Safer Food Allergy Management for Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safer Food Allergy Management for Adolescents

Conditions
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Food Allergy, Adherence, Medication

Intervention / Treatment
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* Behavioral: Text Message Only
* Behavioral: Text message + Incentive 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 1<br>Text Message Only | Behavioral: Text Message Only<br>* 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.<br>|
| Experimental: Intervention 2, Incentive<br>Text message + Incentive | Behavioral: Text message + Incentive 1<br>* 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.<br>|
| No Intervention: Cohort<br>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. | |
| No Intervention: Control<br>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. | |
| No Intervention: Adolescent Allergy Advisors<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 randomly timed check-ins during the 10-week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 2-year project period |