NCT07224113 · Connecticut Children's Medical Center
Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Hartford, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations