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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 21 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether nutrition handouts, with or without a short video, help young people ages 10 to 21 with inflammatory bowel disease (IBD) eat fewer ultra-processed foods, such as packaged snacks and sugary drinks. Participants will report what they eat online, and families will share how useful they found the materials.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had IBD, a condition that causes swelling in the gut, for at least 3 months. This includes Crohn’s disease, ulcerative colitis, or IBD of an unknown type.
  • Be at least 10 years old and younger than 22 when joining.
  • See a gut specialist at Connecticut Children’s.
  • Have IBD in remission, meaning symptoms are under control, with a disease activity score called PUCAI or PCDAI below 10.
  • Receive IBD medicine through a vein at the CCMC Infusion Center.
  • Get all nutrition by mouth, without major diet limits or a need for nutrition supplements taken by mouth.

Who can't join

  • Follow a prescribed or restrictive diet, such as the Crohn’s Disease Exclusion Diet, keto, Specific Carbohydrate Diet, low FODMAP, gluten-free, paleo, or Whole30.
  • Get any nutrition through a feeding tube.
  • Have had bowel surgery within 3 months before the study starts that affects the ability to get normal nutrition through the gut.
  • Do not speak English, since the study will not offer translation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CT