Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis

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.

Conditions

• Cystic Fibrosis

Interventions

BEHAVIORAL

Behaviour change intervention

The behaviour change intervention consists of 1. feedback via a web-based food diary 2. '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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Martin J Wildman, PhD · Sheffield Teaching Hospitals NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2014-12-31

Completion

2014-12-31

Countries

• United Kingdom

Study Locations