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Behavioural Intervention

GFFG for Nutrition Disorders (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

GF-NOURISH Trial 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.Check my eligibility
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.See study design
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.

GF-NOURISH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 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
To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass
Secondary outcome measures
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

GF-NOURISH 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.

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Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
764 Previous Clinical Trials
5,580,559 Total Patients Enrolled
1 Trials studying Nutrition Disorders
30 Patients Enrolled for Nutrition Disorders

Frequently Asked Questions

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

Which individuals are eligible to participate in this research study?

"To be considered for inclusion in this research study, subjects must have a confirmed diagnosis of celiac disease and be between the ages of 2 to 18 years. The trial aims to enroll approximately 120 participants."

Answered by AI

Is this medical study currently open for enrollment?

"The information found on clinicaltrials.gov states that the current trial is not actively seeking participants. The initial posting date was 7/1/2024, with the most recent update occurring on 4/4/2024. Despite this trial being inactive in terms of recruitment, there are currently 95 alternative trials actively seeking suitable candidates."

Answered by AI

Is there an age restriction for participants above 55 years old in this research study?

"Prospective participants must be between 2 and 18 years of age to meet the entry requirements for this clinical investigation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Nan Du 2024. "GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06356220.
All > Celiac Disease
~80 spots leftby Jan 2026
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