Actively Recruiting
Assessment and Educational Intervention to Reduce Ultra-Processed Food Consumption in Pediatric Patients With IBD
Led by Connecticut Children's Medical Center · Updated on 2025-11-19
120
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether simple nutrition education can help children and teens with inflammatory bowel disease (IBD) reduce their intake of ultra-processed foods (UPFs). UPFs include packaged snacks, sugary drinks, and fast food items that are high in added sugars, fats, and artificial ingredients. The study aims to find an effective and practical way to support healthier eating habits and improve long-term gut health in pediatric IBD patients. Participants are divided into three groups: one group receives written nutrition handouts explaining UPFs and how to choose less-processed alternatives; another group receives both the handouts and a short educational video reinforcing key messages about UPFs and healthy eating; and a comparison group of children and teens with disorders of gut-brain interaction completes dietary assessments without receiving educational materials. The interventions are behavioral and delivered as educational tools. During the study, participants will complete online food recalls to measure what they eat. Researchers will compare changes in UPF intake between groups within a 4 to 12 week window after the intervention. Families will also be asked about the usefulness and acceptability of the materials. The study is sponsored by Connecticut Children's Medical Center and involves children and teens aged 10 to under 22 years, with participation lasting several weeks after enrollment.
CONDITIONS
Brief Title
Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of IBD (Crohn's disease, Ulcerative Colitis, IBD-U) for at least 3 months
- Age 10 through less than 22 years at enrollment
- Followed by a gastroenterologist at Connecticut Children's
- IBD in clinical remission with PUCAI score less than 10 or PCDAI score less than 10
- Receiving medical infusions at CCMC Infusion Center as part of IBD treatment
- On full oral intake without major dietary restrictions or need for oral nutrition supplements
You will not qualify if you...
- 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 nutrition through feeding tubes including nasogastric, nasojejunal, gastrostomy, or gastrojejunostomy tubes
- History of bowel surgery within 3 months before study start affecting normal enteral intake
- Non-English-speaking participants due to consent process limitations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 12 weeks
Participants receive educational interventions to reduce ultra-processed food consumption. This includes either written nutrition handouts alone or handouts combined with a short educational video.
1 baseline visit and 1 follow-up visit within 4 to 12 weeks after intervention
Trial Site Locations
Total: 1 location
1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
Research Team
G
Giselle M Davila Bernardy, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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