Behavioral Intervention for Celiac Disease

Enrolling by invitation at 2 trial locations

Overseen By Michelle Harlan

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Disqualifiers: Developmental disability, Neuropsychological condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help teens with celiac disease manage their condition by refining their gluten-free diet and improving coping skills. It tests a behavioral program called "Food for Thought," which includes educational sessions via telehealth and supportive text messages to enhance knowledge and self-management. The study compares different group programs, offering varied support levels, including one with additional strategies like group discussions and self-testing for gluten exposure. Teens aged 12-16 with a confirmed celiac disease diagnosis and regular access to video conferencing and texting tools might be a good fit. As an unphased trial, this study provides a unique opportunity for teens to gain valuable skills and support in managing celiac disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a behavioral intervention for managing a gluten-free diet in teens with celiac disease.

What prior data suggests that this behavioral intervention is safe for teens with celiac disease?

Research has shown that the "GROW" Project is a family-focused online program designed to help teens with celiac disease (CD) and their parents manage the condition. The program aims to improve quality of life and assist with following a gluten-free diet (GFD) using practical techniques. As a behavior-focused program, it does not involve any new drugs, eliminating concerns about drug-related side effects.

The "GROW+" Project builds on the original GROW program by adding more strategies and materials, including group discussions and regular text check-ins. It also encourages teens to use GlutenDetect tests twice a week to monitor gluten intake. Like the GROW Project, this program focuses on behavior, so drug safety is not a concern.

Both programs use telehealth, providing support online. This method is safe and has been well-received by participants in previous studies. The goal is to help families manage CD more effectively without the need for new medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative behavioral interventions for managing celiac disease, a condition traditionally addressed through strict adherence to a gluten-free diet. The GROW Project stands out by offering live, interactive telehealth meetings that teach coping and management skills using cognitive-behavioral therapy (CBT) techniques. The GROW+ Project goes a step further by incorporating new strategies like group discussions about gluten immunogenic peptide (GIP) testing and encouraging teens to use GlutenDetect tests to monitor their gluten exposure. These approaches aim to empower both teens and parents with practical tools and support, potentially enhancing their quality of life beyond the current standard care.

What evidence suggests that this trial's behavioral interventions could be effective for managing celiac disease?

Research has shown that the GROW Project, a treatment arm in this trial, is the first online program designed for families, focusing on teenagers with celiac disease and their parents. Studies have found that this program can improve quality of life and help manage a gluten-free diet (GFD) more effectively by teaching strategies for better self-management and coping skills. Another treatment arm, the GROW+ Project, includes everything from the GROW Project, plus additional tools like testing for gluten in food. This approach aims to enhance both knowledge and practical skills, helping families manage celiac disease more successfully. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are currently being treated for celiac disease at the Children's National Hospital.

I am between 12 and 16 years old.

I am a teenager diagnosed with Crohn's disease and have a parent or guardian.

Exclusion Criteria

The teenager has a disability or condition that would make it hard for them to communicate and engage with others in the study.

My Crohn's disease diagnosis is uncertain or has been changed.

Another member of their household is already enrolled in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments before randomization

1 week

Treatment

Participants engage in a 6-week behavioral intervention with weekly telehealth sessions and SMS reminders

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Food for Thought

Trial Overview 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.

How Is the Trial Designed?

Group I: GROW+ Project Experimental Treatment 1 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 Project Experimental Treatment 1 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-Usual Active Control 1 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.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

Published Research Related to This Trial

A study involving 18 gastroenterologists and pathologists established standardized recommendations for designing randomized controlled trials (RCTs) for celiac disease, focusing on trial configurations, inclusion criteria, and outcome measures.

For trials assessing the prevention of relapse after gluten exposure, participants should have been on a gluten-free diet for at least 12 months, and efficacy should be evaluated through histological changes and patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing Randomized Controlled Trials in Celiac Disease: An International Multidisciplinary Appropriateness Study. Lebwohl, B., Ma, C., Lagana, SM., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10918335

Project Details - NIH RePORTER The primary objective of this research proposal is to refine and test the first behavioral intervention for teens with celiac disease and their parents.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05204446

NCT05204446 | Behavioral Intervention for Celiac Disease The only treatment for CD is a strict Gluten-Free Diet (GFD), which is complex, expensive, tiring, and anxiety-provoking. CD is also associated with impaired ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40304638/

The Gluten-Free Resilience and Overall Wellness (GROW ... The first family-centered, online behavioral intervention to improve QOL and GFD self-management in adolescents with CD and their parents.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0010482524015907

Effectiveness of a nutrition education programme for ... GLUTLEARN has been found to be effective in improving the knowledge of people with CD and their supporters and improving attitudes among individuals.

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/02601060251330938

The Gluten-Free Resilience and Overall Wellness (GROW) ... The GROW Project addresses a critical need for interventions that strengthen behavioral self-management strategies in adolescents with CD and their families.

6. researchgate.net researchgate.net/publication/391330837_Behavioral_telehealth_intervention_development_for_adolescents_with_celiac_disease_and_their_caregivers_The_Gluten-Free_Resilience_and_Overall_Wellness_GROW_project

Behavioral telehealth intervention development for ... Aims Develop and refine the Gluten-Free Resilience and Overall Wellness (GROW) Project, the first family-centered, online behavioral ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8308338/

Food Safety and Cross-Contamination of Gluten-Free ... Overall, gluten exceeding 20 mg/kg was detected in 371 samples (12%), with breakfast cereals/bars being the most contaminated group (Table 1).

8. celiac.org celiac.org/wp-content/uploads/2016/02/FINAL_Celiac-Disease-and-Gluten-Related-Conditions-Psychological-Health-Training-Manual.pdf

and Gluten-Related Conditions Below is a list of food additives that are safe for a gluten-free diet: Acacia Gum. Adipic Acid. Algin. Annatto. Aspartame. Baking Yeast. Benzoic Acid. Beta ...

9. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1321360/full

Experiences and perceptions of people with celiac disease ... We conclude that people with food intolerances of different origins and special dietary needs are at risk when eating out; our results indicate ...

10. academic.oup.com academic.oup.com/nutritionreviews/advance-article/doi/10.1093/nutrit/nuaf069/8152198?searchresult=1

Gluten-Free Diet in the Context of Food and Nutrition Security ... A gluten-free diet (GFD) is the only safe treatment for people with gluten-related disorders (GRDs). However, adherence to a GFD is ...