Food AllergyNCT03284372
Safer Food Allergy Management for Adolescents
A study testing Text Message Only and Text message + Incentive 1 in people with Food Allergy and Adherence, Medication, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Among the 15 million people with food allergies in the U.S., adolescents experience the highest risk of adverse events. Yet, there are few evidence-based strategies to improve food allergy management in adolescents. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Food Allergy, Adherence, Medication
- What is being tested?
- Text Message Only and Text message + Incentive 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jan 2018to 31 Jul 2020
- 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 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Food allergy diagnosis by a physician and recorded in the medical chart
- Prior prescription of epinephrine auto-injector to treat anaphylaxis
- Access to a cell phone capable of sending and receiving text messages and photographs (our team will provide cell phones to participants willing to participate, but who do not own a cellphone)
- Fluent in English
- Between ages 15-19 at baseline
Who cannot join
- Unable to obtain permission (consent) of a parent to participate in the study
- Will not or cannot give assent
- Currently participating in another clinical trial with related aims
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Among the 15 million people with food allergies in the U.S., adolescents experience the highest risk of adverse events. Yet, there are few evidence-based strategies to improve food allergy management in adolescents. In a cohort multiple randomized controlled trial, this study will include two experiments to test the effectiveness of text message reminders and incentives to encourage epinephrine-carrying.
Read the detailed description
Among the 15 million people with food allergies in the United States, adolescents experience the highest risk of adverse events, including death from anaphylaxis. Visits to one pediatric emergency department for anaphylaxis doubled between 2001 and 2006, suggesting a rapidly escalating public health burden. Despite this critical concern, there are few evidence-based strategies to improve food allergy management in adolescents, who must sustain three core prevention strategies: diligent avoidance of allergenic foods, consistent carrying of potentially life-saving epinephrine auto-injectors, and prompt administration of epinephrine in the event of anaphylaxis.
The objective of this study is to develop and test interventions to encourage safer food allergy management among adolescents. The primary outcome is consistency of epinephrine-carrying, measured using cell phone photographs at randomly-timed check-ins. This study will be among the first to longitudinally track normative food allergy management practices and one of the first to test behavior change strategies.
In a cohort multiple randomized controlled trial (n=130), the study will include two experiments to test the effectiveness of text message reminders and incentives, using various incentive designs that have proven effective in prior behavioral economics interventions to encourage weight loss and smoking cessation. Aim 1. Test the impact of a text-message reminder system on consistency of epinephrine carrying. Aim 2. Test the impact of modest incentives on consistency of epinephrine carrying. Based on promising preliminary data, the central hypothesis is that, compared to controls, adolescents who receive text message reminders plus modest financial incentives will more consistently carry their epinephrine.
- Conditions
- Food Allergy, Adherence, Medication
- Being tested
- Text Message Only, Text message + Incentive 1
- Medical subject headings
- Food Hypersensitivity, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message OnlyBehavioural
The intervention group (n=25, randomly selected from the base cohort) will receive informational and socially supportive text messages during a 10-week intervention. Investigators will deploy the intervention using the Way to Health platform, which automates outgoing messages and feedback. Many of the messages will be sent to all Intervention 1 participants, to assure consistency of the intervention. A subset will be tailored to address participants' specific allergies. At 10 unannounced check-ins, we will send text messages asking participants in the intervention and control groups if they are carrying their epinephrine.
