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RecruitingNCT07224113Updated Jul 16, 2026

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

An observational study in IBD, Crohn Disease (CD) and Ulcerative Colitis (UC), sponsored by Connecticut Children's Medical Center. Recruiting at 1 site in United States. Open to participants aged 10 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Connecticut Children's Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
10 Years to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • IBD
  • Inflammatory Bowel Disease
  • Crohn Disease
  • Ulcerative Colitis
  • Ultra processed food
03

Who can participate

Ages eligible
10 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children, adolescents, and young adults (ages 8-21 years) with inflammatory bowel disease or a disorder of gut-brain interaction receiving care at Connecticut Children's. Participants will complete dietary recalls and brief surveys to evaluate nutrition education about ultra-processed foods.

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

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • IBD Handout-Only Group

    Children and teens with inflammatory bowel disease (Crohn's disease or ulcerative colitis) who receive written nutrition handouts explaining what ultra-processed foods (UPFs) are, common examples, and ways to choose less-processed alternatives.

    Behavioral: Handout-Only Intervention

  • IBD Handout + Video Group

    Children and teens with inflammatory bowel disease who receive both written handouts and a short educational video reinforcing key messages about UPFs, healthy eating, and simple strategies to improve diet quality.

    Behavioral: Handout + Video Intervention

  • DGBI Control Group

    Children and teens with disorders of gut-brain interaction (such as functional abdominal pain or irritable bowel syndrome) who complete the same dietary assessments but do not receive educational materials. This group provides comparison data for baseline dietary patterns.

Interventions

  • BehavioralHandout-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.

  • BehavioralHandout + Video Intervention

    Participants receive the same nutrition handouts plus a short educational video reinforcing key messages about UPFs and healthy eating choices.

05

What researchers measure

Primary outcomes

  1. Change in Ultra-Processed Food (UPF) Intake

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

    Time frame: Baseline and follow-up within a 4-12 week window after intervention

06

Study locations

1 of 1 sites recruiting
  • Connecticut Children's Medical Center
    Hartford, Connecticut 06106, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07224113
Lead sponsor
Connecticut Children's Medical Center
Responsible party
Giselle Davila Bernardy (MD, Connecticut Children's Medical Center) — Principal investigator
First posted
Nov 4, 2025
Start date
Nov 10, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Jul 16, 2026

Study contacts

Giselle M Davila Bernardy, MD
Contact
gdavilabernardy@connecticutchildrens.org
8605459560
Giselle Davila-Bernardy, MD
principal investigator · Connecticut Children's Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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