Recruiting

GF-NOURISH

Sponsor:

Boston Children's Hospital

Code:

NCT06356220

Conditions

Celiac Disease in Children

Nutrition Disorder, Child

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Gluten-Free Diet Education

Study Details

Brief summary:

The investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits

Conditions

Celiac Disease in Children

Nutrition Disorder, Child

Study ID

NCT06356220

Start date

Apr 29, 2025

Status verified date

Oct, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 2-18 years of age with recent celiac disease diagnosis

Exclusion Criteria:

  • Allergic to <3 of the top 8 food allergens
  • Co-morbid conditions treated with dietary modifications or that influence nail arsenic values

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: GFFG

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.

active comparator: Conventional GFD Nutrition Education

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.

Interventions

Gluten-Free Diet Education

The two groups will receive different gluten free diet education interventions. Currently, virtual GFD education classes are the standard of care for educating children with CeD and their families about GFD at Boston Children's Hospital. Thus, all diet education (including GFFG intervention) will be provided virtually by Registered Dietitians with expertise in GFDs. .

Primary outcome measure

  • To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass [ Time Frame: Over 6 months ]

Central Contacts and Locations

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Lauren Robertson

6173556000lauren.robertson@childrens.harvard.edu

Principal Investigator:

Nan Du, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.