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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01957072
First received: September 30, 2013
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention
Cystic Fibrosis
Behavioral: Behaviour change intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Proportion of patients who accepted invitation to participate as a marker of feasibility [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participants' opinion about the behavioural intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Participant attrition rate and phases of study whereby the attrition occurs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Participants' opinion about the study processes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Participants' suggestions for further improvement of the intervention and study processes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Resources needed by the investigators to deliver the intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of days with missing nutritional data, as a marker for feasibility [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Body mass index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Unit is kg/m2

  • Weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    unit is kg

  • Beliefs about Medicines Questionnaire (BMQ) score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As a marker of patients' perception of their treatment

  • The mean Self-Report Behavioural Automaticity Index (SRBAI) score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As a marker of habit formation


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Behavioral: 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.


  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957072

Contacts
Contact: Jim Lithgow, PhD 01142265424 jim.lithgow@sth.nhs.uk

Locations
United Kingdom
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Contact: Jim Lithgow, PhD    01142265424    jim.lithgow@sth.nhs.uk   
Principal Investigator: Ailsa Milne, BSc         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Martin J Wildman, PhD Sheffield Teaching Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01957072     History of Changes
Other Study ID Numbers: STH17327, IRAS Project ID 139047
Study First Received: September 30, 2013
Last Updated: February 7, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Cystic fibrosis
Nutrition
Weight
BMI
Behaviour change

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014