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Completed

NCT Number: NCT03284372

Safer Food Allergy Management for Adolescents

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.

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Key information

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text Message Only

Behavioral

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 1

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Characterize adolescents' normative food allergy management practices

    Time frame: Year-long cohort study

    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.

  2. Characterize adolescents' normative food allergy management practices

    Time frame: Year-long cohort study

    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.

  3. Develop a set of text message reminders to promote safer food allergy management among adolescents

    Time frame: 2-year project period

    Develop a set of text message reminders to promote safer food allergy management among adolescents by cognitively testing text message content

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 15, 2017
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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