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

Connecticut Children's Medical Center · NCT07224113

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 10–21 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
120
US sites recruiting
1
Study start
November 10, 2025
Record last updated
July 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Handout-Only Intervention; Handout + Video Intervention

Conditions: IBD; Crohn Disease (CD); Ulcerative Colitis (UC); Inflammatory Bowel Disease (IBD); Ultra Processed Food; Nutrition Assessment; DGBI

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)

Recruiting US locations

  • Connecticut Children's Medical Center

    Hartford, CT 06106

    Site contact: Giselle Davila-Bernardy, MD · 8605459560 · gdavilabernardy@connecticutchildrens.org

Study contacts (from the official record)

  • Giselle M Davila Bernardy, MD · 8605459560 · gdavilabernardy@connecticutchildrens.org
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Assessment and Educational Intervention to Reduce Ultra-processed… (NCT07224113) | Bored Studies