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

NCT ID: NCT07224113

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-10
• Study Completion Date: 2026-07-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Handout-Only Intervention

Intervention Type: 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 + 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.

Handout + Video Intervention

Intervention Type: BEHAVIORAL

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Handout + Video Intervention

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Giselle Davila Bernardy

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giselle Davila-Bernardy, MD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Center

Locations

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Giselle M Davila Bernardy, MD

Role: CONTACT

gdavilabernardy@connecticutchildrens.org

8605459560

Facility Contacts

Giselle Davila-Bernardy, MD

Role: primary

gdavilabernardy@connecticutchildrens.org

8605459560

Other Identifiers

25-114

Identifier Type: -

Identifier Source: org_study_id