Celiac Disease in ChildrenNCT06038344
Influence of a Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Youth With Celiac Disease
A study testing Gluten-free food guide teaching in people with Celiac Disease in Children and Gluten Enteropathy, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Celiac Disease in Children, Gluten Enteropathy, Diet; Deficiency
- What is being tested?
- Gluten-free food guide teaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents, male and female, 5-18 years of age and their parents.
- Clinically diagnosed celiac disease
- Diagnosis within 3 months
Who cannot join
- Children, male and female, <5 years of age
- Celiac disease diagnosis >3 months
- Children/adolescents diagnosed with type 1 diabetes (T1D)
- Not clinically diagnosed with celiac disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Research Unit, University of Alberta
Edmonton, Alberta, T6G 0K2
About this study
Official title: Evaluation of the Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Newly Diagnosed Children and Youth With Celiac Disease in the Clinical Setting
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.
Read the detailed description
Background: The only treatment for celiac disease (CD) is the gluten-free (GF) diet which affects every 1 in 100 individuals. Non-adherence to the diet can lead to intestinal damage and nutrient malabsorption, which can negatively impact a critical period of growth and development in children. Despite adherence, the GF diet does not guarantee nutritional adequacy in children and can lead to obesity and chronic disease. A number of studies confirm that children and adults on GFDs often face several nutritional challenges, including low intakes of fibre, vitamin D, zinc, magnesium and high intakes of simple sugars and saturated fats associated with poor diet quality. Prepackaged GF foods are often high in simple sugars and saturated fat while being low in fibre, which are all known risk factors for the development of chronic disease in the adult population. While parents and newly diagnosed children with CD show significant improvements in knowledge about the GF diet after receiving standard-of-care education from healthcare practitioners at the time of diagnosis, some children with CD continue to experience significant challenges with reduced diet quality and nutritional inadequacy while on the GF diet, even after dietary education. Currently, there are no existing nutrition guidelines that are focused on the GFD. To address this issue, the investigation team recently developed a gluten-free food guide (GFFG). The GFFG consists of overall diet recommendations with a layout that mirrors the new Canada's Food Guide, associated teaching materials that address concepts related to nutrition literacy and knowledge as identified in the pre-guide stakeholder engagement with health care providers (RD, RN, MD) and families with children with CD (Mager et al., Br J Nutr 2022). Focus groups and online surveys were conducted for feasibility analysis with end-stakeholders (health professionals, parents/caregivers of children with CD, and adolescents with CD) to enable a comprehensive evaluation of the feasibility of the food guide in terms of content and layout (Mager et al., Br J Nutr 2022).
Study Objective: The study purpose is to compare the impact of dietary counselling using the GFFG versus standard of care (SOC) in children/adolescents and their parent/caregiver newly diagnosed with CD on participant care outcomes (diet quality, nutrition literacy, adherence to the GFD) over six months.
Hypothesis: The GFFG will increase diet quality and parental food literacy and improve adherence to the GFD in newly diagnosed children with CD and their parents over six months.
Sample size: Forty families (20/group) are proposed to enroll in this study. This sample size was based on a convenient sample.
Data Analysis: Data will be expressed as mean (± SD) or median (interquartile range) for parametric and non-parametric variables, respectively (tested by the Shapiro-Wilk test). T-tests (parametric) or Mann Whitney (non-parametric) tests to compare household characteristics (sociodemographic), adherence to the GFD, and DQ between SOC vs SOC+GFFG. Pearson and/or Spearman correlations will be conducted to assess the associations between child DQ and parental nutrition literacy, GFD adherence and household sociodemographics. Chi-square tests will be used to determine significant differences between categorical variables. P value < 0.05 adjusted for multiple comparisons will determine statistical significance.
