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

• ClinicalTrials.gov Identifier: NCT01957072
• Recruitment Status: Completed
• Last Update Posted: March 11, 2015
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Information provided by (Responsible Party): Sheffield Teaching Hospitals NHS Foundation Trust

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis	Behavioral: Behaviour change intervention	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis
• Study Start Date: February 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients who accepted invitation to participate as a marker of feasibility [ Time Frame: 4 weeks ]
2. Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

1. Participants' opinion about the behavioural intervention [ Time Frame: 6 months ]
2. Participant attrition rate and phases of study whereby the attrition occurs [ Time Frame: 6 months ]
3. Participants' opinion about the study processes [ Time Frame: 6 months ]
4. Participants' suggestions for further improvement of the intervention and study processes [ Time Frame: 6 months ]
5. Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities [ Time Frame: 2 weeks ]
6. Resources needed by the investigators to deliver the intervention [ Time Frame: 6 months ]
7. Proportion of days with missing nutritional data, as a marker for feasibility [ Time Frame: 6 months ]
   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.

Other Outcome Measures:

1. Body mass index [ Time Frame: 6 months ]
   Unit is kg/m2
2. Weight [ Time Frame: 6 months ]
   unit is kg
3. Beliefs about Medicines Questionnaire (BMQ) score [ Time Frame: 6 months ]
   As a marker of patients' perception of their treatment
4. The mean Self-Report Behavioural Automaticity Index (SRBAI) score [ Time Frame: 6 months ]
   As a marker of habit formation

Eligibility Criteria

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

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

Contacts and Locations

Locations

United Kingdom

Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom, S5 7AU

Sponsors and Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

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

More Information

• Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT01957072
• Other Study ID Numbers: STH17327; IRAS Project ID 139047 ( Other Identifier: Integrated Research Application System (IRAS) )
• First Posted: October 8, 2013
• Last Update Posted: March 11, 2015
• Last Verified: March 2015

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Cystic fibrosis; Nutrition; Weight; BMI; Behaviour change

Additional relevant MeSH terms:

Cystic Fibrosis; Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases