Health BehaviorNCT02700802
Mitigating Hunger and Food Insecurity Among Socioeconomically Disadvantaged Caregivers of Hospitalized Children
A study testing Feed1st in people with Health Behavior, run by University of Chicago.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Feed1st
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Aug 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- Caregivers of children in the neonatal intensive care unit (NICU) will be excluded to minimize infectious risk to critically ill newborns and their caregivers.
About this study
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.
- Conditions
- Health Behavior
- Being tested
- Feed1st
- Keywords
- food insecurity, informal caregiver health, clinic-to-community linkages, community resources
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mental health-related quality of life at 6 months
Measured: Baseline, 4-7 days, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startJul 2017 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: This research described in this protocol was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy T Lindau, MD, MAPP, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700802
- Sponsor's protocol ID
- IRB16-1434
- Status last verified
- May 2017
- First submitted
- 1 Mar 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Hunger and Food Insecurity Among Socioeconomically Disadvantaged Caregivers of Hospitalized Children
- ClinicalTrials.gov ID
- NCT02700802
- Acronym / sponsor ID
- IRB16-1434
- Conditions
- Health Behavior
- Keywords
- food insecurity, informal caregiver health, clinic-to-community linkages, community resources
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This research described in this protocol was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 7 Mar 2016 (estimated)
- 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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feed1st: Face-to-face provider delivered referral | Experimental | Other: Feed1stIn 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: Text message delivered referral | Experimental | Other: Feed1stIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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,
Key exclusion criteria (1 listed)
- Caregivers of children in the neonatal intensive care unit (NICU) will be excluded to minimize infectious risk to critically ill newborns and their caregivers.
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 |
|---|---|---|
| Feed1stFeed1st 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. | Other | Feed1st: Face-to-face provider delivered referral, Feed1st: Text message delivered referral |
Primary outcome
Change from baseline in mental health-related quality of life at 6 months
Time frame: Baseline, 4-7 days, 3 months, and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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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.
Stacy T Lindau, MD, MAPP principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Feed1st in people with Health Behavior, run by University of Chicago.
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: withdrawn, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mental health-related quality of life at 6 months (time frame: Baseline, 4-7 days, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2017.