- Being tested
- Gluten-free food guide teaching
- Keywords
- Gluten-Free Food Guide, Dietary Education, Dietary Quality, Celiac Disease
- Medical subject headings
- Celiac Disease, Malnutrition, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-free food guide teachingBehavioural
Teaching the gluten-free food guide will be done over Zoom within 1-2 weeks of the dietitian's standard of care teaching (group Zoom session). This teaching will take 30-45 minutes and will be conducted by a trained researcher. The investigators will use the gluten-free food guide as teaching materials with a focus on the GF plate model, the rationale for the GF plate model, nutritional consideration of gluten-free diet and content related to the additional 24 teaching materials (e.g. folate, fibre, eating out, school lunches etc.) contained within the guide. Individualized dietary suggestions based on participants' food records will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care + Gluten-free food guide teaching | Experimental | 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. Receives: Behavioral: Gluten-free food guide teaching |
| Standard of Care | No 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary quality
Child/adolescent dietary intake will be collected using three-day food intake records (2 weekdays and 1 weekend day), and diet quality will be analyzed using Healthy Eating Index-Canada (score out of 100) at study entry. The maximum score for Healthy Eating Index-Canada is 100 (indicating high diet quality) and the lowest score of 0 reflects poor diet quality. Scores of 80 and over are representative of good-excellent diet quality, Scores of 60-80 reflect needs improvement of diet quality and less than 60 indicative of poor diet quality.
Measured: Baseline
Dietary quality
Child/adolescent dietary intake will be collected using three-day food intake records (2 weekdays and 1 weekend day), and diet quality will be analyzed using Healthy Eating Index-Canada (score out of 100) at 6 months. The maximum score for Healthy Eating Index-Canada is 100 (indicating high diet quality) and the lowest score of 0 reflects poor diet quality. Scores of 80 and over are representative of good-excellent diet quality, Scores of 60-80 reflect needs improvement of diet quality and less than 60 indicative of poor diet quality.
Measured: 6 months
Secondary outcomes (6)
Self-reported adherence to the gluten-free diet.
Assessment of child/adolescent adherence to the GFD will be evaluated by a self-reported questionnaire (Kindl Test ®) at baseline. This is a questionnaire that consists of 10 questions related to dietary adherence and quality of life. Max score is 10. Minimum score is 0. Higher scores indicative of lower adherence and quality of life.
Measured: Baseline
Self-reported adherence to the gluten-free diet
Assessment of child/adolescent adherence to the GFD will be evaluated by a self-reported questionnaire (Kindl Test ®) at 6 months. This is a questionnaire that consists of 10 questions related to dietary adherence and quality of life. Max score is 10. Minimum score is 0. Higher scores indicative of lower adherence and quality of life.
Measured: 6 months
Gluten intake
Assessment of changes in child/adolescent gluten intake will be calculated from a 3-day food record using the gluten-calculation equation ((grain weight (in gms) *20)/1000) at study entry. Gluten Values less than 10 mg/d in the diet considered low gluten intake associated with adherence to the gluten free diet.
Measured: Baseline
Gluten intake
Assessment of changes in child/adolescent gluten intake will be calculated from a 3-day food record using the gluten-calculation equation ((grain weight (in gms) *20)/1000)at 6 months. Gluten Values less than 10 mg/d in the diet considered low gluten intake associated with adherence to the gluten free diet.
Measured: 6 months
Parental Nutrition Literacy
Parental nutrition literacy will be measured using the validated Nutrition Literacy Assessment Tool for Adults at study entry. The validated tool consists of 30 questions and scoring can range between 0-30. Excellent scores > 24.
Measured: Baseline
Parental Nutrition Literacy
Parental nutrition literacy will be measured using the validated Nutrition Literacy Assessment Tool for Adults at six months. The validated tool consists of 30 questions and scoring can range between 0-30. Excellent scores > 24.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start22 Jun 2021
- Primary completion31 Jan 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Diana R Mager, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038344
- Sponsor's protocol ID
- Pro00111071
- Status last verified
- May 2026
- First submitted
- 29 Aug 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be presented in aggregate form in peer review publications and/or conference proceedings.
