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Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric IBD

This study is looking at whether nutrition education can help children and teens (ages 10-21) with Inflammatory Bowel Disease (IBD), including Crohn's disease and Ulcerative Colitis, eat fewer ultra-processed foods (UPFs). UPFs are foods like packaged snacks and sugary drinks. Participants will receive either a Handout-Only Intervention (written materials) or a Handout + Video Intervention (written materials plus a short video) to learn about UPFs and healthier eating. Researchers will measure changes in UPF intake after 4-12 weeks to see if these interventions are successful in helping patients make healthier food choices. The study aims to find practical ways to support better eating habits and long-term gut health in young people with IBD.

Study design
This is an observational study planning to enroll 120 participants. It compares two groups receiving different educational interventions.
What's involved
You would complete online food recalls and receive either nutrition handouts or handouts plus a video. Your UPF intake will be measured at the start and again 4-12 weeks later.
Compensation
Not stated in the trial record.
Follow-up
Your ultra-processed food intake will be measured at follow-up within a 4-12 week window after the intervention.

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NCT07224113

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

Recruiting
Not specifiedAges 10–21Observational
Connecticut Children's Medical Center
~120 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Handout-Only InterventionHandout + Video Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Ultra-Processed Food (UPF) Intake
Measured over Baseline and follow-up within a 4-12 week window after intervention

Conditions

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

Explore related trials

Crohn DiseaseInflammatory Bowel DiseaseUlcerative Colitis

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Giselle Davila-Bernardy, MD · PRINCIPAL_INVESTIGATOR · Connecticut Children's Medical Center

Who to contact

Giselle M Davila Bernardy, MD
[email protected]
8605459560
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change in Ultra-Processed Food (UPF) IntakeBaseline and follow-up within a 4-12 week window after intervention

    Description: Percent of total daily energy from NOVA Group 4 foods, comparing baseline to follow-up.