NCT07224113 Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
| NCT ID | NCT07224113 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Connecticut Children's Medical Center |
| Condition | IBD |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-10 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-11-10 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Giselle Davila-Bernardy, MD
PRINCIPAL INVESTIGATOR
Connecticut Children's Medical Center
Frequently Asked Questions
Who can join the NCT07224113 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 21 Years, studying IBD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07224113 currently recruiting?
Yes, NCT07224113 is actively recruiting participants. Contact the research team at gdavilabernardy@connecticutchildrens.org for enrollment information.
Where is the NCT07224113 trial being conducted?
This trial is being conducted at Hartford, United States.
Who is sponsoring the NCT07224113 clinical trial?
NCT07224113 is sponsored by Connecticut Children's Medical Center. The principal investigator is Giselle Davila-Bernardy, MD at Connecticut Children's Medical Center. The trial plans to enroll 120 participants.