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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Connecticut Children's Medical Center
Study ID
NCT07224113
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
10 Years - 21 Years
Healthy Volunteers
Accepted

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.
  • Handout + Video Intervention — BEHAVIORAL
    Participants receive the same nutrition handouts plus a short educational video reinforcing key messages about UPFs and healthy eating choices.

Study Details

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.

Key Dates

Start date
Nov 10, 2025
Status verified
Nov 2025
Primary completion
May 1, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Children's Medical CenterHartfordConnecticut06106
Giselle Davila-Bernardy, MD
[email protected]
8605459560
Giselle M Davila-Bernardy, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Connecticut Children's Medical Center· Hartford, CT

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