Understanding Patient's Barriers and Perceived Benefits Through Adherence to Nutritional Interventions in IBD: a Preliminary Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- To identify IBD's top three patients' barriers to access and follow the nutritional intervention.
研究概览
简要总结
In this study, we are trying to learn how certain diets affect people with inflammatory bowel disease (IBD). We want to understand what makes it hard or easy for them to stick to different eating plans, like intermittent fasting, the Mediterranean diet, and the Low FODMAP diet. By finding out how these diets help with symptoms and which ones are easier to follow, we hope to improve the quality of life for people with IBD.
详细描述
This study aims to explore the impact of specific dietary interventions on individuals living with inflammatory bowel disease (IBD). By examining dietary patterns such as intermittent fasting, the Mediterranean diet, and the Low FODMAP diet, we seek to identify barriers to adherence and facilitators that make these eating plans sustainable. Additionally, we aim to evaluate the perceived benefits of these diets in managing IBD symptoms and their influence on overall quality of life. The findings will provide valuable insights to develop patient-centered nutritional strategies that enhance adherence and therapeutic outcomes in IBD care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18+ years) diagnosed with ulcerative colitis or Crohn's disease.
- •Having willingness to use their personal smartphone to access the app
- •Able to understand the indication by the registered dietitian.
- •Able to provide informed consent.
- •Willingness to attempt intervention diet and commit to study procedures.
排除标准
- •Pregnant women.
- •Currently being treated for eating disorders, schizophrenia, psychosis, or other acute mental disorders.
- •Currently being treated for chemotherapy.
- •Advance chronic kidney disease
- •Short bowl syndrome
研究组 & 干预措施
Mediterranean Diet
Participants will be assigned to follow a Mediterranean diet.
Low FODMAP Diet
Participants will be assigned to follow a Low FODMAP Diet.
干预措施: Low FODMAP Diet Intervention (Other)
Intermittent Fasting
Participants will be assigned to follow an intermittent fasting protocol.
结局指标
主要结局
To identify IBD's top three patients' barriers to access and follow the nutritional intervention.
时间窗: From enrollment to the end of the study and at 5 weeks
The outcome will be assessed through semi-structured one-on-one interviews conducted at the end of the study. Interviews will last approximately 40 minutes to 1 hour and will follow a structured interview guide with open-ended questions, designed to explore participants' experiences, perceptions, and challenges in accessing and adhering to the nutritional intervention. Interviews will be audio-recorded and transcribed verbatim. Data will be analyzed using thematic analysis informed by interpretive description methodology, to identify key personal and systemic barriers. NVivo software (QSR International) will be used to facilitate qualitative coding and analysis.
次要结局
- To identify specific sociodemographic criteria that may act as a deterrent or facilitator in the ability to generate honest qualitative data through questionnaires and an individual interview.(From enrollment to the end of the study and at 5 weeks)
- To identify adherence to each food intervention through the use of an app (RxFood) and different questionnaires.(From enrollment to the end of the study and at 5 weeks)
研究者
David Armstrong
Principal Investigator
McMaster University