Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Handout-Only Intervention, Handout + Video Intervention.
- Who it may be relevant to
- Registry conditions: IBD, Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD). Basic parameters: 10 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Handout-Only Intervention
Participants receive written nutrition handouts explaining what ultra-processed foods (UPFs) are, how to identify them, and practical strategies to reduce UPF intake. - Behavioral Handout + Video Intervention
Participants receive the same nutrition handouts plus a short educational video reinforcing key messages about UPFs and healthy eating choices.
Primary outcome measures
- Change in Ultra-Processed Food (UPF) Intake [Time frame: Baseline and follow-up within a 4-12 week window after intervention]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Connecticut Children's Medical Center — Hartford
Identifiers
NCT: NCT07224113 · 25-114