Publications
Mager DR, Cyrkot S, Lirette C, Brill H, Dowhaniuk J, Mileski H, Basualdo-Hammond C, Nasser R, Assor E, Marcon M, Turner JM. Nutritional considerations of a paediatric gluten-free food guide for coeliac disease. Br J Nutr. 2022 Feb 14;127(3):421-430. doi: 10.1017/S0007114521000994. Epub 2021 Mar 22.
PubMed 33745459Mager DR, Cyrkot S, Lirette C, Brill H, Dowhaniuk J, Mileski H, Basualdo-Hammond C, Nasser R, Assor E, Marcon M, Turner JM. Evaluation of a paediatric gluten-free food guide by children and youth with coeliac disease, their parents and health care professionals. Br J Nutr. 2022 Jun 28;127(12):1784-1795. doi: 10.1017/S0007114521002774. Epub 2021 Jul 23.
PubMed 34294170
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Gluten Free Food Guide on Diet Quality and Adherence to the GFD in Newly Diagnosed Children and Youth With Celiac Disease in the Clinical Setting
- ClinicalTrials.gov ID
- NCT06038344
- Acronym / sponsor ID
- Pro00111071
- Keywords
- Gluten-Free Food Guide, Dietary Education, Dietary Quality, Celiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: The only treatment for celiac disease (CD) is the gluten-free (GF) diet which affects every 1 in 100 individuals. Non-adherence to the diet can lead to intestinal damage and nutrient malabsorption, which can negatively impact a critical period of growth and development in children. Despite adherence, the GF diet does not guarantee nutritional adequacy in children and can lead to obesity and chronic disease. A number of studies confirm that children and adults on GFDs often face several nutritional challenges, including low intakes of fibre, vitamin D, zinc, magnesium and high intakes of simple sugars and saturated fats associated with poor diet quality. Prepackaged GF foods are often high in simple sugars and saturated fat while being low in fibre, which are all known risk factors for the development of chronic disease in the adult population. While parents and newly diagnosed children with CD show significant improvements in knowledge about the GF diet after receiving standard-of-care education from healthcare practitioners at the time of diagnosis, some children with CD continue to experience significant challenges with reduced diet quality and nutritional inadequacy while on the GF diet, even after dietary education. Currently, there are no existing nutrition guidelines that are focused on the GFD. To address this issue, the investigation team recently developed a gluten-free food guide (GFFG). The GFFG consists of overall diet recommendations with a layout that mirrors the new Canada's Food Guide, associated teaching materials that address concepts related to nutrition literacy and knowledge as identified in the pre-guide stakeholder engagement with health care providers (RD, RN, MD) and families with children with CD (Mager et al., Br J Nutr 2022). Focus groups and online surveys were conducted for feasibility analysis with end-stakeholders (health professionals, parents/caregivers of children with CD, and adolescents with CD) to enable a comprehensive evaluation of the feasibility of the food guide in terms of content and layout (Mager et al., Br J Nutr 2022).
Study Objective: The study purpose is to compare the impact of dietary counselling using the GFFG versus standard of care (SOC) in children/adolescents and their parent/caregiver newly diagnosed with CD on participant care outcomes (diet quality, nutrition literacy, adherence to the GFD) over six months.
Hypothesis: The GFFG will increase diet quality and parental food literacy and improve adherence to the GFD in newly diagnosed children with CD and their parents over six months.
Sample size: Forty families (20/group) are proposed to enroll in this study. This sample size was based on a convenient sample.
Data Analysis: Data will be expressed as mean (± SD) or median (interquartile range) for parametric and non-parametric variables, respectively (tested by the Shapiro-Wilk test). T-tests (parametric) or Mann Whitney (non-parametric) tests to compare household characteristics (sociodemographic), adherence to the GFD, and DQ between SOC vs SOC+GFFG. Pearson and/or Spearman correlations will be conducted to assess the associations between child DQ and parental nutrition literacy, GFD adherence and household sociodemographics. Chi-square tests will be used to determine significant differences between categorical variables. P value < 0.05 adjusted for multiple comparisons will determine statistical significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + Gluten-free food guide teaching | Experimental | Behavioral: Gluten-free food guide teaching45-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. |
| Standard of Care | No 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). |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children and adolescents, male and female, 5-18 years of age and their parents.
