Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis

NCT ID: NCT01957072

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-12-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Behaviour change intervention

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

Group Type: EXPERIMENTAL

Behaviour change intervention

Intervention Type: BEHAVIORAL

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.

Wait-list Control

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

Group Type: OTHER

Behaviour change intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin J Wildman, PhD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

IRAS Project ID 139047

Identifier Type: OTHER

Identifier Source: secondary_id

STH17327

Identifier Type: -

Identifier Source: org_study_id