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

Connecticut Children's Medical Center

Status: Enrolling

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

Treatments: Behavioral: Handout-Only Intervention; Behavioral: Handout + Video Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07224113

25-114

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 10 to 21 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

120 participants in 3 patient groups

IBD Handout-Only Group

Description:

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.

Treatment:

Behavioral: Handout-Only Intervention

IBD Handout + Video Group

Description:

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.

Treatment:

Behavioral: Handout + Video Intervention

DGBI Control Group

Description:

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.