EmpathyNCT02377284
Prevention and Management of Food Allergies
A study testing Photograph in people with Empathy and Food Allergy, run by University of Pennsylvania.
Trial summary
This pilot study will test the use of visual cues to engage food service workers in protecting patrons with food allergies. Food service workers from Philadelphia quick-service restaurants were recruited to participate in a survey of attitudes that includes an embedded randomized experiment testing an experimental cue… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Empathy, Food Allergy
- What is being tested?
- Photograph
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Sep 2014
- 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
- Employed at a quick-service restaurant
- Speaks English
Who cannot join
- Work at a table-only establishment
About this study
Official title: Engaging Food Service Workers in the Prevention of Food Allergy-related Adverse Events
This pilot study will test the use of visual cues to engage food service workers in protecting patrons with food allergies. Food service workers from Philadelphia quick-service restaurants were recruited to participate in a survey of attitudes that includes an embedded randomized experiment testing an experimental cue (photograph of an allergic child) to increase workers' engagement and empathy.
Read the detailed description
Aim: Investigators pilot-tested a novel strategy to engage food service workers, by using a visual cue to increase the workers empathy for and desire to protect the patrons health and safety.
Why intervene with food service workers? Both food allergies and allergenic foods are common, as is eating, making accidental ingestion of allergenic foods almost inevitable. Risks may be particularly pronounced in out-of-home contexts (restaurants, school cafeterias, etc.), where the food allergic person must rely on service workers to assure their safety. Therefore, food service workers are important partners in the prevention of adverse events.
Design: Within the context of a survey of food service workers, investigators embedded a randomized experiment. In this experiment, investigators randomly assigned survey participants to one of two conditions: a Personalized vs. Depersonalized Chef Card. Depersonalized Chef Cards included simple written instructions regarding the patron's specific food allergies, including explicit guidance regarding foods to be avoided and information regarding the seriousness of the allergy. Personalized Chef Cards included identical written instructions and information, as well as a photograph of a patron with food allergies.
Hypothesis: Service workers exposed to the Personalized (compared to Depersonalized) Chef Cards will demonstrate greater empathy, sympathy, willingness to help, and vigilance regarding food allergies and their management.
- Conditions
- Empathy, Food Allergy
- Being tested
- Photograph
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotographOther
Add a photograph to a chef card.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (personalized chef card) | Experimental | Restaurant employees received a personalized chef card, which included written information about a patron's food allergies and a photograph of the patron. Receives: Other: Photograph |
| Control (depersonalized chef card) | No intervention | Restaurant employees received a depersonalized chef card, which included written information about a patron's food allergies, without a photograph of a patron. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean knowledge and attitude scores reported by participants in both study groups
Mean scores (on a scale from 0-100, assessed using a survey) for knowledge and attitudes regarding food allergic patrons among both the intervention and control groups.
Measured: Investigators measured primary outcomes on Day 1 for each participant.
Secondary outcomes (1)
Mean empathy and desire to learn scores reported by participants in both study groups
Mean scores (on a scale from 0-100, assessed using a survey) for willingness to assist patrons with food allergies and desire to learn more about food allergies among both the intervention and control groups.
Measured: Investigators measured secondary outcomes on Day 1 for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmpathyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Cannuscio, University of Pennsylvania
- Investigators
- Carolyn C Cannuscio, ScD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377284
- Sponsor's protocol ID
- 818836
- Status last verified
- Jun 2018
- First submitted
- 6 Feb 2015
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Dupuis R, Meisel Z, Grande D, Strupp E, Kounaves S, Graves A, Frasso R, Cannuscio CC. Food allergy management among restaurant workers in a large U.S. city. Food control 63:147-57, 2016.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Food Service Workers in the Prevention of Food Allergy-related Adverse Events
- ClinicalTrials.gov ID
- NCT02377284
- Acronym / sponsor ID
- 818836
- Conditions
- Empathy, Food Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Mar 2015 (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.
This pilot study will test the use of visual cues to engage food service workers in protecting patrons with food allergies. Food service workers from Philadelphia quick-service restaurants were recruited to participate in a survey of attitudes that includes an embedded randomized experiment testing an experimental cue (photograph of an allergic child) to increase workers' engagement and empathy.
Detailed description
Aim: Investigators pilot-tested a novel strategy to engage food service workers, by using a visual cue to increase the workers empathy for and desire to protect the patrons health and safety.
Why intervene with food service workers? Both food allergies and allergenic foods are common, as is eating, making accidental ingestion of allergenic foods almost inevitable. Risks may be particularly pronounced in out-of-home contexts (restaurants, school cafeterias, etc.), where the food allergic person must rely on service workers to assure their safety. Therefore, food service workers are important partners in the prevention of adverse events.
Design: Within the context of a survey of food service workers, investigators embedded a randomized experiment. In this experiment, investigators randomly assigned survey participants to one of two conditions: a Personalized vs. Depersonalized Chef Card. Depersonalized Chef Cards included simple written instructions regarding the patron's specific food allergies, including explicit guidance regarding foods to be avoided and information regarding the seriousness of the allergy. Personalized Chef Cards included identical written instructions and information, as well as a photograph of a patron with food allergies.
Hypothesis: Service workers exposed to the Personalized (compared to Depersonalized) Chef Cards will demonstrate greater empathy, sympathy, willingness to help, and vigilance regarding food allergies and their management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (personalized chef card) | Experimental | Other: PhotographRestaurant employees received a personalized chef card, which included written information about a patron's food allergies and a photograph of the patron. |
| Control (depersonalized chef card) | No intervention | –Restaurant employees received a depersonalized chef card, which included written information about a patron's food allergies, without a photograph of a patron. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employed at a quick-service restaurant
- Speaks English
Key exclusion criteria (1 listed)
- Work at a table-only establishment
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 |
|---|---|---|
| PhotographAdd a photograph to a chef card. | Other | Intervention (personalized chef card) |
Primary outcome
Mean knowledge and attitude scores reported by participants in both study groups
Time frame: Investigators measured primary outcomes on Day 1 for each participant.
Mean scores (on a scale from 0-100, assessed using a survey) for knowledge and attitudes regarding food allergic patrons among both the intervention and control groups.
1 secondary outcome
Mean empathy and desire to learn scores reported by participants in both study groups
Time frame: Investigators measured secondary outcomes on Day 1 for each participant.
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 15 Jun 2018.
- Results publicationDupuis R, Meisel Z, Grande D, Strupp E, Kounaves S, Graves A, Frasso R, Cannuscio CC. Food allergy management among restaurant workers in a large U.S. city. Food control 63:147-57, 2016.
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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.
Carolyn C Cannuscio, ScD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Photograph in people with Empathy and Food Allergy, run by University of Pennsylvania.
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 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: finished, as of the sponsor's last update on 15 Jun 2018. 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 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?
Mean knowledge and attitude scores reported by participants in both study groups (time frame: Investigators measured primary outcomes on Day 1 for each participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377284, which also lists 1 linked publication.
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 15 Jun 2018.