- Clinically diagnosed celiac disease
- Diagnosis within 3 months
Key exclusion criteria (4 listed)
- Children, male and female, <5 years of age
- Celiac disease diagnosis >3 months
- Children/adolescents diagnosed with type 1 diabetes (T1D)
- Not clinically diagnosed with celiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten-free food guide teachingTeaching the gluten-free food guide will be done over Zoom within 1-2 weeks of the dietitian's standard of care teaching (group Zoom session). This teaching will take 30-45 minutes and will be conducted by a trained researcher. The investigators will use the gluten-free food guide as teaching materials with a focus on the GF plate model, the rationale for the GF plate model, nutritional consideration of gluten-free diet and content related to the additional 24 teaching materials (e.g. folate, fibre, eating out, school lunches etc.) contained within the guide. Individualized dietary suggestions based on participants' food records will also be provided. | Behavioural | Standard of Care + Gluten-free food guide teaching |
Primary outcome
Dietary quality
Time frame: Baseline
Child/adolescent dietary intake will be collected using three-day food intake records (2 weekdays and 1 weekend day), and diet quality will be analyzed using Healthy Eating Index-Canada (score out of 100) at study entry. The maximum score for Healthy Eating Index-Canada is 100 (indicating high diet quality) and the lowest score of 0 reflects poor diet quality. Scores of 80 and over are representative of good-excellent diet quality, Scores of 60-80 reflect needs improvement of diet quality and less than 60 indicative of poor diet quality.
Dietary quality
Time frame: 6 months
Child/adolescent dietary intake will be collected using three-day food intake records (2 weekdays and 1 weekend day), and diet quality will be analyzed using Healthy Eating Index-Canada (score out of 100) at 6 months. The maximum score for Healthy Eating Index-Canada is 100 (indicating high diet quality) and the lowest score of 0 reflects poor diet quality. Scores of 80 and over are representative of good-excellent diet quality, Scores of 60-80 reflect needs improvement of diet quality and less than 60 indicative of poor diet quality.
6 secondary outcomes
Self-reported adherence to the gluten-free diet.
Time frame: Baseline
Self-reported adherence to the gluten-free diet
Time frame: 6 months
Gluten intake
Time frame: Baseline
Gluten intake
Time frame: 6 months
Parental Nutrition Literacy
Time frame: Baseline
Parental Nutrition Literacy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 33745459Mager DR, Cyrkot S, Lirette C, Brill H, Dowhaniuk J, Mileski H, Basualdo-Hammond C, Nasser R, Assor E, Marcon M, Turner JM. Nutritional considerations of a paediatric gluten-free food guide for coeliac disease. Br J Nutr. 2022 Feb 14;127(3):421-430. doi: 10.1017/S0007114521000994. Epub 2021 Mar 22.
- Background: PubMed 34294170Mager DR, Cyrkot S, Lirette C, Brill H, Dowhaniuk J, Mileski H, Basualdo-Hammond C, Nasser R, Assor E, Marcon M, Turner JM. Evaluation of a paediatric gluten-free food guide by children and youth with coeliac disease, their parents and health care professionals. Br J Nutr. 2022 Jun 28;127(12):1784-1795. doi: 10.1017/S0007114521002774. Epub 2021 Jul 23.
- Individual participant dataSharing planned: No. Data will only be presented in aggregate form in peer review publications and/or conference proceedings.
Related trials for Celiac Disease in Children
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
Active, not recruiting
Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
Enrolling by invitation
Immune Responses to Gluten
Celiac Disease, Malabsorption Syndromes
RecruitingObservational study
Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
Celiac Disease in Children, Celiac Disease in Adolescents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana R Mager principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-free food guide teaching in people with Celiac Disease in Children and Gluten Enteropathy, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary quality (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038344, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.