Gluten-Free Diet Education for Celiac Disease

(GF-NOURISH Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Food allergies, Dietary conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is a gluten-free diet safe for humans?

A gluten-free diet is considered safe for people with celiac disease and other gluten-related disorders, but it is important to ensure the diet is balanced and free from contamination. Proper education and adherence to the diet are crucial for safety and effectiveness. ^{1 2 3 4 5}

How does Gluten-Free Diet Education differ from other treatments for celiac disease?

Gluten-Free Diet Education is unique because it focuses on teaching patients how to manage celiac disease through dietary changes, empowering them to make informed food choices, unlike other treatments that might involve medication or supplements. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Gluten-Free Diet Education for Celiac Disease?

Research shows that educational programs, including group-based and computer-based interactive training, significantly improve knowledge and adherence to a gluten-free diet in patients with celiac disease. Additionally, active patient education programs have been shown to reduce gastrointestinal symptoms and improve quality of life for those following a gluten-free diet. ^{11 12 13 14 15}

Are You a Good Fit for This Trial?

This trial is for individuals with Celiac Disease who may also be dealing with malnutrition or other nutrition disorders. The key eligibility criteria are not fully listed, but participants would typically need to have a confirmed diagnosis of Celiac Disease and possibly face nutritional challenges.

Exclusion Criteria

Allergic to less than 3 of the top 8 food allergens

Co-morbid conditions treated with dietary modifications or that influence nail arsenic values

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutritional education focused on minimizing ultra-processed gluten-free foods or conventional GFD education

6 months

Regular visits for educational sessions

Follow-up

Participants are monitored for changes in body composition, diet quality, and arsenic exposure after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gluten-Free Diet Education

Trial Overview The GF-NOURISH study is testing the effectiveness of a nutritional education program that emphasizes natural gluten-free foods while reducing ultra-processed gluten-free options. It aims to show how this approach can lead to better health outcomes for those with Celiac Disease.

How Is the Trial Designed?

Group I: GFFG Experimental Treatment 1 Intervention

Our Canadian collaborators have created Gluten Free-Food Guide (GFFG), a validated nutritional educational intervention, which targets increasing consumption of natural gluten free foods and limiting UPFs. However, this intervention has not yet been applied to a pediatric cohort in the United States. Preliminary data demonstrate enrollment feasibility and generalizability of the intervention. The GFFG arm will have increased focus on plant proteins, minimally processed food intake and fruit/vegetable intake with emphasis on naturally gluten-free foods. The GFFG class will highlight that not all gluten-free foods have the same nutritional and health benefits.

Group II: Conventional GFD Nutrition Education Active Control 1 Intervention

Diet counselling in both the conventional GFD nutrition education and the GFFG intervention arm will include concepts related to nutrition literacy (food label reading, gluten identification, nutritional adequacy). The control group will be provided with the GFFG at the end of the study.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

Children with celiac disease who were lost to follow-up (LTFU) showed significantly poorer adherence to a gluten-free diet (GFD), with an average Biagi score of 2.0 compared to 3.0 in those who regularly followed up, indicating a need for better monitoring and support.

LTFU patients had a higher prevalence of positive celiac serology tests (50% vs. 25% in controls), suggesting that non-adherence to the GFD is linked to worse health outcomes, and factors such as older age at diagnosis and lack of membership in celiac associations contribute to this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric celiac disease patients who are lost to follow-up have a poorly controlled disease. Barnea, L., Mozer-Glassberg, Y., Hojsak, I., et al.[2015]

TEACH Kitchen, a student-led initiative at the Medical College of Georgia, aims to improve nutrition education and healthy cooking skills among patients with chronic diseases, addressing a significant gap in healthcare.

The program has enrolled 14 patients and 6 children, focusing on modules related to obesity, hypertension, hyperlipidemia, and diabetes, with the goal of measuring improvements in knowledge and clinical indicators like body mass index and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TEACH Kitchen: A Chronological Review of Accomplishments. Chae, JH., Ansa, BE., Smith, SA.[2020]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pediatric celiac disease patients who are lost to follow-up have a poorly controlled disease. [2015]

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

A Cooking-Based Intervention Promotes Gluten-Free Diet Adherence and Quality of Life for Adults with Celiac Disease. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The Effect of Group-Based Education on Knowledge and Adherence to a Gluten-Free Diet in Patients with Celiac Disease: Randomized Controlled Clinical Trial. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Impact of an active patient education program on gastrointestinal symptoms in women with celiac disease following a gluten-free diet: a randomized controlled trial. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Gluten-Free Diet Indications, Safety, Quality, Labels, and Challenges. [2022]

7. India pubmed.ncbi.nlm.nih.gov

All that a physician should know about gluten-free diet. [2019]

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

Safety of Adding Oats to a Gluten-Free Diet for Patients With Celiac Disease: Systematic Review and Meta-analysis of Clinical and Observational Studies. [2018]

9. Italy pubmed.ncbi.nlm.nih.gov

Gluten-free diet in non-celiac patients: beliefs, truths, advantages and disadvantages. [2020]

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

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

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

The diet of diabetic patients in Spain in 2008-2010: accordance with the main dietary recommendations--a cross-sectional study. [2022]

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

TEACH Kitchen: A Chronological Review of Accomplishments. [2020]

13. France pubmed.ncbi.nlm.nih.gov

[The nutritional education of patients with diabetes]. [2017]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Development and Evaluation of an Internet-Based Diabetes Nutrition Education Resource. [2020]

15. England pubmed.ncbi.nlm.nih.gov

Use of a web-based educational intervention to improve knowledge of healthy diet and lifestyle in women with Gestational Diabetes Mellitus compared to standard clinic-based education. [2019]