Behavioral Intervention for Celiac Disease
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.12345
Is the behavioral intervention for celiac disease safe for humans?
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.126910
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete baseline assessments before randomization
Treatment
Participants engage in a 6-week behavioral intervention with weekly telehealth sessions and SMS reminders
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Food for Thought
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's National Research Institute
Lead Sponsor
Children's Hospital Colorado
Collaborator