Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— PIN-CF  

Official title:

Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957072
• Other study ID #: STH17327
• Secondary ID: IRAS Project ID
• Status: Completed
• Phase: N/A
• First received: September 30, 2013
• Last updated: March 10, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index	Unit is kg/m2	6 months	No
Other	Weight	unit is kg	6 months	No
Other	Beliefs about Medicines Questionnaire (BMQ) score	As a marker of patients' perception of their treatment	6 months	No
Other	The mean Self-Report Behavioural Automaticity Index (SRBAI) score	As a marker of habit formation	6 months	No
Primary	Proportion of patients who accepted invitation to participate as a marker of feasibility		4 weeks	No
Primary	Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility		4 weeks	No
Secondary	Participants' opinion about the behavioural intervention		6 months	No
Secondary	Participant attrition rate and phases of study whereby the attrition occurs		6 months	No
Secondary	Participants' opinion about the study processes		6 months	No
Secondary	Participants' suggestions for further improvement of the intervention and study processes		6 months	No
Secondary	Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities		2 weeks	No
Secondary	Resources needed by the investigators to deliver the intervention		6 months	No
Secondary	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	No