Clinical trial NCT01957072: Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis
Official title: Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Nutrition
Weight
BMI
Behaviour change
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who accepted invitation to participate as a marker of feasibility
timeFrame: 4 weeks
measure: Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility
timeFrame: 4 weeks
Secondary outcomes:
measure: Participants' opinion about the behavioural intervention
timeFrame: 6 months
measure: Participant attrition rate and phases of study whereby the attrition occurs
timeFrame: 6 months
measure: Participants' opinion about the study processes
timeFrame: 6 months
measure: Participants' suggestions for further improvement of the intervention and study processes
timeFrame: 6 months
measure: Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
timeFrame: 2 weeks
measure: Resources needed by the investigators to deliver the intervention
timeFrame: 6 months
measure: Proportion of days with missing nutritional data, as a marker for feasibility
timeFrame: 6 months
Other outcomes:
measure: Body mass index
timeFrame: 6 months
measure: Weight
timeFrame: 6 months
measure: Beliefs about Medicines Questionnaire (BMQ) score
timeFrame: 6 months
measure: The mean Self-Report Behavioural Automaticity Index (SRBAI) score
timeFrame: 6 months
Locations:
city: Sheffield
country: United Kingdom
facility: Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Martin J Wildman, PhD
role: PRINCIPAL_INVESTIGATOR
References: