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

NCT07224113 | Recruiting

• 1 other identifier: 25-114
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

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

Study Arms (3)

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

Handout-Only Intervention BEHAVIORAL

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-Only Group

Handout + Video Intervention BEHAVIORAL

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

IBD Handout + Video Group

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Giselle Davila-Bernardy, MD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giselle M Davila Bernardy, MD

CONTACT

8605459560; gdavilabernardy@connecticutchildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: November 10, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)