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Behavioral Intervention

Gluten-Free Diet Guidance for Celiac Disease

N/A

Waitlist Available

Led By Diana R Mager

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Clinically diagnosed celiac disease

Be younger than 65 years old

Must not have

Children/adolescents diagnosed with type 1 diabetes (T1D)

Not clinically diagnosed with celiac disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate if a new GF-food guide helps children newly diagnosed with celiac disease improve their diet quality, nutrition literacy and adherence to a gluten-free diet.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since this trial involves dietary guidance rather than medication, there are no direct side effects like you'd expect from drugs. However, adjusting to new diets may cause temporary digestive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with celiac disease by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have not been diagnosed with celiac disease.

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My child is under 5 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Dietary quality

Secondary study objectives

Gluten intake

Parental Nutrition Literacy

Self-reported adherence to the gluten-free diet

+1 more

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: 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).

0 / 4Eligibility criteria met