Text message + Incentive 1Behavioural
Among base cohort members not exposed to the text message only intervention (#1), we will randomly select a new intervention group (n=50) to receive text message reminders plus Incentive 1. At each of 10 unannounced check-ins, if unsuccessful in documenting epinephrine-carrying, participants will lose part of their incentive. The remainder of the Cohort (control) will receive text reminders.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | Text Message Only Receives: Behavioral: Text Message Only |
| Intervention 2, Incentive | Experimental | Text message + Incentive Receives: Behavioral: Text message + Incentive 1 |
| Cohort | No intervention | For the cohort multiple randomized controlled trial (cmRCT), investigators will recruit 130 participants (the base cohort) ages 15-19. The base cohort allows investigators to measure normative food allergy self-management practices, while also serving as a control for experiments in Interventions 1 and 2. |
| Control | No intervention | The baseline cohort serves as the control group in this cmRCT. Participants will not receive text message reminders (during Intervention 1) or incentives (during Intervention 2). However, they will participate in all data collection points, including text message check-ins to assess epinephrine-carrying. Participants in the base cohort will receive usual care. |
| Adolescent Allergy Advisors | No intervention | We will pilot the text messages to be used in Interventions 1 and 2 through interviews and cognitive testing among 20 Adolescent Allergy Advisors, who will critique message content, framing, and language. These advisors will not be part of the cohort multiple randomized controlled trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of check-ins at which participant is carrying epinephrine auto-injector
Proportion of check-ins at which participant is carrying epinephrine auto-injector, measured using cell phone photographs
Measured: 10 randomly timed check-ins during the 10-week intervention period
Secondary outcomes (3)
Characterize adolescents' normative food allergy management practices
Characterize adolescents' normative food allergy management practices, measured comparing baseline and follow-up surveys that assess social challenges, out-of-home eating, allergen avoidance, and response to adverse events.
Measured: Year-long cohort study
Characterize adolescents' normative food allergy management practices
Characterize adolescents' normative food allergy management practices, measured using periodic text-message questions that assess social challenges, out-of-home eating, allergen avoidance, and response to adverse events.
Measured: Year-long cohort study
Develop a set of text message reminders to promote safer food allergy management among adolescents
Develop a set of text message reminders to promote safer food allergy management among adolescents by cognitively testing text message content
Measured: 2-year project period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start18 Jan 2018
- Primary completion18 Jan 2020
- Study completion31 Jul 2020
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 Food AllergyStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Carolyn C Cannuscio, ScD, Principal investigator, University of PennsylvaniaJonathan Spergel, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284372
- Sponsor's protocol ID
- 827073
- Status last verified
- Mar 2021
- First submitted
- 7 Sep 2017
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dupuis R, Spergel JM, Brown-Whitehorn TF, Troxel AB, Kenney EL, Block JP, Feuerstein-Simon R, Marti XL, Mollen CJ, Meisel ZF, Volpp KG, Gortmaker SL, Cannuscio CC. Incidence of food allergic reactions among adolescents engaged in food allergy management. Ann Allergy Asthma Immunol. 2025 Jun;134(6):719-723.e2. doi: 10.1016/j.anai.2025.02.023. Epub 2025 Mar 9.
PubMed 40068800
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Food Allergy Management for Adolescents
- ClinicalTrials.gov ID
- NCT03284372
- Acronym / sponsor ID
- 827073
- Conditions
- Food Allergy, Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 18 Jan 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 Sep 2017 (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.
Among the 15 million people with food allergies in the U.S., adolescents experience the highest risk of adverse events. Yet, there are few evidence-based strategies to improve food allergy management in adolescents. In a cohort multiple randomized controlled trial, this study will include two experiments to test the effectiveness of text message reminders and incentives to encourage epinephrine-carrying.
Detailed description
Among the 15 million people with food allergies in the United States, adolescents experience the highest risk of adverse events, including death from anaphylaxis. Visits to one pediatric emergency department for anaphylaxis doubled between 2001 and 2006, suggesting a rapidly escalating public health burden. Despite this critical concern, there are few evidence-based strategies to improve food allergy management in adolescents, who must sustain three core prevention strategies: diligent avoidance of allergenic foods, consistent carrying of potentially life-saving epinephrine auto-injectors, and prompt administration of epinephrine in the event of anaphylaxis.
The objective of this study is to develop and test interventions to encourage safer food allergy management among adolescents. The primary outcome is consistency of epinephrine-carrying, measured using cell phone photographs at randomly-timed check-ins. This study will be among the first to longitudinally track normative food allergy management practices and one of the first to test behavior change strategies.
