Safer Food Allergy Management for Adolescents

Not Applicable

Completed

• Conditions: Food Allergy; Adherence, Medication
• Interventions: Behavioral: Text Message Only; Behavioral: Text message + Incentive 1

• Registration Number: NCT03284372
• Lead Sponsor: University of Pennsylvania

Brief 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. 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 Timeline

• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-15
• Study Start: 2018-01-18
• Primary Completion: 2020-01-18
• Study Completion: 2020-07-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention 1	Text Message Only	Text Message Only
Intervention 2, Incentive	Text message + Incentive 1	Text message + Incentive

Primary Outcome Measures

Name	Time	Method
Proportion of check-ins at which participant is carrying epinephrine auto-injector	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 Outcome Measures

Name	Time	Method
Characterize adolescents' normative food allergy management practices	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.
Develop a set of text message reminders to promote safer food allergy management among adolescents	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

Trial Locations

Locations (2)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States