Behavioral Intervention for Celiac Disease

Recruiting at 1 trial location

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

96 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Food for Thought for celiac disease?

The effectiveness of the treatment 'Food for Thought' for celiac disease may be supported by research showing that computer-based interactive training programs (CBITPs) significantly increase knowledge and sustainability in managing a gluten-free diet, which is crucial for celiac patients. This suggests that similar behavioral interventions could enhance patients' ability to adhere to dietary restrictions and improve their quality of life. ^{1 2 3 4 5}

Is the behavioral intervention for celiac disease safe for humans?

The research articles reviewed do not provide specific safety data for the behavioral intervention for celiac disease, but they do discuss educational programs that improve knowledge about managing the condition. No safety concerns were reported in these studies. ^{2 6 7 8 9}

How does the treatment 'Food for Thought' differ from other treatments for celiac disease?

The 'Food for Thought' treatment is unique because it focuses on behavioral intervention rather than just dietary changes, addressing maladaptive food attitudes and behaviors that can impair quality of life in individuals with celiac disease. This approach is different from the standard gluten-free diet, which is the only known treatment for celiac disease, by aiming to improve patients' relationship with food and their overall well-being. ^{1 2 6 9 10}

What is the purpose of this trial?

Celiac disease (CD) is a chronic autoimmune condition whose only currently available treatment is a strict, burdensome gluten-free diet (GFD). The current proposal uses a theory-driven empirical approach for optimizing the GFD for teens and their parents by targeting knowledge, behavior, and coping skills through educational and cognitive-behavioral techniques. Integration with telehealth and SMS (short message service; "text") technology for delivering the intervention has the potential to reduce barriers to specialized treatment at both early and later stages of implementation. The proposed research will refine and test a behavioral intervention for teens with CD and their parents using an iterative stakeholder-centered design. It will consist of a small pilot randomized control trial (RCT) (n=96 dyads) that will examine the preliminary efficacy of the intervention and its impact on quality of life and GFD management by targeting self-efficacy, illness identity, and food-related activities. This work has the potential to make a lasting impact on the standards of care and available treatments to optimize CD management in youth and their families.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

(Outcome) Measure for (Intervention) Measures: A Guide to Choosing the Appropriate Noninvasive Clinical Outcome Measure for Intervention Studies in Celiac Disease. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Comparative analysis of conventional training and a computer-based interactive training program for celiac disease patients. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Psychosocial factors are more important than disease activity in determining gastrointestinal symptoms and health status in adults at a celiac disease referral center. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Development and Validation of a Specific Self-Efficacy Scale in Adherence to a Gluten-Free Diet. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Determinants and Trends of Adherence to a Gluten-Free Diet in Adult Celiac Patients on a Long-term Follow-up (2000-2020). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of In-Person, Gluten-Free Diet Education for Children With Celiac Disease. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Standardizing Randomized Controlled Trials in Celiac Disease: An International Multidisciplinary Appropriateness Study. [2023]

8. France pubmed.ncbi.nlm.nih.gov

Factors associated with non adherence to a gluten free diet in adult with celiac disease: A survey assessed by BIAGI score. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Maladaptive Food Attitudes and Behaviors in Individuals with Celiac Disease and Their Association with Quality of Life. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Quebecers with celiac disease: analysis of dietary problems. [2016]