Safer Food Allergy Management for Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03284372|
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Food Allergy Adherence, Medication||Behavioral: Text Message Only Behavioral: Text message + Incentive 1 Behavioral: Text message + Incentive 2||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Safer Food Allergy Management for Adolescents|
|Actual Study Start Date :||January 8, 2018|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: Intervention 1
Text Message Only
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.
Experimental: Intervention 2, Incentive 1
Text message + Incentive 1
Behavioral: 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=25) 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.
Experimental: Intervention 2, Incentive 2
Text message + Incentive 2
Behavioral: Text message + Incentive 2
Among base cohort members not exposed to the text message only intervention (#1), we will randomly select a new intervention group (n=25) to receive text message reminders plus Incentive 2 (at each of 10 check-in, successful participants will have a 2/5 chance of winning a small prize or a 2/25 chance of winning a bigger prize). The remainder of the Cohort (control) will receive text reminders.
No Intervention: Cohort
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
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
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.
- 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
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284372
|Contact: Carolyn C Cannuscio, ScDemail@example.com|
|Contact: Xochitl Luna Martifirstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Jonathan Spergel, MD|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Carolyn C Cannuscio, ScD 215-746-4175 email@example.com|
|Contact: Roxanne Dupuis, MSPH 215.573.6917 firstname.lastname@example.org|
|Principal Investigator:||Carolyn C Cannuscio, ScD||University of Pennsylvania|
|Principal Investigator:||Jonathan Spergel, MD||Children's Hospital of Philadelphia|