Gluten-Free Diet Guidance for Celiac Disease

Recruiting in Palo Alto (17 mi)

Overseen byDiana R Mager

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Trial Summary

What is the purpose of this trial?

Celiac disease (CD) is an autoimmune gastrointestinal disease that is caused by intolerance to gluten in the diet. The mainstay of treatment is a gluten-free diet (GFD). Children with CD on the GFD often have low micronutrient intakes (e.g. folate, iron) and high intakes of sugar and fat. Current Canadian nutrition guideline does not address these nutritional limitations. The investigation team developed a novel GF-food guide (GFFG). This randomized clinical trial aims to evaluate the impact of GFFG on diet quality and adherence to the GFD in newly diagnosed children and youth with celiac disease in the clinical setting. The investigators will compare dietary counselling using the GFFG versus the standard of care in children newly diagnosed with CD and their parents to see if participant care outcomes (diet quality, nutrition literacy, adherence to the GFD) improved over six months.

Research Team

Diana R Mager

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for children and adolescents aged 5-18 with a recent diagnosis of celiac disease within the last 3 months. Their parents are also involved. It's not suitable for those under 5, diagnosed over 3 months ago, with type 1 diabetes, or without a clinical diagnosis of celiac disease.

Inclusion Criteria

You were diagnosed with the condition within the last 3 months.

I am between 5 and 18 years old.

I have been diagnosed with celiac disease by a doctor.

Exclusion Criteria

I was diagnosed with celiac disease more than 3 months ago.

I am a child or teenager diagnosed with type 1 diabetes.

I have not been diagnosed with celiac disease.

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Treatment Details

Interventions

Gluten-free food guide teaching (Behavioral Intervention)

Trial OverviewThe study tests if teaching about a Gluten-Free Food Guide can improve diet quality and adherence to a gluten-free diet in youth with celiac disease compared to standard dietary counseling.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care + Gluten-free food guide teachingExperimental Treatment1 Intervention

45-minute dietary counselling session using the novel gluten-free food guide conducted by a researcher over Zoom. This occurs after standard of care dietary education by an RD. The gluten free teaching session in the study protocol focuses on the GF plate model, the rationale for the GF plate model, and addressing the individual participants dietary needs based on a dietary intake assessment by a trained investigator using specific educational materials that are present in the guide.

Group II: Standard of CareActive Control1 Intervention

45-minute group session on the gluten-free diet conducted by registered dietitians over Zoom. The registered dietitian's dietary education included a virtual group class focusing on gluten literacy, meal planning, food label reading and dietary intake based on Canada's Food Guide to Healthy Eating (2019).