Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Proportion of patients who accepted invitation to participate as a marker of feasibility
研究概览
简要总结
Cystic Fibrosis (CF) is a lifelong condition which causes the lungs and digestive system to become clogged with thick, sticky mucus. This leads to recurrent lung infections and reduced nutrients absorption from food. The average age at death is 26 years, usually from respiratory failure. Nonetheless, the nutritional status of people with CF (PWCF) is important help them live healthier and longer.
It is recommended that adult with CF achieve a BMI of 23 for males and 22 for females. However, fewer than 50% adult with CF achieved that target BMI despite effective nutritional support to help support weight gain. There is a clear need for a behavioural intervention that can help PWCF use the available nutritional support.
This is a feasibility study to try out a multi-component behavioural intervention. The intervention is designed to help PWCF use their nutritional support to gain weight. It will focus on testing the methods and procedures to be used on a larger scale, improving the behavioural intervention and estimating the how many people are needed for the larger trial.
All eligible 75 PWCF in Sheffield will be invited to participate. The investigators anticipate recruiting 30 participants. Participants will be divided into two groups. The first group receive the behavioural intervention immediately. The second group receive the intervention after 3 months. All participants will be followed up for 6 months. Data will be collected every 6 weeks during clinic reviews.
These two groups will be compared against each other to estimate the potential impact of the behavioural intervention. The investigators will also interview some of the participants at the end of the study period to improve the intervention and the study processes based on participant feedback.
The investigators hypothesised that this study will recruit around 30 participants, around 80% of the participants will complete the study, a single full-time investigator can deliver the intervention to 15 participants over 3 months and data collection will be thorough (with less than 5% missing data). The investigators also hypothesised that this feasibility study will help improve the intervention and help the design of a larger trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult people with CF looked after at the Sheffield Adult CF Unit
- •best BMI of < 23 for males and < 22 for females between Oct '12 and Oct '13
排除标准
- •patients in the palliative phase of disease
- •patients who are pregnant
- •patients who have no capacity to consent to participate in the study
- •patients who have no IT facilities to use the web-based food diary
- •patients who are unable to communicate by telephone for coaching
结局指标
主要结局
Proportion of patients who accepted invitation to participate as a marker of feasibility
时间窗: 4 weeks
Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility
时间窗: 4 weeks
次要结局
- Resources needed by the investigators to deliver the intervention(6 months)
- Participants' opinion about the behavioural intervention(6 months)
- Participant attrition rate and phases of study whereby the attrition occurs(6 months)
- Proportion of days with missing nutritional data, as a marker for feasibility(6 months)
- Participants' opinion about the study processes(6 months)
- Participants' suggestions for further improvement of the intervention and study processes(6 months)
- Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities(2 weeks)