- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02700802
Mitigating Hunger and Food Insecurity Among Socioeconomically Disadvantaged Caregivers of Hospitalized Children
May 11, 2017 updated by: University of Chicago
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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,
Exclusion Criteria:
- Caregivers of children in the neonatal intensive care unit (NICU) will be excluded to minimize infectious risk to critically ill newborns and their caregivers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feed1st: Face-to-face provider delivered referral
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.
|
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.
|
|
Experimental: Feed1st: Text message delivered referral
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.
|
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.
|
|
No Intervention: Standard of Care
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline in mental health-related quality of life at 6 months
Time Frame: Baseline, 4-7 days, 3 months, and 6 months
|
Baseline, 4-7 days, 3 months, and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stacy T Lindau, MD, MAPP, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2017
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
March 1, 2016
First Submitted That Met QC Criteria
March 1, 2016
First Posted (Estimate)
March 7, 2016
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- IRB16-1434
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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