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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with celiac disease by a doctor.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dietary quality

Secondary outcome measures

Gluten intake

Parental Nutrition Literacy

Self-reported adherence to the gluten-free diet

+1 more

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

886 Previous Clinical Trials

384,738 Total Patients Enrolled

Alberta Health servicesOTHER

157 Previous Clinical Trials

649,504 Total Patients Enrolled

Diana R MagerPrincipal InvestigatorUniversity of Alberta

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the requirements for participating in this medical experiment?

"To meet the acceptance criteria for this medical trial, potential participants must be aged 5 to 18 and diagnosed with celiac disease. This research is seeking 40 total patients."

Answered by AI

Does this medical study permit elderly individuals over 80 years of age to participate?

"In compliance with the requirements of this clinical study, participants must fall within a specified range and be at least 5 years old but no older than 18."

Answered by AI

Are there any current openings for participation in this research study?

"This research study is not currently recruiting patients, despite being initially posted on June 22nd 2021 and most recently edited on September 12th 2023. However, 211 other clinical trials are actively enrolling participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Influence of a Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Youth With Celiac Disease

2021. "Influence of a Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Youth With Celiac Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038344.

All > Celiac Disease