In a cohort multiple randomized controlled trial (n=130), the study will include two experiments to test the effectiveness of text message reminders and incentives, using various incentive designs that have proven effective in prior behavioral economics interventions to encourage weight loss and smoking cessation. Aim 1. Test the impact of a text-message reminder system on consistency of epinephrine carrying. Aim 2. Test the impact of modest incentives on consistency of epinephrine carrying. Based on promising preliminary data, the central hypothesis is that, compared to controls, adolescents who receive text message reminders plus modest financial incentives will more consistently carry their epinephrine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Behavioral: Text Message OnlyText Message Only |
| Intervention 2, Incentive | Experimental | Behavioral: Text message + Incentive 1Text message + Incentive |
| Cohort | No intervention | –For the cohort multiple randomized controlled trial (cmRCT), investigators will recruit 130 participants (the base cohort) ages 15-19. The base cohort allows investigators to measure normative food allergy self-management practices, while also serving as a control for experiments in Interventions 1 and 2. |
| Control | No intervention | –The baseline cohort serves as the control group in this cmRCT. Participants will not receive text message reminders (during Intervention 1) or incentives (during Intervention 2). However, they will participate in all data collection points, including text message check-ins to assess epinephrine-carrying. Participants in the base cohort will receive usual care. |
| Adolescent Allergy Advisors | No intervention | –We will pilot the text messages to be used in Interventions 1 and 2 through interviews and cognitive testing among 20 Adolescent Allergy Advisors, who will critique message content, framing, and language. These advisors will not be part of the cohort multiple randomized controlled trial. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Food allergy diagnosis by a physician and recorded in the medical chart
- Prior prescription of epinephrine auto-injector to treat anaphylaxis
- Access to a cell phone capable of sending and receiving text messages and photographs (our team will provide cell phones to participants willing to participate, but who do not own a cellphone)
- Fluent in English
- Between ages 15-19 at baseline
Key exclusion criteria (3 listed)
- Unable to obtain permission (consent) of a parent to participate in the study
- Will not or cannot give assent
- Currently participating in another clinical trial with related aims
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 |
|---|---|---|
| Text Message OnlyThe intervention group (n=25, randomly selected from the base cohort) will receive informational and socially supportive text messages during a 10-week intervention. Investigators will deploy the intervention using the Way to Health platform, which automates outgoing messages and feedback. Many of the messages will be sent to all Intervention 1 participants, to assure consistency of the intervention. A subset will be tailored to address participants' specific allergies. At 10 unannounced check-ins, we will send text messages asking participants in the intervention and control groups if they are carrying their epinephrine. | Behavioural | Intervention 1 |
| Text message + Incentive 1Among base cohort members not exposed to the text message only intervention (#1), we will randomly select a new intervention group (n=50) to receive text message reminders plus Incentive 1. At each of 10 unannounced check-ins, if unsuccessful in documenting epinephrine-carrying, participants will lose part of their incentive. The remainder of the Cohort (control) will receive text reminders. | Behavioural | Intervention 2, Incentive |
Primary outcome
Proportion of check-ins at which participant is carrying epinephrine auto-injector
Time frame: 10 randomly timed check-ins during the 10-week intervention period
Proportion of check-ins at which participant is carrying epinephrine auto-injector, measured using cell phone photographs
3 secondary outcomes
Characterize adolescents' normative food allergy management practices
Time frame: Year-long cohort study
Characterize adolescents' normative food allergy management practices
Time frame: Year-long cohort study
Develop a set of text message reminders to promote safer food allergy management among adolescents
Time frame: 2-year project period
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 25 Mar 2021.
- Derived from this study: PubMed 40068800Dupuis R, Spergel JM, Brown-Whitehorn TF, Troxel AB, Kenney EL, Block JP, Feuerstein-Simon R, Marti XL, Mollen CJ, Meisel ZF, Volpp KG, Gortmaker SL, Cannuscio CC. Incidence of food allergic reactions among adolescents engaged in food allergy management. Ann Allergy Asthma Immunol. 2025 Jun;134(6):719-723.e2. doi: 10.1016/j.anai.2025.02.023. Epub 2025 Mar 9.
- Individual participant dataSharing planned: No
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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
Jonathan Spergel, MD principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message Only and Text message + Incentive 1 in people with Food Allergy and Adherence, Medication, run by University of Pennsylvania at 2 sites 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 5 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 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proportion of check-ins at which participant is carrying epinephrine auto-injector (time frame: 10 randomly timed check-ins during the 10-week intervention period). 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 NCT03284372, 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 25 Mar 2021.