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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-21
SponsorConnecticut Children's Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Children, adolescents, and young adults (ages 8-21 years) with inflammatory bowel disease or a disorder of gut-brain interaction receiving care at Connecticut Children's. Participants will complete dietary recalls and brief surveys to evaluate nutrition education about ultra-processed foods.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: IBD Handout-Only Group1 intervention
Group B: IBD Handout + Video Group1 intervention
Group C: DGBI Control Group0 interventions

Trial outcomes

Primary outcomes

1

Change in Ultra-Processed Food (UPF) Intake

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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