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NCT Number: NCT07224113

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.

Recruiting

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Key information

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location status: Recruiting

Location contact

Giselle Davila-Bernardy, MD

CONTACT

[email protected]

8605459560

Giselle M Davila-Bernardy, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Handout + Video Intervention

Behavioral

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

Primary outcomes

  1. Change in Ultra-Processed Food (UPF) Intake

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

    Description: Percent of total daily energy from NOVA Group 4 foods, comparing baseline to follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Giselle M Davila Bernardy, MD

CONTACT

[email protected]

8605459560

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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