A Feasibility Study on Different Health Education Delivery Methods for a Low Fermentable Carbohydrate (FODMAP) Diet in Patients With Functional Bowel Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- RETENTION RATE (overall and within each study group)
研究概览
简要总结
There is evidence for the use of a diet low in short chain fermentable carbohydrates (low FODMAP diet) in the management of functional gut symptoms, such as abdominal pain and bloating. However, the provision of advice on the low FODMAP diet can be challenging due to limited resources and the need for a dietitian with expertise in the low FODMAP diet. The aim of this study is to assess the feasibility in terms of recruitment and retention in planning a future trial. The purpose of the future trial will be to investigate the clinical and cost effectiveness, as well as the acceptability of different education methods of the low FODMAP diet for the treatment of IBS.
To date, there are no studies on the implementation of the low FOMDAP diet using a mobile app or leaflets in the education of the low FODMAP diet. Therefore, a feasibility study design was chosen in order to obtain key data on recruitment and retention rates at each study group.
详细描述
A low FODMAP diet includes FODMAP restriction, FODMAP re-introduction and FODMAP personalisation. This study will focus on FODMAP restriction whereby foods high in FODMAPs are avoided for 4 weeks.
Patients with IBS will be recruited from primary and secondary care centres.
STUDY GROUPS
Group 1: 2 x Booklets produced produced by the Department of Nutrition and Dietetic in Guy's & St Thomas' NHS Foundation Trust, and the Diabetes and Nutritional Sciences Division at King's College London. These booklets have been produced by dietitians and are commonly used in clinical practice across the UK. They contain the following information:
Group 2: Patients will be asked to download an application on their mobile phones or tablets. This application has been produced by dietitians from the Department of Nutrition and Dietetic in Guy's & St Thomas' NHS Foundation Trust, and the Diabetes and Nutritional Sciences Division at King's College London.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Men and women aged 18 or over with IBS, functional diarrhoea or functional bloating based on Rome IV criteria who do not have a major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous GI surgery, except cholecystectomy and haemorrhoidectomy
- •Individuals with no adequate relief of their symptoms at baseline, as well as those with frequency of abdominal pain or discomfort for 1 or more days/week.
- •Individuals with a BMI of 18.5 kgm2 or more.
- •Individuals able to give informed consent
- •Individuals able to understand English
- •Individuals able to read English
- •Individuals with access to Internet
- •Individuals with smartphone with Android or IOS (Apple) software who are able to download apps.
排除标准
- •Females who report to be pregnant or lactating
- •Individuals with constipation predominant IBS (IBS-C) based on the Rome IV criteria
- •Consumption of antibiotics, in the last 4 weeks prior to the study
- •Individuals with additional specific dietary needs (based on the dietitian's judgment)
- •Individuals with multiple food allergies
- •Individuals who have participated in other trials with investigational products within 3 months prior to screening
研究组 & 干预措施
Booklets
Health education delivery method: Booklet. Patients will be given 2 leaflets on the low FOMDAP diet produced by the Department of Nutrition and Dietetic in Guy's & St Thomas' NHS Foundation Trust, and the Diabetes and Nutritional Sciences Division at King's College London. These booklets have been produced by dietitians and are commonly used in clinical practice across the UK.
干预措施: Health education delivery methods (Other)
Mobile application
Health education delivery method: Mobile application. Patients will be asked to download an application on their mobile phones or tablets. This application has been produced by dietitians from the Department of Nutrition and Dietetic in Guy's & St Thomas' NHS Foundation Trust, and the Diabetes and Nutritional Sciences Division at King's College London.
干预措施: Health education delivery methods (Other)
One to one consultation with dietitian
Health education delivery method:One-to-one consultation with dietitian. Patients will attend a clinic visit for a one-to-one consultation with a dietitian. As per current clinical practice, the initial visit will last for 1 hour. During the visit, tailored information on the low FOMDAP diet will be given to match patients' individual needs. During the visit, either the leaflets (used in group 1) or the application (used in group 2) will be used to facilitate the visit. The choice of using the leaflets or the app during the visit will be based on the dietitian's judgment based on the patients' needs.
干预措施: Health education delivery methods (Other)
结局指标
主要结局
RETENTION RATE (overall and within each study group)
时间窗: Follow-up visit (week 4)
Retention rate of patients receiving different education delivery methods of the low FODMAP diet.
RECRUITMENT RATE
时间窗: Baseline visit (Day 0)
Recruitment rate of patients receiving different education delivery methods of the low FODMAP diet.
次要结局
- Appropriateness of the education methods received in each study group(Baseline (Day 0) and Follow-up visit (week 4))
- Perceived fit of the education delivery methods within the NHS(Follow-up visit (week 4))
- Willingness of participants being assigned to the study groups using a multiple choice questionnaire.(Follow-up visit (week 4))
- Gastrointestinal symptom severity(Baseline (Day 0) and Follow-up visit (week 4))
- Estimates of the parameters required for calculation of the sample size for a future larger study(Screening (Week -1), Baseline (Day 0) and Follow-up visit (week 4))
- Compliance rates to the diet(Follow-up visit (week 4))
- Health-related quality of life in irritable bowel syndrome(Baseline (Day 0) and Follow-up visit (week 4))
- Gastrointestinal symptoms experienced(Baseline and follow-up visitBaseline (Day 0) and Follow-up visit (week 4))
- Adequate relief of symptoms(Baseline (Day 0) and Follow-up visit (week 4))
- Satisfaction over the education delivery methods received(Baseline (Day 0) and Follow-up visit (week 4))