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Behavioural Intervention
Gluten-Free Diet Education for Celiac Disease (GF-NOURISH Trial)
N/A
Waitlist Available
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 6 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to show the benefits of a nutrition education program that focuses on natural gluten-free foods and limits processed gluten-free foods. The study will assess whether this education program can improve health outcomes."
Who is the study for?
This trial is for individuals with Celiac Disease who may also be dealing with malnutrition or other nutrition disorders. The key eligibility criteria are not fully listed, but participants would typically need to have a confirmed diagnosis of Celiac Disease and possibly face nutritional challenges.
What is being tested?
The GF-NOURISH study is testing the effectiveness of a nutritional education program that emphasizes natural gluten-free foods while reducing ultra-processed gluten-free options. It aims to show how this approach can lead to better health outcomes for those with Celiac Disease.
What are the potential side effects?
Since this intervention involves dietary changes rather than medication, side effects might include digestive adjustments as the body adapts to new eating habits. Specific side effects are not listed but could vary based on individual reactions to diet changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass
Secondary study objectives
To compare the effect of GFFG versus conventional GFD on arsenic exposure
To compare the effect of GFFG vs conventional GFD class on diet quality
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: GFFGExperimental Treatment1 Intervention
Our Canadian collaborators have created Gluten Free-Food Guide (GFFG), a validated nutritional educational intervention, which targets increasing consumption of natural gluten free foods and limiting UPFs. However, this intervention has not yet been applied to a pediatric cohort in the United States. Preliminary data demonstrate enrollment feasibility and generalizability of the intervention. The GFFG arm will have increased focus on plant proteins, minimally processed food intake and fruit/vegetable intake with emphasis on naturally gluten-free foods. The GFFG class will highlight that not all gluten-free foods have the same nutritional and health benefits.
Group II: Conventional GFD Nutrition EducationActive Control1 Intervention
Diet counselling in both the conventional GFD nutrition education and the GFFG intervention arm will include concepts related to nutrition literacy (food label reading, gluten identification, nutritional adequacy). The control group will be provided with the GFFG at the end of the study.
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,827 Total Patients Enrolled
1 Trials studying Nutrition Disorders
30 Patients Enrolled for Nutrition Disorders