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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Behaviour change intervention

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7AU
      • Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behaviour change intervention; Intensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months	Behavioral: Behaviour change intervention; 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.
Other: Wait-list Control; Usual care for 3 months, followed by intensive behaviour change intervention for 3 months	Behavioral: Behaviour change intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Unit is kg/m2	6 months
Weight	unit is kg	6 months
Beliefs about Medicines Questionnaire (BMQ) score	As a marker of patients' perception of their treatment	6 months
The mean Self-Report Behavioural Automaticity Index (SRBAI) score	As a marker of habit formation	6 months

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Martin J Wildman, PhD, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 10, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Nutrition; Cystic fibrosis; BMI; Weight; Behaviour change
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: STH17327; IRAS Project ID 139047 (Other Identifier: Integrated Research Application System (IRAS))