NCT04739540

Brief Summary

Food insecurity (FI), limited access to food due to a lack of money or other resources, affected an estimated 14% households with children in the US in 2018. Multiple national organizations, including the American Academy of Pediatrics (AAP), have identified adverse childhood outcomes that are strongly correlated with FI, and the AAP recommends that physicians universally screen for and address FI, but screening for FI has primarily been addressed in the outpatient setting. Recent data demonstrates rising FI needs related to COVID-19 pandemic. There is limited information regarding screening and interventions for inpatient FI, defined as the inability to obtain adequate food during hospitalization. Previous work performed a cross-sectional study of 200 caregivers of hospitalized children in Chicago, Illinois, estimated the prevalence of inpatient FI to be 32%. Locally, work by Drs. Alice Lee, Lopez, and Bocchini identified hospital food insecurity (FI) in 43% of the caregivers of hospitalized children (Lee, Alice, et al. "Food Insecurity in the Caregivers of Hospitalized Pediatric Patients." Pediatrics 2018: 481-481.) . The investigators also found a strong association between inpatient and household food insecurity. Hospital food insecurity has a profound effect on caregiver's ability to participate in caring for their children during the hospitalization. Currently, there is not a valid screening tool to address inpatient food insecurity and there is a paucity of data on the effects of FI interventions implemented in the hospital setting. Additionally, there is new data from the COVID Impact Survey and The Hamilton Project/Future of the Middle Class Initiative Survey of Mothers with Young Children demonstrating that FI prevalence has more than doubled in household with children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,009

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 11, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

January 13, 2021

Last Update Submit

June 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Food Insecurity

    The primary outcome is prevalence of food insecurity.

    Up to 3 weeks

Secondary Outcomes (1)

  • Percentage of Patients Enrolled in Food Insecurity

    6 months

Eligibility Criteria

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

Primary caregiver that is defined as the parent or legal representative who self identifies as a primary caregiver for the child.

You may qualify if:

  • Primary caregiver (parent or legal representative who self-identifies as a primary caregiver) of a child admitted to West Tower acute care floors 12th, 14th and 15th at Texas Childrens Hospital Medical Center Campus. Study procedures will not involve the child directly.
  • Age \> 18 years old.
  • English or Spanish speaking
  • Hospital day 3 or greater

You may not qualify if:

  • Caregiver at bedside is not the primary caregiver of the child as confirmed at time of informed consent.
  • Previous enrollment on this study.
  • Adolescent and Rehabilitation designated beds on 14th and 12th floors respectively.
  • Confirmed COVID-19 positive patients under enhanced respiratory precautions because the caregivers for these patients are receiving food trays provided to them by the unit. (Caregivers of patients who are under investigation for COVID will not be enrolled until after the test is negative.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Study Officials

  • Michelle Lopez, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistance Professor Pediatrics- Hospital Medicine

Study Record Dates

First Submitted

January 13, 2021

First Posted

February 4, 2021

Study Start

March 11, 2021

Primary Completion

April 1, 2022

Study Completion

April 27, 2022

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations