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

NCT ID: NCT06038344

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-22
• Study Completion Date: 2024-12-31

Brief 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. 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.

Conditions

Celiac Disease in Children; Gluten Enteropathy; Diet; Deficiency; Adherence, Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care + Gluten-free food guide teaching

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 Type: EXPERIMENTAL

Gluten-free food guide teaching

Intervention Type: BEHAVIORAL

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.

Standard of Care

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gluten-free food guide teaching

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children and adolescents, male and female, 5-18 years of age and their parents.
• Clinically diagnosed celiac disease
• Diagnosis within 3 months

Exclusion Criteria

• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Health services

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana R Mager

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Clinical Research Unit, University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 33745459 (View on PubMed)

Mager 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.

Reference Type: BACKGROUND

PMID: 34294170 (View on PubMed)

Other Identifiers

Pro00111071

Identifier Type: -

Identifier Source: org_study_id