Safer Food Allergy Management for Adolescents

Food Allergy Clinical Trial

Official title:

Safer Food Allergy Management for Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284372
• Other study ID #: 827073
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 31, 2020
• Est. primary completion date: January 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Behavioral:
• Text Message Only
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
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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