Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in Ultra-Processed Food (UPF) Intake
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Whole
- •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)
Arms & Interventions
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.
Intervention: Handout-Only Intervention (Behavioral)
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.
Intervention: Handout + Video Intervention (Behavioral)
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Giselle Davila Bernardy
MD
Connecticut Children's Medical Center