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Completed

NCT Number: NCT01957072

Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Body Weight Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behaviour change intervention

Behavioral

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Acronym: PIN-CF

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2013
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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