Crohn'sUCRecruiting
Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
Observational · No treatment assigned · 1 site · Connecticut Children's Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: IBD, Crohn Disease (CD) and Ulcerative Colitis (UC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 10 to 21
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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
Plus 3 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2025-11-10.
- Main results expected around 2026-12-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Change in Ultra-Processed Food (UPF) Intake (Baseline and follow-up within a 4-12 week window after intervention)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | IBD; Crohn Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Disease (IBD); Ultra Processed Food; Nutrition Assessment; DGBI |
| Lead sponsor | Connecticut Children's Medical Center |
| Enrollment | 120 (estimated) |
| Start date | 2025-11-10 |
| Primary completion (est.) | 2026-12-01 |
| First posted | 2025-11-04 |
| Last updated | 2026-07-16 |
| Official title | Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD |
| ClinicalTrials.gov ID | NCT07224113 |
Interventions
- Handout-Only Intervention (Behavioral)
Participants receive written nutrition handouts explaining what ultra-processed foods (UPFs) are, how to identify them, and practical strategies to reduce UPF intake. - Handout + Video Intervention (Behavioral)
Participants receive the same nutrition handouts plus a short educational video reinforcing key messages about UPFs and healthy eating choices.
Full eligibility criteria (from the record)
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)
| Site | City | Country | Site status |
|---|---|---|---|
| Connecticut Children's Medical Center | Hartford, Connecticut | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.