Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Behaviour change intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behaviour change intervention<br>Intensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months | Behavioral: Behaviour change intervention<br>* The behaviour change intervention consists of feedback via a web-based food diary 'coaching' with problem-solving and implementation plans 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.<br>|
| Other: Wait-list Control<br>Usual care for 3 months, followed by intensive behaviour change intervention for 3 months | Behavioral: Behaviour change intervention<br>* The behaviour change intervention consists of feedback via a web-based food diary 'coaching' with problem-solving and implementation plans 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who accepted invitation to participate as a marker of feasibility |  | 4 weeks | 
| Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' opinion about the behavioural intervention |  | 6 months | 
| Participant attrition rate and phases of study whereby the attrition occurs |  | 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 | 
| Resources needed by the investigators to deliver the intervention |  | 6 months | 
| Proportion of days with missing nutritional data, as a marker for feasibility | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic fibrosis, Nutrition, Weight, BMI, Behaviour change