Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis (PIN-CF)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
South Yorkshire
-
Sheffield、South Yorkshire、英国、S5 7AU
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Behaviour change intervention
Intensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months
|
The behaviour change intervention consists of
The intensive intervention phase consists of 2 home visits, 8 telephone calls and 6 reminder emails. The maintenance phase consists of 3 telephone calls and 4 reminder emails. |
其他:Wait-list Control
Usual care for 3 months, followed by intensive behaviour change intervention for 3 months
|
The behaviour change intervention consists of
The intensive intervention phase consists of 2 home visits, 8 telephone calls and 6 reminder emails. The maintenance phase consists of 3 telephone calls and 4 reminder emails. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
接受邀请参加作为可行性标志的患者比例
大体时间:4周
|
4周
|
Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility
大体时间:4 weeks
|
4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Participants' opinion about the behavioural intervention
大体时间:6 months
|
6 months
|
|
Participant attrition rate and phases of study whereby the attrition occurs
大体时间:6 months
|
6 months
|
|
Participants' opinion about the study processes
大体时间:6 months
|
6 months
|
|
Participants' suggestions for further improvement of the intervention and study processes
大体时间:6 months
|
6 months
|
|
Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
大体时间:2 weeks
|
2 weeks
|
|
Resources needed by the investigators to deliver the intervention
大体时间:6 months
|
6 months
|
|
Proportion of days with missing nutritional data, as a marker for feasibility
大体时间:6 months
|
Participants are requested to fill in their nutritional intake daily on a web-based food diary.
The investigators are interested to find out what the proportion of such data will be missing to determine the feasibility of collecting data with the web-based food diary.
|
6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Body mass index
大体时间:6 months
|
Unit is kg/m2
|
6 months
|
Weight
大体时间:6 months
|
unit is kg
|
6 months
|
Beliefs about Medicines Questionnaire (BMQ) score
大体时间:6 months
|
As a marker of patients' perception of their treatment
|
6 months
|
The mean Self-Report Behavioural Automaticity Index (SRBAI) score
大体时间:6 months
|
As a marker of habit formation
|
6 months
|
合作者和调查者
调查人员
- 首席研究员:Martin J Wildman, PhD、Sheffield Teaching Hospitals NHS Foundation Trust
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Behaviour change intervention的临床试验
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); PENTA...完全的
-
University of Witwatersrand, South AfricaDepartment for International Development, United Kingdom; Medical Research Council, South Africa 和其他合作者未知
-
Johns Hopkins Bloomberg School of Public HealthInnovations for Poverty Action; Investors Club/Enterprise Uganda招聘中
-
University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
-
University of Toronto Practice Based Research Network完全的
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人