HungerNCT03656146
Food for Thought: Food Insecurity Screening in the Emergency Department
A study testing Food Insecurity Screening Tablet and Food Insecurity Screening Verbal in people with Hunger and Child Nutrition Disorders, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study compares food insecurity disclosure rates in face-to-face interviews versus electronic formats, and explores caregiver preferences regarding screening modality and location, in a large, urban pediatric emergency department. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hunger, Child Nutrition Disorders
- What is being tested?
- Food Insecurity Screening Tablet and Food Insecurity Screening Verbal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,818 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 18 Jan 2018
- 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
- English speaking
- Adult caregiver accompanying pediatric patient in the Children's Hospital of Philadelphia (CHOP) emergency department
Who cannot join
- Patient (child) in critical condition
- Patient (child) >18 years of age
- Previously enrolled in study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Food for Thought: A Randomized Trial of Food Insecurity Screening in the Emergency Department
This study compares food insecurity disclosure rates in face-to-face interviews versus electronic formats, and explores caregiver preferences regarding screening modality and location, in a large, urban pediatric emergency department. Half of the participants were screened for food insecurity verbally, face-to-face by a research assistant, and half of the participants were screened electronically by a tablet.
Read the detailed description
Children are disproportionately affected by the rise in poverty rates in the United States, and economic hardships can compromise their development, negatively affect their overall health, and adversely affect their abilities to succeed in school and in life. Food insecurity (FI)-the limited or uncertain availability of nutritionally adequate or safe foods- while strongly associated with poverty, is an independent predictor of poor health outcomes for children.
The Emergency Department (ED) of academic medical centers often serves as a point of care entry for impoverished and high-risk families. Although there is a growing interest in the healthcare system's ability to address Social Determinants of Health (SDH), little is known about food insecurity in the pediatric ED. Additionally, there are limited data on how to implement FI screening into practice in a way that maximizes elicitation of social need, while assuring patient and family comfort.
- Conditions
- Hunger, Child Nutrition Disorders
- Being tested
- Food Insecurity Screening Tablet, Food Insecurity Screening Verbal
- Keywords
- social determinants of health, food insecurity, screening, pediatrics
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Insecurity Screening TabletOther
The intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening
Food Insecurity Screening VerbalOther
The intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening
| Study group | Role | What they receive |
|---|---|---|
| Tablet Screening | Active comparator | Food insecurity screening conducted via electronic tablet Receives: Other: Food Insecurity Screening Tablet |
| Verbal Screening | Active comparator | Food insecurity screening conducted via verbal face-to-face interview Receives: Other: Food Insecurity Screening Verbal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Food Insecurity
Affirmative response to either of the two, validated screening questions for food insecurity. Investigators measured food insecurity using the validated two-question "Hunger Vital Sign" screening tool, with yes/no responses. These two questions are: within the past 12 months "we worried whether our food would run out before we got money to buy more" and "the food we bought just didn't last and we didn't have money to get more."
Measured: 12 months
Secondary outcomes (2)
Preferred Screening Modality
Report of screening modality preference: verbal, tablet, or no preference
Measured: 4 weeks
Comfort level with screening location
Report of comfort with screening in the emergency department and in the primary care setting
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start15 May 2017
- Primary completion28 Nov 2017
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HungerStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656146
- Sponsor's protocol ID
- 17-013696
- Status last verified
- Mar 2023
- First submitted
- 28 Aug 2018
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food for Thought: A Randomized Trial of Food Insecurity Screening in the Emergency Department
- ClinicalTrials.gov ID
- NCT03656146
- Acronym / sponsor ID
- 17-013696
- Conditions
- Hunger, Child Nutrition Disorders
- Keywords
- social determinants of health, food insecurity, screening, pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,818 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 15 May 2017 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 4 Sep 2018 (actual)
- 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.
This study compares food insecurity disclosure rates in face-to-face interviews versus electronic formats, and explores caregiver preferences regarding screening modality and location, in a large, urban pediatric emergency department. Half of the participants were screened for food insecurity verbally, face-to-face by a research assistant, and half of the participants were screened electronically by a tablet.
Detailed description
Children are disproportionately affected by the rise in poverty rates in the United States, and economic hardships can compromise their development, negatively affect their overall health, and adversely affect their abilities to succeed in school and in life. Food insecurity (FI)-the limited or uncertain availability of nutritionally adequate or safe foods- while strongly associated with poverty, is an independent predictor of poor health outcomes for children.
The Emergency Department (ED) of academic medical centers often serves as a point of care entry for impoverished and high-risk families. Although there is a growing interest in the healthcare system's ability to address Social Determinants of Health (SDH), little is known about food insecurity in the pediatric ED. Additionally, there are limited data on how to implement FI screening into practice in a way that maximizes elicitation of social need, while assuring patient and family comfort.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet Screening | Active comparator | Other: Food Insecurity Screening TabletFood insecurity screening conducted via electronic tablet |
| Verbal Screening | Active comparator | Other: Food Insecurity Screening VerbalFood insecurity screening conducted via verbal face-to-face interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- Adult caregiver accompanying pediatric patient in the Children's Hospital of Philadelphia (CHOP) emergency department
Key exclusion criteria (3 listed)
- Patient (child) in critical condition
- Patient (child) >18 years of age
- Previously enrolled in study
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 |
|---|---|---|
| Food Insecurity Screening TabletThe intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening | Other | Tablet Screening |
| Food Insecurity Screening VerbalThe intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening | Other | Verbal Screening |
Primary outcome
Presence of Food Insecurity
Time frame: 12 months
Affirmative response to either of the two, validated screening questions for food insecurity. Investigators measured food insecurity using the validated two-question "Hunger Vital Sign" screening tool, with yes/no responses. These two questions are: within the past 12 months "we worried whether our food would run out before we got money to buy more" and "the food we bought just didn't last and we didn't have money to get more."
2 secondary outcomes
Preferred Screening Modality
Time frame: 4 weeks
Comfort level with screening location
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Hunger
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study
Healthy Participants, Healthy Adult Subject
Recruiting
Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study
Healthy Participants, Healthy Adult Subject
Active, not recruiting
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation
Recruiting
Assessing the Relationships Between Parent-child Eating in the Absence of Hunger, Appetitive Traits, and Food Parenting.
Eating in Absence of Hunger, Food Parenting
Recruiting
Evaluation of the Effectiveness of Nutritional Supplement Packages on Improving School Children's Hunger, Eating Behavior and Classroom Concentration
Classroom Concentration, Dietary Diversity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Insecurity Screening Tablet and Food Insecurity Screening Verbal in people with Hunger and Child Nutrition Disorders, run by Children's Hospital of Philadelphia at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of Food Insecurity (time frame: 12 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 16 Mar 2023.