, providing nutrition education and support with community resources to mitigate the families food insecurity.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 16, 2021

Study Start

March 22, 2021

Primary Completion

March 22, 2022

Study Completion

May 30, 2022

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Patient information may be shared with the study sponsor and/or representative of the sponsor; representatives of UT Austin and the UT Austin Institutional Review Board; Other collaborating organizations (Good Apple, United Way of Central Texas, local food banks, WIC, SNAP). However, we will not share the subjects' data or samples with other researchers for future research studies.

Locations

US(1)