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Behavioral Intervention for Celiac Disease

N/A
Waitlist Available
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Teens 12-16 years at the time of enrollment
Teens with a physician-confirmed CD diagnosis and one parent or guardian
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately post-intervention, 3 month follow-up
Awards & highlights

Study Summary

This trial is testing a new way to help people with celiac disease who have to follow a strict gluten-free diet. The trial is testing a new intervention delivered through text messages and telehealth to help teens with celiac disease and their parents. The goal is to improve quality of life and management of the gluten-free diet by targeting self-efficacy, illness identity, and food-related activities.

Who is the study for?
This trial is for teens aged 12-16 with a confirmed diagnosis of Celiac Disease, along with one parent or guardian. They must be able to use video conferencing and SMS messaging, speak English fluently, and receive care from the Children's National Hospital's celiac clinic. Teens with developmental disabilities or major neuropsychological conditions that could affect participation are not eligible.Check my eligibility
What is being tested?
The GROW Project aims to help teens with Celiac Disease and their parents manage a gluten-free diet by improving knowledge, behavior, and coping skills through educational and cognitive-behavioral techniques delivered via telehealth and text messages. The study will test this intervention in a small pilot randomized control trial to see if it improves quality of life and diet management.See study design
What are the potential side effects?
Since this is a behavioral intervention focusing on education and coping strategies rather than medication or medical procedures, there are no direct physical side effects expected from participating in the GROW Project.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 16 years old.
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I am a teenager diagnosed with Crohn's disease and have a parent or guardian.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately post-intervention, 3 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately post-intervention, 3 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gluten Immunogenic Peptides as measured by GlutenDetect
Gluten-Free Diet Experiences as assessed by qualitative interview about perceived QOL and GFD management experiences
Gluten-Free Diet Management (expert) as measured by Expert GFD Adherence Rating (SDE)
+5 more
Secondary outcome measures
Illness Identity as measured by the Illness Identity Questionnaire
Self-Efficacy as measured by the Celiac-SE

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: GROW+ ProjectExperimental Treatment1 Intervention
("GROW+" Group): Will include the GROW Project with enhanced behavioral strategies and materials identified from phase 2 data (e.g., group discussion about GIP testing, text-based check-ins, etc.) In addition, teens in GROW+ will be encouraged to complete a minimum of 2 GlutenDetect tests per week (12 total) and report results in REDCap (Research Electronic Data Capture, a secure, web-based survey application) throughout the intervention.
Group II: GROW ProjectExperimental Treatment1 Intervention
("GROW" Group): Live interactive telehealth-based group meetings will be held for 60 minutes per week over six weeks using Zoom for Telehealth, a HIPAA-compliant platform provided by the PI's institution. A teen group (n=8 per cohort) and a parent group (n=8 per cohort) will be run concurrently but separately, with coordinating topics. Each group meeting will introduce and facilitate discussion of information and CBT-oriented topics for coping and management of CD. Participants will be encouraged to use their audio and video to engage with the interventionist and each other. Between sessions, resources sent through text-based SMS messages using Twilio HIPAA-compliant software 3x/week as reminders of skills and goals for the week.
Group III: Care-As-UsualActive Control1 Intervention
Participants assigned to the control group (n=32 dyads) will receive care as usual, which consists of appointments in the Celiac Disease Clinic (at diagnosis, 3 months post-diagnosis, 6 months post-diagnosis, and annually after diagnosis thereafter). These appointments consist of a gastrointestinal physician or nurse practitioner, dietitian, GFD educator, and psychologist for 40-minute consultations each.

Find a Location

Who is running the clinical trial?

Children's Hospital ColoradoOTHER
114 Previous Clinical Trials
5,127,439 Total Patients Enrolled
1 Trials studying Celiac Disease
400 Patients Enrolled for Celiac Disease
Children's National Research InstituteLead Sponsor
209 Previous Clinical Trials
207,649 Total Patients Enrolled

Media Library

Food for Thought Clinical Trial Eligibility Overview. Trial Name: NCT05204446 — N/A
Celiac Disease Research Study Groups: GROW Project, GROW+ Project, Care-As-Usual
Celiac Disease Clinical Trial 2023: Food for Thought Highlights & Side Effects. Trial Name: NCT05204446 — N/A
Food for Thought 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204446 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are older individuals being integrated into this research cohort?

"The age window for this trial's participants is between 12-16 years old."

Answered by AI

Am I able to register for this clinical experiment?

"Entry into this trial necessitates that patients have celiac disease and are between the ages of 12-16. Approximately 60 participants can be enrolled in the experiment."

Answered by AI

Are there any available slots in this research project for volunteers?

"According to clinicaltrials.gov, the study that was posted on June 7th 2022 is not currently welcoming any new patients into its ranks. However, 30 other trials are actively recruiting at this moment in time."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Children's National Hospital
~56 spots leftby Oct 2026