Recruiting

Nutrition Education

Sponsor:

Connecticut Children's Medical Center

Code:

NCT07224113

Conditions

IBD

Crohn Disease (CD)

Ulcerative Colitis (UC)

Inflammatory Bowel Disease (IBD)

Ultra Processed Food

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Accepted

Interventions

Handout-Only Intervention

Handout + Video Intervention

Study Details

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

Study ID

NCT07224113

Start date

Nov 10, 2025

Status verified date

Nov, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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

Participants receive written nutrition handouts explaining what ultra-processed foods (UPFs) are, how to identify them, and practical strategies to reduce UPF intake.

Handout + Video Intervention

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

Primary outcome measure

  • Change in Ultra-Processed Food (UPF) Intake [ Time Frame: Baseline and follow-up within a 4-12 week window after intervention ]

Central Contacts and Locations

Central contacts

Giselle M Davila Bernardy, MD

8605459560gdavilabernardy@connecticutchildrens.org

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Giselle Davila-Bernardy, MD

8605459560gdavilabernardy@connecticutchildrens.org

Principal Investigator:

Giselle M Davila-Bernardy, MD

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Jul 16, 2026

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2026-07-16.