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

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.

Study Overview

• Status: Recruiting
• Conditions: IBD; Inflammatory Bowel Disease (IBD); Nutrition Assessment; Crohn Disease (CD); Ulcerative Colitis (UC); Ultra Processed Food; DGBI
• Intervention / Treatment: Behavioral: Handout-Only Intervention; Behavioral: Handout + Video Intervention

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Giselle M Davila Bernardy, MD; Phone Number: 8605459560; Email: gdavilabernardy@connecticutchildrens.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Connecticut Children's Medical Center
      • Principal Investigator: Giselle M Davila-Bernardy, MD
      • Contact: Giselle Davila-Bernardy, MD; Phone Number: 8605459560; Email: gdavilabernardy@connecticutchildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participants receive written nutrition handouts explaining what ultra-processed foods (UPFs) are, how to identify them, and practical strategies to reduce UPF intake.
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; Participants receive the same nutrition handouts plus a short educational video reinforcing key messages about UPFs and healthy eating choices.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ultra-Processed Food (UPF) Intake	Description: Percent of total daily energy from NOVA Group 4 foods, comparing baseline to follow-up.	Baseline and follow-up within a 4-12 week window after intervention

Collaborators and Investigators

• Sponsor: Connecticut Children's Medical Center
• Investigators: Principal Investigator: Giselle Davila-Bernardy, MD, Connecticut Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: November 3, 2025
• First Posted (Estimated): November 4, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; IBD; Crohn Disease; Ultra processed food
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: 25-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No