Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Ultra-Processed Food (UPF) Intake
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change in Ultra-Processed Food (UPF) Intake
时间窗: 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.
次要结局
未报告次要终点
研究者
Giselle Davila Bernardy
MD
Connecticut Children's Medical Center