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

NCT06038344 | Active Not Recruiting

• 1 other identifier: Pro00111071
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Gluten-Free Food Guide; Dietary Education; Dietary Quality; Celiac Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (6)

• Self-reported adherence to the gluten-free diet.

  Baseline

• Self-reported adherence to the gluten-free diet

  6 months

• Gluten intake

  Baseline

• Gluten intake

  6 months

• Parental Nutrition Literacy

  Baseline

Study Arms (2)

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.

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).

Interventions

Gluten-free food guide teaching 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 + Gluten-free food guide teaching

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Clinical Research Unit, University of Alberta

Edmonton, Alberta, T6G 0K2, Canada

Location

Related Publications (2)

• 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.

  PMID: 33745459 BACKGROUND

• 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.

  PMID: 34294170 BACKGROUND

MeSH Terms

Conditions

Celiac Disease; Malnutrition; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders; Health Behavior; Behavior

Study Officials

• Diana R Mager

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 14, 2023
• Study Start: June 22, 2021
• Primary Completion: January 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)