Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis (PIN-CF)

NHS Foundation Trust

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Behavioral: Behaviour change intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01957072

STH17327

IRAS Project ID 139047 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Behaviour change intervention

Experimental group

Description:

Intensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months

Treatment:

Behavioral: Behaviour change intervention

Wait-list Control

Other group

Description:

Usual care for 3 months, followed by intensive behaviour change intervention for 3 months

Treatment:

Behavioral: Behaviour change intervention