NCT02700802

Brief Summary

The Feed1st proposed program of research will promote health of informal caregivers with a hospitalized child by testing a self-management intervention that addresses the widely overlooked problem of caregiver hunger. As many as 54% of parents and other informal caregivers of hospitalized children struggle with insufficient food to nourish themselves and their family during and after a hospital stay. Hunger impairs caregiver physical and mental health by depleting energy for self-care, emotional self-regulation, and supportive interactions with the child, the family, and the formal caregiver team. The long-term objective of the Feed1st program is to alleviate hunger and food insecurity among families with hospitalized children. Established in partnership with nursing and chaplaincy leadership at our children's hospital and the Greater Chicago Food Depository, the Feed1st program currently operates self-serve food pantries on four inpatient units and the emergency department in our children's hospital on Chicago's South Side. Since 2010, Feed1st has provided nearly 8500 pounds of food to at least 4,000 individuals and 1500 households via the self-serve food pantries in the children's hospital. Over this same period, our team has also created a system for efficiently connecting families to community-based resources for hunger and other basic needs.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Status
withdrawn

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

March 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

March 1, 2016

Last Update Submit

May 11, 2017

Conditions

Keywords

food insecurityinformal caregiver healthclinic-to-community linkagescommunity resources

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mental health-related quality of life at 6 months

    Baseline, 4-7 days, 3 months, and 6 months

Study Arms (3)

Feed1st: Face-to-face provider delivered referral

EXPERIMENTAL

In this arm of the study, caregivers will receive usual care and a brief face-to-face referral to the Feed1st program delivered by the provider.

Other: Feed1st

Feed1st: Text message delivered referral

EXPERIMENTAL

In this arm of the study, caregivers will receive usual care and an automated brief text message referral to the Feed1st program from the health care provider. The text message referral will align as closely as possible with the face-to-face referral.

Other: Feed1st

Standard of Care

NO INTERVENTION

Usual care includes passive delivery of information from nursing staff about all available food options in the hospital including the self-serve food pantries in the standard Caregiver FYI Admissions Packet.

Interventions

Feed1stOTHER

Feed1st is a unique hospital-based hunger mitigation program that, since 2010, has operated low-cost, self-serve food pantries at Comer Children's Hospital. All parents and caregivers with a hospitalized child have 24/7 free access to these self-serve pantries with the option to eat food in the pantry, carry out as much food as needed, and contribute back to the pantry with food, volunteerism, or other resources. The program also offers free phone/text/email navigation for food support and other basic needs resources. We aim to conduct a 3-arm, randomized comparative effectiveness study to evaluate the impact, versus usual care, of two alternative referral strategies to increase Feed1st program utilization and impact.

Feed1st: Face-to-face provider delivered referralFeed1st: Text message delivered referral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 18 years of age or older and English speaking, the primary caregiver to a dependent child younger than age 18, have been screened for household food insecurity, reside in the 16 zip code primary service area geography,

You may not qualify if:

  • Caregivers of children in the neonatal intensive care unit (NICU) will be excluded to minimize infectious risk to critically ill newborns and their caregivers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stacy T Lindau, MD, MAPP

    University of Chicago

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 7, 2016

Study Start

July 1, 2017

Primary Completion

September 1, 2020

Study Completion

August 1, 2022

Last Updated

May 12, 2017

Record last verified: 2017-05