Pilot study of behavioural Intervention for Nutrition in CF
Research type
Research Study
Full title
Pilot study of behavioural Intervention for Nutrition in Cystic Fibrosis (PIN-CF)
IRAS ID
139047
Contact name
Martin Wildman
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Research 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 nutrient 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 to help them live healthier and longer.
It is recommended that adults with CF achieve a BMI of 23 for males and 22 for females. However, fewer than 50% of 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 how many people are needed for the larger trial.
All eligible 75 PWCF in Sheffield will be invited to participate. We 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.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0415
Date of REC Opinion
20 Jan 2014
REC opinion
Favourable Opinion