Gluten-Free Diet Education for Celiac Disease
(GF-NOURISH Trial)

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Children's Hospital

No Placebo Group

Trial Summary

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

Eligibility Criteria

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.

Inclusion Criteria

I am between 2 and 18 years old and was recently diagnosed with celiac disease.

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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: GFFGExperimental Treatment1 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 EducationActive Control1 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.