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

N/A

Waitlist Available

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to show the benefits of a nutrition education program that focuses on natural gluten-free foods and limits processed gluten-free foods. The study will assess whether this education program can improve health outcomes."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves dietary changes rather than medication, side effects might include digestive adjustments as the body adapts to new eating habits. Specific side effects are not listed but could vary based on individual reactions to diet changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass

Secondary study objectives

To compare the effect of GFFG versus conventional GFD on arsenic exposure

To compare the effect of GFFG vs conventional GFD class on diet quality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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