Reducing ultra-processed foods in children and teens with IBD
Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
This project will test whether short nutrition handouts or handouts plus a brief video can help children and teens with IBD eat fewer ultra-processed foods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 10 Years to 21 Years |
| Sex | All |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT07224113 on ClinicalTrials.gov |
What this trial studies
Participants with pediatric IBD will complete online 24-hour food recalls to measure baseline ultra-processed food (UPF) intake and then receive either nutrition handouts alone or handouts plus a short educational video about UPFs. Intake will be re-measured after several weeks to compare changes in UPF consumption between the two groups. Families will also complete questionnaires about how useful and acceptable they found the materials. The study focuses on patients followed at Connecticut Children's who are in clinical remission and receiving routine infusions.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents age 10–21 with a confirmed IBD diagnosis for at least 3 months who are in clinical remission, followed by a gastroenterologist at Connecticut Children's, receiving infusions at the CCMC Infusion Center, and able to eat orally without major dietary restrictions.
Not a fit: Patients on medically prescribed or restrictive diets, receiving nutrition via feeding tubes, or with recent bowel surgery are excluded and likely would not benefit from these general education materials.
Why it matters
Potential benefit: If successful, this simple education could help young people with IBD reduce UPF intake and support healthier long-term gut outcomes.
How similar studies have performed: Some general-population and adult studies show education can lower UPF intake, but few trials have directly tested brief educational interventions specifically in pediatric IBD.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Hartford, Connecticut
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Giselle Davila-Bernardy, MD — Connecticut Children's Medical Center
- Study coordinator: Giselle M Davila Bernardy, MD
- Email: gdavilabernardy@connecticutchildrens.org
- Phone: 8605459560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.