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Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD | Clinical Trials | Clareo Health

RECRUITING

Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD

NCT07224113•Connecticut Children's Medical Center

View on ClinicalTrials.gov

Summary

This study explores whether simple nutrition education can help children and teens with inflammatory bowel disease (IBD) eat fewer ultra-processed foods (UPFs). UPFs include packaged snacks, sugary drinks, and fast food-items that are high in added sugars, fats, and artificial ingredients. Participants will complete online food recalls to measure what they eat and will then receive either nutrition handouts alone or handouts plus a short educational video about UPFs. Researchers will compare changes in UPF intake between the two groups after several weeks and ask families how useful and acceptable they found the materials. The goal is to identify an effective, practical way to support healthier eating habits and long-term gut health in pediatric IBD.

Eligibility

Age

10 - 21 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Diagnosis of IBD (Crohn's disease, Ulcerative Colitis, IBD-U) for at least 3 months
•Age 10 through \< 22 years at the time of enrollment (i.e., up to the day before the 22nd birthday)
•Followed by a gastroenterologist at Connecticut Children's
•IBD in clinical remission based on calculated PUCAI score \<10 or PCDAI score of \<10
•Receiving medical infusions at CCMC Infusion Center as part of IBD treatment
•Participants must be on full oral intake and not have major dietary restrictions or require oral nutrition supplements

Exclusion Criteria

•Following a medically prescribed or restrictive diet such as Crohn's Disease Exclusion Diet (CDED), ketogenic diet, Specific Carbohydrate Diet (SCD), low FODMAP diet, gluten-free diet, paleo, or Whole30.
•Receiving any nutrition through feeding tubes (including nasogastric \[NG\], nasojejunal \[NJ\], gastrostomy \[G\], or gastrojejunostomy \[GJ\] tubes)
•History of bowel surgery within 3 months of study start affecting ability to sustain normal enteral intake
•Non-English-speaking participants (as translation and short-form consent processes will not be used for this study)

Locations (1)

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Key Dates

Start Date

November 10, 2025

Primary Completion Date

May 1, 2026

Completion Date

July 30, 2026

Last Updated

November 19, 2025

Enrollment

120

ESTIMATED participants

Conditions

IBDCrohn Disease (CD)Ulcerative Colitis (UC)Inflammatory Bowel Disease (IBD)Ultra Processed FoodNutrition AssessmentDGBI

Interventions

Handout-Only Intervention

BEHAVIORAL

Handout + Video Intervention

BEHAVIORAL

Contacts

Giselle M Davila Bernardy, MD

CONTACT

8605459560 gdavilabernardy@connecticutchildrens.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD

Inclusion Criteria

Exclusion Criteria

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