IBDNCT07224113
Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
An observational study of IBD and Crohn Disease (CD), run by Connecticut Children's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD, Crohn Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- Handout-Only Intervention and Handout + Video Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Giselle Davila-Bernardy, MD, 8605459560, gdavilabernardy@connecticutchildrens.org
Giselle M Davila-Bernardy, MD
About this study
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.
- Conditions
- IBD, Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Ultra Processed Food, Nutrition Assessment
- Being tested
- Handout-Only Intervention, Handout + Video Intervention
- Keywords
- IBD, Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Ultra processed food
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handout-Only InterventionBehavioural
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 InterventionBehavioural
Participants receive the same nutrition handouts plus a short educational video reinforcing key messages about UPFs and healthy eating choices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Handout-Only Intervention | |
| 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. Receives: Behavioral: Handout + Video Intervention | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ultra-Processed Food (UPF) Intake
Description: Percent of total daily energy from NOVA Group 4 foods, comparing baseline to follow-up.
Measured: Baseline and follow-up within a 4-12 week window after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start10 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Davila Bernardy, Connecticut Children's Medical Center
- Investigators
- Giselle Davila-Bernardy, MD, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224113
- Sponsor's protocol ID
- 25-114
- Status last verified
- Nov 2025
- First submitted
- 31 Oct 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
- ClinicalTrials.gov ID
- NCT07224113
- Acronym / sponsor ID
- 25-114
- Conditions
- IBD, Crohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), Ultra Processed Food, Nutrition Assessment
- Keywords
- IBD, Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Ultra processed food
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD Handout-Only Group | – | Behavioral: Handout-Only InterventionChildren 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. |
| IBD Handout + Video Group | – | Behavioral: Handout + Video InterventionChildren 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. |
| 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. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handout-Only InterventionParticipants receive written nutrition handouts explaining what ultra-processed foods (UPFs) are, how to identify them, and practical strategies to reduce UPF intake. | Behavioural | IBD Handout-Only Group |
| Handout + Video InterventionParticipants receive the same nutrition handouts plus a short educational video reinforcing key messages about UPFs and healthy eating choices. | Behavioural | IBD Handout + Video Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giselle Davila-Bernardy, MD principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Crohn Disease (CD), run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giselle M Davila Bernardy, MD (8605459560, gdavilabernardy@connecticutchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ultra-Processed Food (UPF) Intake (time frame: Baseline and follow-up within a 4-12 week window after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.